Ignite Creation Date:
2025-12-24 @ 6:37 PM
Ignite Modification Date:
2025-12-27 @ 12:43 AM
Study NCT ID:
NCT01701557
Status:
COMPLETED
Last Update Posted:
2012-10-05
First Post:
2012-10-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fluid Resuscitation for Pediatric Diabetic Ketoacidosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-10', 'completionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-10-03', 'studyFirstSubmitDate': '2012-10-01', 'studyFirstSubmitQcDate': '2012-10-03', 'lastUpdatePostDateStruct': {'date': '2012-10-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-10-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'time to normalization of bicarbonate and pH', 'timeFrame': 'start of treatment until resolution of DKA an expected average of 12 to 24 hours', 'description': 'Laboratory parameters were measured hourly for the first 4 hours, and every 2 to3 hours thereafter until acid-base normalization (pH was above 7.3 or the HCO3 was above 15 mmol/L)'}], 'secondaryOutcomes': [{'measure': 'the length of treatment', 'timeFrame': 'discharge from the hospital, an expected average of 1-2 days', 'description': 'Length of treatment was defined as a time of the hospital stay after the start of IVF infusion'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Ketoacidosis Fluids'], 'conditions': ['Diabetes']}, 'referencesModule': {'references': [{'pmid': '26823137', 'type': 'DERIVED', 'citation': 'Bakes K, Haukoos JS, Deakyne SJ, Hopkins E, Easter J, McFann K, Brent A, Rewers A. Effect of Volume of Fluid Resuscitation on Metabolic Normalization in Children Presenting in Diabetic Ketoacidosis: A Randomized Controlled Trial. J Emerg Med. 2016 Apr;50(4):551-9. doi: 10.1016/j.jemermed.2015.12.003. Epub 2016 Jan 25.'}]}, 'descriptionModule': {'briefSummary': 'Randomized trial to determine if the volume of fluid administration in pediatric patients with DKA impacts the rate of normalization of serum bicarbonate, pH as well as the length of treatment', 'detailedDescription': 'A randomized trial of two initial volumes of IVF and subsequent administration rates. Group I received 10 mL/kg of NS intravenous bolus over the first hour followed by ¾ NS with potassium replacement at 1.25 times maintenance and Group II received 20 mL/kg of NS intravenous bolus over the first hour followed by ¾ NS with potassium replacement at 1.5 times maintenance. The specific variables measured included demographics (age, gender, and race/ethnicity) and routine laboratory values (pH, pCO2, plasma glucose, electrolytes, bicarbonate, sodium, chloride, BUN. Length of treatment was defined as a time of the hospital stay after the start of IVF infusion.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '1 Day', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1 day to 18 years of age\n* type 1 diabetes\n* presence of DKA, as defined by glucose \\>250 mg/dl, accumulation of ketone bodies in the blood, and metabolic acidosis (venous pH \\< 7.30 or serum bicarbonate \\< 15 mmol/L.)\n\nExclusion Criteria:\n\n* requirement for additional fluid resuscitation for hemodynamic instability\n* weight greater than 70 kilograms'}, 'identificationModule': {'nctId': 'NCT01701557', 'briefTitle': 'Fluid Resuscitation for Pediatric Diabetic Ketoacidosis', 'organization': {'class': 'OTHER', 'fullName': 'University of Colorado, Denver'}, 'officialTitle': 'Fluid Resuscitation for Pediatric Diabetic Ketoacidosis', 'orgStudyIdInfo': {'id': '06-0846'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'slow fluid rate', 'description': 'bolus 10 ml/kg of NS followed by 1.25 times maintenance rate', 'interventionNames': ['Other: slow fluid rate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Fast fluid rate', 'description': 'bolus 20 ml/kg of NS followed by 1.5 times maintenance rate', 'interventionNames': ['Other: fast fluid rate']}], 'interventions': [{'name': 'slow fluid rate', 'type': 'OTHER', 'otherNames': ['normal saline'], 'description': '10 mL/kg of NS intravenous bolus over the first hour followed by ¾ NS with potassium replacement at 1.25 times maintenance', 'armGroupLabels': ['slow fluid rate']}, {'name': 'fast fluid rate', 'type': 'OTHER', 'otherNames': ['normal saline'], 'description': '20 mL/kg of NS intravenous bolus over the first hour followed by ¾ NS with potassium replacement at 1.5 times maintenance', 'armGroupLabels': ['Fast fluid rate']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'the Childrens Hospital Colorado', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}], 'overallOfficials': [{'name': 'Arleta Rewers, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Colorado, Denver'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Colorado, Denver', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}