Ignite Creation Date:
2025-12-25 @ 1:14 AM
Ignite Modification Date:
2025-12-25 @ 11:23 PM
Study NCT ID:
NCT01365793
Status:
COMPLETED
Last Update Posted:
2018-06-25
First Post:
2011-06-01
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Randomized Control Trial of Fluid Therapy for Pediatric Diabetic Ketoacidosis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001929', 'term': 'Brain Edema'}, {'id': 'D016883', 'term': 'Diabetic Ketoacidosis'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D007662', 'term': 'Ketosis'}, {'id': 'D000138', 'term': 'Acidosis'}, {'id': 'D000137', 'term': 'Acid-Base Imbalance'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D048909', 'term': 'Diabetes Complications'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'nkuppermann@ucdavis.edu', 'phone': '916-734-1535', 'title': 'Nathan Kuppermann', 'organization': 'University of California, Davis (UC Davis Health)'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Fluid infusion rates for this study represent the upper and lower ends of DKA protocols in use. Rates above or below this range were not evaluated. There were fewer patients with GCS decline to \\<14 than anticipated.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Rapid Rehydration Using 0.45% Saline Replacement Fluid', 'description': 'This arm involved more rapid intravenous fluid treatment which included a second 10cc/Kg bolus of 0.9% saline and assumed a 10% fluid deficit. Intravenous fluids were infused to replace half of the estimated fluid deficit over 12 hours and the remaining half over the following 24 hours, in addition to maintenance fluids. 0.45% saline was used as the replacement fluid for this arm.', 'otherNumAtRisk': 342, 'deathsNumAtRisk': 342, 'otherNumAffected': 112, 'seriousNumAtRisk': 342, 'deathsNumAffected': 1, 'seriousNumAffected': 5}, {'id': 'EG001', 'title': 'Rapid Rehydration Using 0.9% Saline Replacement Fluid', 'description': 'This arm involved more rapid intravenous fluid treatment which included a second 10cc/Kg bolus of 0.9% saline and assumed a 10% fluid deficit. Intravenous fluids were infused to replace half of the estimated fluid deficit over 12 hours and the remaining half over the following 24 hours, in addition to maintenance fluids. 0.9% saline was used as the replacement fluid for this arm.', 'otherNumAtRisk': 344, 'deathsNumAtRisk': 344, 'otherNumAffected': 124, 'seriousNumAtRisk': 344, 'deathsNumAffected': 0, 'seriousNumAffected': 4}, {'id': 'EG002', 'title': 'Slower Rehydration Using 0.45% Saline Replacement Fluid', 'description': 'This arm involved slower rehydration (assumed 5% fluid deficit and no additional fluid bolus). Intravenous fluids were infused to replace the estimated deficit over 48 hours, in addition to maintenance fluids. 0.45% saline was used as the replacement fluid for this arm.', 'otherNumAtRisk': 338, 'deathsNumAtRisk': 338, 'otherNumAffected': 117, 'seriousNumAtRisk': 338, 'deathsNumAffected': 0, 'seriousNumAffected': 11}, {'id': 'EG003', 'title': 'Slower Rehydration Using 0.9% Saline Replacement Fluid', 'description': 'This arm involved slower rehydration (assumed 5% fluid deficit and no additional fluid bolus). Intravenous fluids were infused to replace the estimated deficit over 48 hours, in addition to maintenance fluids. 0.9% saline was used as the replacement fluid for this arm.', 'otherNumAtRisk': 347, 'deathsNumAtRisk': 347, 'otherNumAffected': 129, 'seriousNumAtRisk': 347, 'deathsNumAffected': 0, 'seriousNumAffected': 10}], 'otherEvents': [{'term': 'Coagulopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 342, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 344, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 338, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 347, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 342, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 344, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 338, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 347, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 342, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 344, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 338, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 347, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nodal Rythm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 342, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 344, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 338, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 347, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 342, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 344, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 338, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 347, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Ventricular Extrasystoles', 'stats': [{'groupId': 'EG000', 'numAtRisk': 342, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 344, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 338, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 347, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Ear pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 342, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 344, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 338, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 347, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Middle ear effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 342, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 344, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 338, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 347, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 342, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 344, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 338, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 347, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Eye irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 342, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 344, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 338, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 347, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Eye pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 342, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 344, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 338, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 347, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Ocular hyperaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 342, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 344, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 338, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 347, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 342, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 344, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 338, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 347, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 342, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 344, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 338, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 347, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 342, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 344, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 338, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 347, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal pain lower', 'stats': [{'groupId': 'EG000', 'numAtRisk': 342, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 344, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 338, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 347, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 342, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 344, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 338, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 347, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal tenderness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 342, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 344, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 338, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 347, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 342, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 344, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 338, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 347, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 342, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 344, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 338, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 347, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 342, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 344, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 338, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 347, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 342, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 344, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 338, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 347, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastrointestinal sounds abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 342, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 344, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 338, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 347, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 342, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 344, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 338, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 347, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gingival pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 342, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 344, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 338, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 347, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Glossodynia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 342, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 344, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 338, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 347, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Haematemesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 342, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 344, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 338, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 347, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Haematochezia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 342, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 344, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 338, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 347, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Mouth ulceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 342, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 344, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 338, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 347, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 342, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 344, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 338, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 347, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Oesophageal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 342, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 344, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 338, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 347, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Oesophagitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 342, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 344, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 338, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 347, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Oral Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 342, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 344, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 338, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 347, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pancreatitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 342, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 344, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 338, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 347, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Proctalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 342, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 344, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 338, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 347, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 342, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 344, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 338, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 347, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 342, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 344, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 338, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 347, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 342, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 344, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 338, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 347, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Catheter site inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 342, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 344, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 338, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 347, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Catheter site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 342, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 344, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 338, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 347, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Chest discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 342, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 344, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 338, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 347, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 342, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 344, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 338, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 347, 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'EG002', 'numAtRisk': 338, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 347, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 342, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 344, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 338, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 347, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hepatomegaly', 'stats': [{'groupId': 'EG000', 'numAtRisk': 342, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 344, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 338, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 347, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 342, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 344, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 338, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 347, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Acidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 342, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 344, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 338, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 347, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Brain oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 342, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 344, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 338, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 347, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Renal injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 342, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 344, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 338, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 347, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Acute respiratory distress syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 342, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 344, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 338, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 347, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypovolemic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 342, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 344, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 338, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 347, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 342, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 344, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 338, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 347, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Acidosis hyperchloraemic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 342, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 344, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 338, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 347, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diabetic ketoacidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 342, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 344, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 338, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 347, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 342, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 344, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 338, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 347, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cerebral infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 342, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 344, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 338, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 347, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 342, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 344, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 338, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 347, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 342, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 344, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 338, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 347, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'the Number of Participants With Glasgow Coma Score (GCS) < 14 Within the First 24 Hours of Treatment for Diabetic Ketoacidosis (DKA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '337', 'groupId': 'OG000'}, {'value': '345', 'groupId': 'OG001'}, {'value': '338', 'groupId': 'OG002'}, {'value': '341', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Rapid Rehydration Using 0.45% Saline Replacement Fluid', 'description': 'This arm involved more rapid intravenous fluid treatment which included a second 10cc/Kg bolus of 0.9% saline and assumed a 10% fluid deficit. Intravenous fluids were infused to replace half of the estimated fluid deficit over 12 hours and the remaining half over the following 24 hours, in addition to maintenance fluids. 0.45% saline was used as the replacement fluid for this arm.'}, {'id': 'OG001', 'title': 'Rapid Rehydration Using 0.9% Saline Replacement Fluid', 'description': 'This arm involved more rapid intravenous fluid treatment which included a second 10cc/Kg bolus of 0.9% saline and assumed a 10% fluid deficit. Intravenous fluids were infused to replace half of the estimated fluid deficit over 12 hours and the remaining half over the following 24 hours, in addition to maintenance fluids. 0.9% saline was used as the replacement fluid for this arm.'}, {'id': 'OG002', 'title': 'Slower Rehydration Using 0.45% Saline Replacement Fluid', 'description': 'This arm involved slower rehydration (assumed 5% fluid deficit and no additional fluid bolus). Intravenous fluids were infused to replace the estimated deficit over 48 hours, in addition to maintenance fluids. 0.45% saline was used as the replacement fluid for this arm.'}, {'id': 'OG003', 'title': 'Slower Rehydration Using 0.9% Saline Replacement Fluid', 'description': 'This arm involved slower rehydration (assumed 5% fluid deficit and no additional fluid bolus). Intravenous fluids were infused to replace the estimated deficit over 48 hours, in addition to maintenance fluids. 0.9% saline was used as the replacement fluid for this arm.'}], 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.34', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'pValueComment': 'The a priori threshold for statistical significance for each of the 2 p-values is 0.025, for an overall significance of 0.50.', 'groupDescription': 'The study uses a factorial experimental design, and tests two null hypotheses. The first of these hypotheses - the frequency of GCS score declines to \\<14 is equal between the Rapid Rehydration and Slower Rehydration groups - is reported here. The analysis of the second hypothesis is reported below.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Each statistical test uses stratification to adjust for enrolling hospital, and the arm not being tested (e.g., the test for rapid vs slower rehydration is stratified by 0.45% and 0.9% Saline, and vice versa).'}, {'pValue': '0.43', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'pValueComment': 'The a priori threshold for statistical significance for each of the 2 p-values is 0.025, for an overall significance of 0.50.', 'groupDescription': 'The study uses a factorial experimental design, and tests the two null hypotheses. The second of these hypotheses - the frequency of GCS score declines to \\<14 is equal between the 0.45% Saline group and the 0.90% Saline group - is reported here. The analysis of the first hypothesis is reported above.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Each statistical test uses stratification to adjust for enrolling hospital, and the arm not being tested (e.g., the test for rapid vs slower rehydration is stratified by 0.45% and 0.9% Saline, and vice versa).'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '24 hours', 'description': "The primary outcome is the binary indicator that a patient's GCS score drops below 14 (i.e. abnormal score) within the first 24 hours of treatment of DKA. There will be two treatment factors: sodium concentration of re-hydration fluids and rate of rehydration. These effects will be tested separately, using the Mantel-Haenszel chi-square test, stratified by hospital, and by the other main factor.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients with a GCS of 14 or 15 at randomization'}, {'type': 'SECONDARY', 'title': 'Frequency of Clinically Apparent Brain Injury', 'denoms': [{'units': 'Participants', 'counts': [{'value': '344', 'groupId': 'OG000'}, {'value': '351', 'groupId': 'OG001'}, {'value': '345', 'groupId': 'OG002'}, {'value': '349', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Rapid Rehydration Using 0.45% Saline Replacement Fluid', 'description': 'This arm involved more rapid intravenous fluid treatment which included a second 10cc/Kg bolus of 0.9% saline and assumed a 10% fluid deficit. Intravenous fluids were infused to replace half of the estimated fluid deficit over 12 hours and the remaining half over the following 24 hours, in addition to maintenance fluids. 0.45% saline was used as the replacement fluid for this arm.'}, {'id': 'OG001', 'title': 'Rapid Rehydration Using 0.9% Saline Replacement Fluid', 'description': 'This arm involved more rapid intravenous fluid treatment which included a second 10cc/Kg bolus of 0.9% saline and assumed a 10% fluid deficit. Intravenous fluids were infused to replace half of the estimated fluid deficit over 12 hours and the remaining half over the following 24 hours, in addition to maintenance fluids. 0.9% saline was used as the replacement fluid for this arm.'}, {'id': 'OG002', 'title': 'Slower Rehydration Using 0.45% Saline Replacement Fluid', 'description': 'This arm involved slower rehydration (assumed 5% fluid deficit and no additional fluid bolus). Intravenous fluids were infused to replace the estimated deficit over 48 hours, in addition to maintenance fluids. 0.45% saline was used as the replacement fluid for this arm.'}, {'id': 'OG003', 'title': 'Slower Rehydration Using 0.9% Saline Replacement Fluid', 'description': 'This arm involved slower rehydration (assumed 5% fluid deficit and no additional fluid bolus). Intravenous fluids were infused to replace the estimated deficit over 48 hours, in addition to maintenance fluids. 0.9% saline was used as the replacement fluid for this arm.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '24 hours', 'description': 'Deterioration in neurological status requiring interventions such as hyperosmolar therapy or endotracheal intubation, or resulting in death. This outcome was determined by an adjudication committee.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized patients.'}, {'type': 'SECONDARY', 'title': 'Hourly Improvement in Forward and Backward Digit Span Scores During DKA Treatment (Mean Difference Per Hour)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '344', 'groupId': 'OG000'}, {'value': '351', 'groupId': 'OG001'}, {'value': '345', 'groupId': 'OG002'}, {'value': '349', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Rapid Rehydration Using 0.45% Saline Replacement Fluid', 'description': 'This arm involved more rapid intravenous fluid treatment which included a second 10cc/Kg bolus of 0.9% saline and assumed a 10% fluid deficit. Intravenous fluids were infused to replace half of the estimated fluid deficit over 12 hours and the remaining half over the following 24 hours, in addition to maintenance fluids. 0.45% saline was used as the replacement fluid for this arm.'}, {'id': 'OG001', 'title': 'Rapid Rehydration Using 0.9% Saline Replacement Fluid', 'description': 'This arm involved more rapid intravenous fluid treatment which included a second 10cc/Kg bolus of 0.9% saline and assumed a 10% fluid deficit. Intravenous fluids were infused to replace half of the estimated fluid deficit over 12 hours and the remaining half over the following 24 hours, in addition to maintenance fluids. 0.9% saline was used as the replacement fluid for this arm.'}, {'id': 'OG002', 'title': 'Slower Rehydration Using 0.45% Saline Replacement Fluid', 'description': 'This arm involved slower rehydration (assumed 5% fluid deficit and no additional fluid bolus). Intravenous fluids were infused to replace the estimated deficit over 48 hours, in addition to maintenance fluids. 0.45% saline was used as the replacement fluid for this arm.'}, {'id': 'OG003', 'title': 'Slower Rehydration Using 0.9% Saline Replacement Fluid', 'description': 'This arm involved slower rehydration (assumed 5% fluid deficit and no additional fluid bolus). Intravenous fluids were infused to replace the estimated deficit over 48 hours, in addition to maintenance fluids. 0.9% saline was used as the replacement fluid for this arm.'}], 'classes': [{'title': 'Digit span recall test Forward slope', 'categories': [{'measurements': [{'value': '0.065', 'spread': '0.010', 'groupId': 'OG000'}, {'value': '0.058', 'spread': '0.010', 'groupId': 'OG001'}, {'value': '0.046', 'spread': '0.010', 'groupId': 'OG002'}, {'value': '0.039', 'spread': '0.010', 'groupId': 'OG003'}]}]}, {'title': 'Digit span recall test Backward slope', 'categories': [{'measurements': [{'value': '0.052', 'spread': '0.009', 'groupId': 'OG000'}, {'value': '0.053', 'spread': '0.009', 'groupId': 'OG001'}, {'value': '0.042', 'spread': '0.009', 'groupId': 'OG002'}, {'value': '0.043', 'spread': '0.009', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 hours', 'description': 'The Digit Span subtest is adapted from the Wechsler Intelligence Scale for Children, 4th version (WISC-IV) and it assesses working memory. It consists of a Digit Span Forward task in which individuals are asked to repeat numbers in the same sequence as they were presented verbally and a Digit Span Backward task in which participants repeat the numbers in the reversed order to which they were heard. Each task yields a score ranging from 0 to 16. Higher scores represent better outcomes for this test. The trajectory of digit span scores during the course of the hospitalization was used to assess improvements in mental status and whether these varied systematically as a function of treatment protocol. Digit span measurements were collected every four hours during waking hours (7AM to 10PM). The measure analyzed is the average linear change in scores between enrollment and either 24-hours or DKA resolution, whichever occurred first.', 'unitOfMeasure': 'Digit Span Change per Hour', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized patients with digit span measured during DKA'}, {'type': 'SECONDARY', 'title': 'Mean Scores on Tests of Memory Capacity 3 Months After Recovery From DKA.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '175', 'groupId': 'OG000'}, {'value': '184', 'groupId': 'OG001'}, {'value': '178', 'groupId': 'OG002'}, {'value': '176', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Rapid Rehydration Using 0.45% Saline Replacement Fluid', 'description': 'This arm involved more rapid intravenous fluid treatment which included a second 10cc/Kg bolus of 0.9% saline and assumed a 10% fluid deficit. Intravenous fluids were infused to replace half of the estimated fluid deficit over 12 hours and the remaining half over the following 24 hours, in addition to maintenance fluids. 0.45% saline was used as the replacement fluid for this arm.'}, {'id': 'OG001', 'title': 'Rapid Rehydration Using 0.9% Saline Replacement Fluid', 'description': 'This arm involved more rapid intravenous fluid treatment which included a second 10cc/Kg bolus of 0.9% saline and assumed a 10% fluid deficit. Intravenous fluids were infused to replace half of the estimated fluid deficit over 12 hours and the remaining half over the following 24 hours, in addition to maintenance fluids. 0.9% saline was used as the replacement fluid for this arm.'}, {'id': 'OG002', 'title': 'Slower Rehydration Using 0.45% Saline Replacement Fluid', 'description': 'This arm involved slower rehydration (assumed 5% fluid deficit and no additional fluid bolus). Intravenous fluids were infused to replace the estimated deficit over 48 hours, in addition to maintenance fluids. 0.45% saline was used as the replacement fluid for this arm.'}, {'id': 'OG003', 'title': 'Slower Rehydration Using 0.9% Saline Replacement Fluid', 'description': 'This arm involved slower rehydration (assumed 5% fluid deficit and no additional fluid bolus). Intravenous fluids were infused to replace the estimated deficit over 48 hours, in addition to maintenance fluids. 0.9% saline was used as the replacement fluid for this arm.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.60', 'spread': '0.14', 'groupId': 'OG000'}, {'value': '0.60', 'spread': '0.14', 'groupId': 'OG001'}, {'value': '0.61', 'spread': '0.14', 'groupId': 'OG002'}, {'value': '0.60', 'spread': '0.14', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 months', 'description': "Contextual memory was assessed via color and spatial-position tasks. Color-Task: black-ink items on a white square background were shown on a computer screen with a colored border. Subjects were asked to remember the item and the item's border color. Items were shown for 1 second, followed by a 1-second interval in which a fixation point was shown. Then, subjects were given a self-paced recognition test including studied drawings and new drawings shown in random order with no color border. Subjects determined if they had seen the drawing before. For recognized drawings, subjects reported the previously shown border color. Spatial-Position task: identical to the color task except that the items instead varied in their spatial position on the computer screen. The item-context association rate is the rate of correct item-color and item-spatial position recalled over the total of previously viewed items correctly recognized. Score range: 0-1 with higher scores indicating a better outcome.", 'unitOfMeasure': 'Item-context association rate', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized subjects aged 6 years old and older with 3-month follow-up and successful completion of memory score tests, and d-prime (a measure of chance agreement) \\>0.50'}, {'type': 'SECONDARY', 'title': 'Intelligence Quotient (IQ) Testing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '187', 'groupId': 'OG000'}, {'value': '201', 'groupId': 'OG001'}, {'value': '191', 'groupId': 'OG002'}, {'value': '189', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Rapid Rehydration Using 0.45% Saline Replacement Fluid', 'description': 'This arm involved more rapid intravenous fluid treatment which included a second 10cc/Kg bolus of 0.9% saline and assumed a 10% fluid deficit. Intravenous fluids were infused to replace half of the estimated fluid deficit over 12 hours and the remaining half over the following 24 hours, in addition to maintenance fluids. 0.45% saline was used as the replacement fluid for this arm.'}, {'id': 'OG001', 'title': 'Rapid Rehydration Using 0.9% Saline Replacement Fluid', 'description': 'This arm involved more rapid intravenous fluid treatment which included a second 10cc/Kg bolus of 0.9% saline and assumed a 10% fluid deficit. Intravenous fluids were infused to replace half of the estimated fluid deficit over 12 hours and the remaining half over the following 24 hours, in addition to maintenance fluids. 0.9% saline was used as the replacement fluid for this arm.'}, {'id': 'OG002', 'title': 'Slower Rehydration Using 0.45% Saline Replacement Fluid', 'description': 'This arm involved slower rehydration (assumed 5% fluid deficit and no additional fluid bolus). Intravenous fluids were infused to replace the estimated deficit over 48 hours, in addition to maintenance fluids. 0.45% saline was used as the replacement fluid for this arm.'}, {'id': 'OG003', 'title': 'Slower Rehydration Using 0.9% Saline Replacement Fluid', 'description': 'This arm involved slower rehydration (assumed 5% fluid deficit and no additional fluid bolus). Intravenous fluids were infused to replace the estimated deficit over 48 hours, in addition to maintenance fluids. 0.9% saline was used as the replacement fluid for this arm.'}], 'classes': [{'categories': [{'measurements': [{'value': '102', 'spread': '12', 'groupId': 'OG000'}, {'value': '102', 'spread': '13', 'groupId': 'OG001'}, {'value': '102', 'spread': '13', 'groupId': 'OG002'}, {'value': '103', 'spread': '13', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 months', 'description': 'IQ was assessed with the WASI (6-18 year olds) or WPPSI-III (3-5 year olds) at the 3 month follow-up visit. The Wechsler Abbreviated Scale of Intelligence (WASI) is a measure of IQ designed for individuals aged 6 to 89. The WASI includes four subtests; the Block Design and Matrix Reasoning tests measure Performance IQ, and the Vocabulary and Similarities tests measure Verbal IQ. Full scale IQ was computed from these scores and used for analyses. Scores typically vary from 75 to 135 with higher scores representing a better outcome.', 'unitOfMeasure': 'IQ points', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized subjects aged 3 years and older with 3-month follow-up and successful completion of IQ testing.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Rapid Rehydration Using 0.45% Saline Replacement Fluid', 'description': 'This arm involved more rapid intravenous fluid treatment which included a second 10cc/Kg bolus of 0.9% saline and assumed a 10% fluid deficit. Intravenous fluids were infused to replace half of the estimated fluid deficit over 12 hours and the remaining half over the following 24 hours, in addition to maintenance fluids. 0.45% saline was used as the replacement fluid for this arm.'}, {'id': 'FG001', 'title': 'Rapid Rehydration Using 0.9% Saline Replacement Fluid', 'description': 'This arm involved more rapid intravenous fluid treatment which included a second 10cc/Kg bolus of 0.9% saline and assumed a 10% fluid deficit. Intravenous fluids were infused to replace half of the estimated fluid deficit over 12 hours and the remaining half over the following 24 hours, in addition to maintenance fluids. 0.9% saline was used as the replacement fluid for this arm.'}, {'id': 'FG002', 'title': 'Slower Rehydration Using 0.45% Saline Replacement Fluid', 'description': 'This arm involved slower rehydration (assumed 5% fluid deficit and no additional fluid bolus). Intravenous fluids were infused to replace the estimated deficit over 48 hours, in addition to maintenance fluids. 0.45% saline was used as the replacement fluid for this arm.'}, {'id': 'FG003', 'title': 'Slower Rehydration Using 0.9% Saline Replacement Fluid', 'description': 'This arm involved slower rehydration (assumed 5% fluid deficit and no additional fluid bolus). Intravenous fluids were infused to replace the estimated deficit over 48 hours, in addition to maintenance fluids. 0.9% saline was used as the replacement fluid for this arm.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '344'}, {'groupId': 'FG001', 'numSubjects': '351'}, {'groupId': 'FG002', 'numSubjects': '345'}, {'groupId': 'FG003', 'numSubjects': '349'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '342'}, {'groupId': 'FG001', 'numSubjects': '344'}, {'groupId': 'FG002', 'numSubjects': '338'}, {'groupId': 'FG003', 'numSubjects': '347'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '344', 'groupId': 'BG000'}, {'value': '351', 'groupId': 'BG001'}, {'value': '345', 'groupId': 'BG002'}, {'value': '349', 'groupId': 'BG003'}, {'value': '1389', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Rapid Rehydration Using 0.45% Saline Replacement Fluid', 'description': 'This arm involved more rapid intravenous fluid treatment which included a second 10cc/Kg bolus of 0.9% saline and assumed a 10% fluid deficit. Intravenous fluids were infused to replace half of the estimated fluid deficit over 12 hours and the remaining half over the following 24 hours, in addition to maintenance fluids. 0.45% saline was used as the replacement fluid for this arm.'}, {'id': 'BG001', 'title': 'Rapid Rehydration Using 0.9% Saline Replacement Fluid', 'description': 'This arm involved more rapid intravenous fluid treatment which included a second 10cc/Kg bolus of 0.9% saline and assumed a 10% fluid deficit. Intravenous fluids were infused to replace half of the estimated fluid deficit over 12 hours and the remaining half over the following 24 hours, in addition to maintenance fluids. 0.9% saline was used as the replacement fluid for this arm.'}, {'id': 'BG002', 'title': 'Slower Rehydration Using 0.45% Saline Replacement Fluid', 'description': 'This arm involved slower rehydration (assumed 5% fluid deficit and no additional fluid bolus). Intravenous fluids were infused to replace the estimated deficit over 48 hours, in addition to maintenance fluids. 0.45% saline was used as the replacement fluid for this arm.'}, {'id': 'BG003', 'title': 'Slower Rehydration Using 0.9% Saline Replacement Fluid', 'description': 'This arm involved slower rehydration (assumed 5% fluid deficit and no additional fluid bolus). Intravenous fluids were infused to replace the estimated deficit over 48 hours, in addition to maintenance fluids. 0.9% saline was used as the replacement fluid for this arm.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '0 to less than 6 years old', 'categories': [{'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}, {'value': '35', 'groupId': 'BG003'}, {'value': '162', 'groupId': 'BG004'}]}]}, {'title': '6 to less than 18 years old', 'categories': [{'measurements': [{'value': '301', 'groupId': 'BG000'}, {'value': '309', 'groupId': 'BG001'}, {'value': '303', 'groupId': 'BG002'}, {'value': '314', 'groupId': 'BG003'}, {'value': '1227', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '179', 'groupId': 'BG000'}, {'value': '187', 'groupId': 'BG001'}, {'value': '187', 'groupId': 'BG002'}, {'value': '186', 'groupId': 'BG003'}, {'value': '739', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '165', 'groupId': 'BG000'}, {'value': '164', 'groupId': 'BG001'}, {'value': '158', 'groupId': 'BG002'}, {'value': '163', 'groupId': 'BG003'}, {'value': '650', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Race', 'categories': [{'title': 'White', 'measurements': [{'value': '235', 'groupId': 'BG000'}, {'value': '232', 'groupId': 'BG001'}, {'value': '247', 'groupId': 'BG002'}, {'value': '243', 'groupId': 'BG003'}, {'value': '957', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '73', 'groupId': 'BG000'}, {'value': '82', 'groupId': 'BG001'}, {'value': '68', 'groupId': 'BG002'}, {'value': '63', 'groupId': 'BG003'}, {'value': '286', 'groupId': 'BG004'}]}, {'title': 'Other', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}, {'value': '72', 'groupId': 'BG004'}]}, {'title': 'Unknown', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}, {'value': '74', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Ethnicity', 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}, {'value': '69', 'groupId': 'BG003'}, {'value': '228', 'groupId': 'BG004'}]}, {'title': 'Not Hispanic or Latino, Other, or Unknown', 'measurements': [{'value': '296', 'groupId': 'BG000'}, {'value': '289', 'groupId': 'BG001'}, {'value': '296', 'groupId': 'BG002'}, {'value': '280', 'groupId': 'BG003'}, {'value': '1161', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1389}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-06-19', 'studyFirstSubmitDate': '2011-06-01', 'resultsFirstSubmitDate': '2018-03-05', 'studyFirstSubmitQcDate': '2011-06-02', 'lastUpdatePostDateStruct': {'date': '2018-06-25', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-06-19', 'studyFirstPostDateStruct': {'date': '2011-06-03', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-06-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the Number of Participants With Glasgow Coma Score (GCS) < 14 Within the First 24 Hours of Treatment for Diabetic Ketoacidosis (DKA)', 'timeFrame': '24 hours', 'description': "The primary outcome is the binary indicator that a patient's GCS score drops below 14 (i.e. abnormal score) within the first 24 hours of treatment of DKA. There will be two treatment factors: sodium concentration of re-hydration fluids and rate of rehydration. These effects will be tested separately, using the Mantel-Haenszel chi-square test, stratified by hospital, and by the other main factor."}], 'secondaryOutcomes': [{'measure': 'Frequency of Clinically Apparent Brain Injury', 'timeFrame': '24 hours', 'description': 'Deterioration in neurological status requiring interventions such as hyperosmolar therapy or endotracheal intubation, or resulting in death. This outcome was determined by an adjudication committee.'}, {'measure': 'Hourly Improvement in Forward and Backward Digit Span Scores During DKA Treatment (Mean Difference Per Hour)', 'timeFrame': '24 hours', 'description': 'The Digit Span subtest is adapted from the Wechsler Intelligence Scale for Children, 4th version (WISC-IV) and it assesses working memory. It consists of a Digit Span Forward task in which individuals are asked to repeat numbers in the same sequence as they were presented verbally and a Digit Span Backward task in which participants repeat the numbers in the reversed order to which they were heard. Each task yields a score ranging from 0 to 16. Higher scores represent better outcomes for this test. The trajectory of digit span scores during the course of the hospitalization was used to assess improvements in mental status and whether these varied systematically as a function of treatment protocol. Digit span measurements were collected every four hours during waking hours (7AM to 10PM). The measure analyzed is the average linear change in scores between enrollment and either 24-hours or DKA resolution, whichever occurred first.'}, {'measure': 'Mean Scores on Tests of Memory Capacity 3 Months After Recovery From DKA.', 'timeFrame': '3 months', 'description': "Contextual memory was assessed via color and spatial-position tasks. Color-Task: black-ink items on a white square background were shown on a computer screen with a colored border. Subjects were asked to remember the item and the item's border color. Items were shown for 1 second, followed by a 1-second interval in which a fixation point was shown. Then, subjects were given a self-paced recognition test including studied drawings and new drawings shown in random order with no color border. Subjects determined if they had seen the drawing before. For recognized drawings, subjects reported the previously shown border color. Spatial-Position task: identical to the color task except that the items instead varied in their spatial position on the computer screen. The item-context association rate is the rate of correct item-color and item-spatial position recalled over the total of previously viewed items correctly recognized. Score range: 0-1 with higher scores indicating a better outcome."}, {'measure': 'Intelligence Quotient (IQ) Testing', 'timeFrame': '3 months', 'description': 'IQ was assessed with the WASI (6-18 year olds) or WPPSI-III (3-5 year olds) at the 3 month follow-up visit. The Wechsler Abbreviated Scale of Intelligence (WASI) is a measure of IQ designed for individuals aged 6 to 89. The WASI includes four subtests; the Block Design and Matrix Reasoning tests measure Performance IQ, and the Vocabulary and Similarities tests measure Verbal IQ. Full scale IQ was computed from these scores and used for analyses. Scores typically vary from 75 to 135 with higher scores representing a better outcome.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cerebral edema', 'diabetic ketoacidosis', 'pediatric diabetes', 'fluid therapy'], 'conditions': ['Cerebral Edema', 'Diabetic Ketoacidosis']}, 'referencesModule': {'references': [{'pmid': '23490311', 'type': 'BACKGROUND', 'citation': 'Glaser NS, Ghetti S, Casper TC, Dean JM, Kuppermann N; Pediatric Emergency Care Applied Research Network (PECARN) DKA FLUID Study Group. Pediatric diabetic ketoacidosis, fluid therapy, and cerebral injury: the design of a factorial randomized controlled trial. Pediatr Diabetes. 2013 Sep;14(6):435-46. doi: 10.1111/pedi.12027. Epub 2013 Mar 13.'}], 'seeAlsoLinks': [{'url': 'http://www.pecarn.org', 'label': 'Official website of the Pediatric Emergency Care Applied Research Network (PECARN), funded by HRSA/MCHB'}]}, 'descriptionModule': {'briefSummary': 'The investigators will conduct a randomized controlled trial comparing four different intravenous (IV) fluid treatment protocols for pediatric diabetic ketoacidosis (DKA). Two rates of rehydration will be compared; a more rapid rate and a slower rate. Within each of these two basic rehydration protocols, the investigators will vary the type of rehydration fluid used (0.9% saline or 0.45% saline). The investigators will compare the different treatments by conducting assessments of neurological injury, by measuring the frequency of significant cerebral edema, and by measuring long-term neurocognitive function.\n\nThese studies will allow us to determine whether variations in IV fluid treatment protocols affect acute neurological outcomes of DKA. Additionally, they will provide important data regarding the impact of DKA and DKA treatment on long-term neurocognitive function in children. In this way, the investigators hope to identify a more ideal fluid management strategy for children with DKA.\n\nPrevious studies have suggested that DKA may cause blood flow to the brain to be reduced and that brain injury might result from this reduction in blood flow and/or the effects of re-establishment of normal blood flow during DKA treatment with insulin and iv fluids. The investigators hypothesize that more rapidly re-establishing normal blood flow to the brain during DKA, by giving fluids more rapidly and using fluids with a higher sodium (salt) content, will help to minimize brain injury caused by DKA.', 'detailedDescription': 'These data will be compared to observational data from children with type 1 diabetes without DKA.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* must present or be transferred to a participating emergency department\n* age less than 18 years\n* diagnosis of DKA\n\n * serum glucose or fingerstick glucose concentration \\>300 mg/dL\n * venous pH \\< 7.25 OR serum bicarbonate concentration \\< 15 mmol/L.\n\nExclusion Criteria:\n\n* patients with underlying neurological disorders or neurocognitive deficits which would affect either mental status testing during treatment or subsequent neurocognitive testing after recovery\n* patients who present with concomitant alcohol or drug use, head trauma, meningitis or other conditions which might affect neurological function\n* patients transferred to one of the participating emergency departments after initiation of DKA treatment other than one 10cc/kg intravenous bolus of 0.9% saline\n* patients who are known to be pregnant at time of ED evaluation\n* patients who have been enrolled in this study twice previously\n* patients for whom the treating physician believed a specific fluid and electrolyte regimen was warranted\n* patients for whom informed consent could not be obtained within 1 hour after completion of the initial fluid bolus, or within 2 hours from initiation of fluids, whichever is longer\n* Patients who have been receiving IV fluids at a maintenance rate or greater (defined by the 4-2-1 rule) for more than two hours; OR\n* Patients for whom it has been more than four hours since DKA therapy (IV fluids, IV bolus, or IV insulin) began; OR\n* Patients who have been given hyperosmolar therapy (i.e. mannitol or 3% normal saline) prior to or since arriving at one of the participating PECARN emergency departments; OR\n* Patients for whom the treating physician intends to immediately administer hyperosmolar therapy (i.e. mannitol or 3% normal saline); OR\n* Patients whose baseline GCS is 11 or less.'}, 'identificationModule': {'nctId': 'NCT01365793', 'briefTitle': 'Randomized Control Trial of Fluid Therapy for Pediatric Diabetic Ketoacidosis', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Davis'}, 'officialTitle': 'Fluid Therapy and Cerebral Injury in Pediatric Diabetic Ketoacidosis', 'orgStudyIdInfo': {'id': '230233'}, 'secondaryIdInfos': [{'id': 'U01HD062417', 'link': 'https://reporter.nih.gov/quickSearch/U01HD062417', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Rapid rehydration using 0.45% saline replacement fluid', 'description': 'This arm will involve more rapid intravenous fluid treatment which will include a second 10cc/Kg bolus of 0.9% saline and assume a 10% fluid deficit. 0.45% saline will be used as the replacement fluid for this arm.', 'interventionNames': ['Drug: 0.45% saline replacement fluid']}, {'type': 'EXPERIMENTAL', 'label': 'Rapid rehydration using 0.9% saline replacement fluid', 'description': 'This arm will involve more rapid intravenous fluid treatment which will include a second 10cc/Kg bolus of 0.9% saline and assume a 10% fluid deficit. 0.9% saline will be used as the replacement fluid.', 'interventionNames': ['Drug: 0.9% saline replacement fluid']}, {'type': 'EXPERIMENTAL', 'label': 'Slower rehydration using 0.45% saline intravenous fluid', 'description': 'This arm will involve slower rehydration (assumed 5% fluid deficit and no additional fluid bolus) with 0.45% saline used as the replacement fluid.', 'interventionNames': ['Drug: 0.45% saline intravenous fluid']}, {'type': 'EXPERIMENTAL', 'label': 'Slower rehydration using 0.9% saline intravenous fluid', 'description': 'This arm will involve slower rehydration (assumed 5% fluid deficit and no additional fuid bolus) with 0.9% saline used as the replacement fluid.', 'interventionNames': ['Drug: 0.9% saline Intravenous fluid']}], 'interventions': [{'name': '0.45% saline replacement fluid', 'type': 'DRUG', 'description': '10cc/Kg bolus of 0.9% saline followed by 0.45% saline used as the replacement fluid', 'armGroupLabels': ['Rapid rehydration using 0.45% saline replacement fluid']}, {'name': '0.9% saline replacement fluid', 'type': 'DRUG', 'description': '10cc/Kg bolus of 0.9% saline followed by 0.9% saline used as the replacement fluid.', 'armGroupLabels': ['Rapid rehydration using 0.9% saline replacement fluid']}, {'name': '0.45% saline intravenous fluid', 'type': 'DRUG', 'description': '0.45% saline fluid', 'armGroupLabels': ['Slower rehydration using 0.45% saline intravenous fluid']}, {'name': '0.9% saline Intravenous fluid', 'type': 'DRUG', 'description': '0.9% saline fluid', 'armGroupLabels': ['Slower rehydration using 0.9% saline intravenous fluid']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95817', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'University of California, Davis', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': "Children's Hospital Colorado", 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '19803', 'city': 'Wilmington', 'state': 'Delaware', 'country': 'United States', 'facility': 'Alfred I. duPont Hospital for Children', 'geoPoint': {'lat': 39.74595, 'lon': -75.54659}}, {'zip': '20010', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': "Children's National Medical Center", 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '60614', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': "Ann & Robert Lurie Children's Hospital of Chicago", 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Children's Hospital Boston", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': "Washington University & St. Louis Children's Hospital", 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Columbia University', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '43205', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': "Nationwide Children's Hospital", 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': "The Children's Hospital of Philadelphia", 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '02903', 'city': 'Providence', 'state': 'Rhode Island', 'country': 'United States', 'facility': "Hasbro Children's Hospital/Rhode Island Hospital", 'geoPoint': {'lat': 41.82399, 'lon': -71.41283}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': "Texas Children's Hospital", 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '84158', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'University of Utah', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}], 'overallOfficials': [{'name': 'Nathan Kuppermann, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, Davis'}, {'name': 'Nicole S Glaser, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, Davis'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Davis', 'class': 'OTHER'}, 'collaborators': [{'name': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}