Ignite Creation Date:
2025-12-24 @ 11:58 AM
Ignite Modification Date:
2026-01-03 @ 5:57 PM
Study NCT ID:
NCT00395161
Status:
TERMINATED
Last Update Posted:
2013-04-18
First Post:
2006-10-31
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The CRISIS Prevention Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018805', 'term': 'Sepsis'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008787', 'term': 'Metoclopramide'}, {'id': 'D015032', 'term': 'Zinc'}, {'id': 'D005973', 'term': 'Glutamine'}, {'id': 'D012643', 'term': 'Selenium'}, {'id': 'D012965', 'term': 'Sodium Chloride'}, {'id': 'D000067796', 'term': 'Whey'}], 'ancestors': [{'id': 'D001549', 'term': 'Benzamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D062366', 'term': 'para-Aminobenzoates'}, {'id': 'D062365', 'term': 'Aminobenzoates'}, {'id': 'D001565', 'term': 'Benzoates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D002723', 'term': 'Chlorobenzoates'}, {'id': 'D062425', 'term': 'Hydroxybenzoate Ethers'}, {'id': 'D062385', 'term': 'Hydroxybenzoates'}, {'id': 'D006880', 'term': 'Hydroxy Acids'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D010647', 'term': 'Phenyl Ethers'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D019216', 'term': 'Metals, Heavy'}, {'id': 'D004602', 'term': 'Elements'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D028561', 'term': 'Transition Elements'}, {'id': 'D008670', 'term': 'Metals'}, {'id': 'D024361', 'term': 'Amino Acids, Basic'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D000599', 'term': 'Amino Acids, Diamino'}, {'id': 'D021542', 'term': 'Amino Acids, Neutral'}, {'id': 'D018011', 'term': 'Chalcogens'}, {'id': 'D008903', 'term': 'Minerals'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D017670', 'term': 'Sodium Compounds'}, {'id': 'D008892', 'term': 'Milk'}, {'id': 'D001628', 'term': 'Beverages'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D003611', 'term': 'Dairy Products'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jeri.burr@hsc.utah.edu', 'phone': '801-587-7753', 'title': 'Jeri Burr, MS, RN-BC, CCRC', 'organization': 'University of Utah'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': "The Data Safety Monitoring Board met on November 30, 2009. Interim analysis of the first 273 patients was presented. Per the Board's recommendations, the study was terminated based on futility."}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected for 28 days.', 'description': 'For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 148 patients receiving Daily Nutriceutical Supplementation and 139 patients receiving Whey Protein.', 'eventGroups': [{'id': 'EG000', 'title': 'Daily Nutriceutical Supplementation', 'description': 'Subjects assigned to this group received zinc (20 mg), selenium (40 mcg ages 1-3 yrs, 100 mcg age 3-5 yrs, 200 mcg age 5-12 yrs, 400 mcg adolescent), and glutamine (0.3 g/kg) each morning, and intravenous metoclopramide (0.2 mg/kg, maximum 10 mg) every 12 hrs.', 'otherNumAtRisk': 148, 'otherNumAffected': 119, 'seriousNumAtRisk': 148, 'seriousNumAffected': 73}, {'id': 'EG001', 'title': 'Whey Protein', 'description': 'Subjects assigned to the whey protein group received 0.3 g/kg beneprotein each morning and intravenous saline every 12 hrs.', 'otherNumAtRisk': 139, 'otherNumAffected': 112, 'seriousNumAtRisk': 139, 'seriousNumAffected': 70}], 'otherEvents': [{'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numEvents': 10, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 11, 'numAffected': 10}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Coagulopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Leukocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numEvents': 11, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numEvents': 19, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 15, 'numAffected': 14}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numEvents': 12, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 24, 'numAffected': 20}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 8, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numEvents': 21, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 15, 'numAffected': 15}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 13, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Emesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numEvents': 25, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 22, 'numAffected': 17}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 15, 'numAffected': 13}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Hyperthermia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numEvents': 12, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 14, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Hypothermia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numEvents': 19, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numEvents': 22, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 18, 'numAffected': 14}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Nosocomial infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 13, 'numAffected': 10}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 11, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'BUN increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numEvents': 12, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 9, 'numAffected': 8}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Blood albumin decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Blood magnesium decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numEvents': 16, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 11, 'numAffected': 10}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Blood phosphorus decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numEvents': 17, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 14, 'numAffected': 13}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Blood potassium decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 13, 'numAffected': 11}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Blood sodium decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 8, 'numAffected': 7}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Hematocrit decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numEvents': 13, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Hemoglobin decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numEvents': 14, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 17, 'numAffected': 10}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Lipase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numEvents': 14, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Oxygen saturation decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numEvents': 20, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 15, 'numAffected': 13}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'PCO2 increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 11, 'numAffected': 8}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Platelets decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 8, 'numAffected': 7}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Acidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 9, 'numAffected': 8}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Hyperglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numEvents': 27, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 21, 'numAffected': 19}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Hyperkalemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 10, 'numAffected': 8}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Hypernatremia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numEvents': 12, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 11, 'numAffected': 8}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Hypocalcemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 10, 'numAffected': 8}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Hypokalemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numEvents': 30, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 41, 'numAffected': 27}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Hypomagnesemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 12, 'numAffected': 7}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Hyponatremia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 13, 'numAffected': 11}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Hypophosphatemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 9, 'numAffected': 8}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Agitation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numEvents': 18, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 19, 'numAffected': 18}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Oliguria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 11, 'numAffected': 8}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Atelectasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numEvents': 18, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 20, 'numAffected': 17}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numEvents': 10, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 12, 'numAffected': 9}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 16, 'numAffected': 11}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Respiratory distress', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 21, 'numAffected': 13}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Stridor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Tachypnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 14, 'numAffected': 13}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Skin breakdown', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numEvents': 11, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 15, 'numAffected': 8}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numEvents': 24, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 19, 'numAffected': 16}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numEvents': 37, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 39, 'numAffected': 32}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}], 'seriousEvents': [{'term': 'Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 6, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Cardiopulmonary arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Myocardial ischemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Pericardial effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Sickle cell anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Diabetes insipidus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Cortical blindness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'GI bleed', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Gastrointestinal bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Intra-abdominal hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 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{'term': 'Respiratory distress', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Stridor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Acute hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'The Primary Endpoint of This Study is the Median Time Between Admission to the PICU and Occurrence of Nosocomial Infection or Clinical Sepsis in PICU Patients Who Have Endotracheal Tubes, Central Venous Catheters, or Urinary Catheters.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Daily Nutriceutical Supplementation', 'description': 'Subjects assigned to this group received zinc (20 mg), selenium (40 mcg ages 1-3 yrs, 100 mcg age 3-5 yrs, 200 mcg age 5-12 yrs, 400 mcg adolescent), and glutamine (0.3 g/kg) each morning, and intravenous metoclopramide (0.2 mg/kg, maximum 10 mg) every 12 hrs.'}, {'id': 'OG001', 'title': 'Whey Protein', 'description': 'Subjects assigned to the whey protein group received 0.3 g/kg beneprotein each morning and intravenous saline every 12 hrs.'}], 'classes': [{'categories': [{'measurements': [{'value': '12.1', 'groupId': 'OG000', 'lowerLimit': '9.25', 'upperLimit': '32.4'}, {'value': '13.2', 'comment': 'The upper limit of the 95% confidence interval for median number of days to event in this arm is not calculable due to an insufficient number of participants reaching the event at the final time point for assessment.', 'groupId': 'OG001', 'lowerLimit': '10.8', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '0.29', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'Null hypothesis was equal median time in both arms. Sample size calculated to yield 90% power to detect a significant effect, assuming inverse hazard rate of 1.5 using two-sided logrank test with alpha=0.05. This required recruitment until 263 patients with an event were enrolled (though the study was terminated early for futility by the DSMB).', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Two-sided logrank test was used, stratified by immune compromised status at study entry (a factor also used to stratify the study randomization)', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': '48 hours after admission until 5 days after discharged from the PICU', 'unitOfMeasure': 'Days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to treat analysis of all randomized patients.'}, {'type': 'SECONDARY', 'title': 'Rate of Nosocomial Infection or Clinical Sepsis Per 100 Study Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Daily Nutriceutical Supplementation', 'description': 'Subjects assigned to this group received zinc (20 mg), selenium (40 mcg ages 1-3 yrs, 100 mcg age 3-5 yrs, 200 mcg age 5-12 yrs, 400 mcg adolescent), and glutamine (0.3 g/kg) each morning, and intravenous metoclopramide (0.2 mg/kg, maximum 10 mg) every 12 hrs.'}, {'id': 'OG001', 'title': 'Whey Protein', 'description': 'Subjects assigned to the whey protein group received 0.3 g/kg beneprotein each morning and intravenous saline every 12 hrs.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.99', 'groupId': 'OG000', 'lowerLimit': '4.12', 'upperLimit': '5.99'}, {'value': '4.83', 'groupId': 'OG001', 'lowerLimit': '4.01', 'upperLimit': '5.77'}]}]}], 'analyses': [{'pValue': '0.81', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'Null hypothesis of equal event rates in the two study arms.', 'statisticalMethod': 'Rate analysis (see comments)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': '95% CIs were calculated for rates in each arm, and rates compared between arms, via approach of DR Cox, Biometrika (1953), vol 40, pp. 354-60.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '48 hours after PICU admission till discharge from PICU', 'unitOfMeasure': 'Mean number of events per 100 study days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized patients analyzed by intention to treat'}, {'type': 'SECONDARY', 'title': 'Antibiotic-free Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enteral Zinc, Selenium, Glutamine, and IV Metoclopramide'}, {'id': 'OG001', 'title': 'Enteral Whey Protein, IV Saline'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '5'}, {'value': '2', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '6'}]}]}], 'analyses': [{'pValue': '0.09', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': '48 hours after admission until PICU discharge', 'unitOfMeasure': 'Days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized patients per intention to treat analysis'}, {'type': 'SECONDARY', 'title': 'Incidence of Prolonged Lymphopenia (Absolute Lymphocyte Count Less Than or Equal to 1,000/mm³ for > or Equal to 7 Days)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enteral Zinc, Selenium, Glutamine, and IV Metoclopramide'}, {'id': 'OG001', 'title': 'Enteral Whey Protein, IV Saline'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.07', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'from time of PICU admission till discharge from PICU', 'description': 'What is reported is the number of participants with counts qualifying as lymphopenia.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized patients (intention to treat analysis)'}, {'type': 'SECONDARY', 'title': 'All-cause 28-day Mortality Rate.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '145', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enteral Zinc, Selenium, Glutamine, and IV Metoclopramide'}, {'id': 'OG001', 'title': 'Enteral Whey Protein, IV Saline'}], 'classes': [{'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.16', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '28 days after admission to the PICU', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'This safety outcome was analyzed by treatment received, among a total of 284 children who received treatment and had known 28-day status.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Enteral Zinc, Selenium, Glutamine, and IV Metoclopramide', 'description': 'Subjects assigned to this group received zinc (20 mg), selenium (40 mcg ages 1-3 yrs, 100 mcg age 3-5 yrs, 200 mcg age 5-12 yrs, 400 mcg adolescent), and glutamine (0.3 g/kg) each morning, and intravenous metoclopramide (0.2 mg/kg, maximum 10 mg) every 12 hrs.'}, {'id': 'FG001', 'title': 'Enteral Whey Protein, IV Saline', 'description': 'Subjects assigned to the whey protein group received 0.3 g/kg beneprotein each morning and intravenous saline every 12 hrs.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '149'}, {'groupId': 'FG001', 'numSubjects': '144'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '149'}, {'groupId': 'FG001', 'numSubjects': '144'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Dates of recruitment period: April 2007 - November 2009; Location: Pediatric Intensive Care Unit (PICU)', 'preAssignmentDetails': 'Patients were stratified according to immunocompromised status prior to randomization.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'BG000'}, {'value': '144', 'groupId': 'BG001'}, {'value': '293', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Daily Nutriceutical Supplementation', 'description': 'Subjects assigned to this group received zinc (20 mg), selenium (40 mcg ages 1-3 yrs, 100 mcg age 3-5 yrs, 200 mcg age 5-12 yrs, 400 mcg adolescent), and glutamine (0.3 g/kg) each morning, and intravenous metoclopramide (0.2 mg/kg, maximum 10 mg) every 12 hrs.'}, {'id': 'BG001', 'title': 'Whey Protein', 'description': 'Subjects assigned to the whey protein group received 0.3 g/kg beneprotein each morning and intravenous saline every 12 hrs.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '149', 'groupId': 'BG000'}, {'value': '144', 'groupId': 'BG001'}, {'value': '293', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '7.9', 'spread': '5.6', 'groupId': 'BG000'}, {'value': '8.4', 'spread': '5.9', 'groupId': 'BG001'}, {'value': '8.1', 'spread': '5.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '69', 'groupId': 'BG000'}, {'value': '79', 'groupId': 'BG001'}, {'value': '148', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '80', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '145', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '149', 'groupId': 'BG000'}, {'value': '144', 'groupId': 'BG001'}, {'value': '293', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Immune Compromised at Study Entry', 'classes': [{'title': 'Immune compromised', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}]}, {'title': 'Immune Competent', 'categories': [{'measurements': [{'value': '135', 'groupId': 'BG000'}, {'value': '133', 'groupId': 'BG001'}, {'value': '268', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'Patients were classified as immune compromised if they had acquired immunodeficiency syndrome, cancer, transplantation, primary immune deficiency or chronic immune suppressant therapy.', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 293}}, 'statusModule': {'whyStopped': 'Terminated for futility on 11/30/09 based on the recommendation of the DSMB', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2007-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-04', 'completionDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-04-16', 'studyFirstSubmitDate': '2006-10-31', 'resultsFirstSubmitDate': '2012-11-14', 'studyFirstSubmitQcDate': '2006-10-31', 'lastUpdatePostDateStruct': {'date': '2013-04-18', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-04-16', 'studyFirstPostDateStruct': {'date': '2006-11-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-04-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Primary Endpoint of This Study is the Median Time Between Admission to the PICU and Occurrence of Nosocomial Infection or Clinical Sepsis in PICU Patients Who Have Endotracheal Tubes, Central Venous Catheters, or Urinary Catheters.', 'timeFrame': '48 hours after admission until 5 days after discharged from the PICU'}], 'secondaryOutcomes': [{'measure': 'Rate of Nosocomial Infection or Clinical Sepsis Per 100 Study Days', 'timeFrame': '48 hours after PICU admission till discharge from PICU'}, {'measure': 'Antibiotic-free Days', 'timeFrame': '48 hours after admission until PICU discharge'}, {'measure': 'Incidence of Prolonged Lymphopenia (Absolute Lymphocyte Count Less Than or Equal to 1,000/mm³ for > or Equal to 7 Days)', 'timeFrame': 'from time of PICU admission till discharge from PICU', 'description': 'What is reported is the number of participants with counts qualifying as lymphopenia.'}, {'measure': 'All-cause 28-day Mortality Rate.', 'timeFrame': '28 days after admission to the PICU'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['sepsis', 'prevention', 'mineral supplementation'], 'conditions': ['Sepsis']}, 'referencesModule': {'references': [{'pmid': '12433670', 'type': 'BACKGROUND', 'citation': 'Watson RS, Carcillo JA, Linde-Zwirble WT, Clermont G, Lidicker J, Angus DC. 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Cumulative influence of organ dysfunctions and septic state on mortality of critically ill children. Am J Respir Crit Care Med. 2005 Feb 15;171(4):348-53. doi: 10.1164/rccm.200405-630OC. Epub 2004 Oct 29.'}, {'pmid': '2733733', 'type': 'BACKGROUND', 'citation': 'Klein BS, Perloff WH, Maki DG. Reduction of nosocomial infection during pediatric intensive care by protective isolation. N Engl J Med. 1989 Jun 29;320(26):1714-21. doi: 10.1056/NEJM198906293202603.'}, {'pmid': '19380753', 'type': 'BACKGROUND', 'citation': 'Carcillo J, Holubkov R, Dean JM, Berger J, Meert KL, Anand KJ, Zimmerman J, Newth CJ, Harrison R, Willson DF, Nicholson C; Eunice Kennedy Shriver National Institute of Child Health and Human Development Collaborative Pediatric Critical Care Research Network. Rationale and design of the pediatric critical illness stress-induced immune suppression (CRISIS) prevention trial. JPEN J Parenter Enteral Nutr. 2009 Jul-Aug;33(4):368-74. doi: 10.1177/0148607108327392. Epub 2009 Apr 14.'}, {'pmid': '22079954', 'type': 'RESULT', 'citation': 'Carcillo JA, Dean JM, Holubkov R, Berger J, Meert KL, Anand KJ, Zimmerman J, Newth CJ, Harrison R, Burr J, Willson DF, Nicholson C; Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Collaborative Pediatric Critical Care Research Network (CPCCRN). The randomized comparative pediatric critical illness stress-induced immune suppression (CRISIS) prevention trial. Pediatr Crit Care Med. 2012 Mar;13(2):165-73. doi: 10.1097/PCC.0b013e31823896ae.'}]}, 'descriptionModule': {'briefSummary': 'Despite strict hand washing, sterile technique, and antibiotic-coated catheters, nosocomial infection and sepsis remain the leading acquired causes of morbidity and mortality in critically ill children. Subsequent use of antibiotics to treat nosocomial infection and sepsis is considered a major attributable factor in the rise of antibiotic-resistant organisms in this population of children. This study will use a double-blind, randomized, controlled trial design to test the hypothesis that daily prophylaxis with metoclopramide, zinc, selenium and glutamine will reduce nosocomial infection and sepsis in critically ill children.', 'detailedDescription': 'Despite strict hand washing, sterile technique, and antibiotic-coated catheters, nosocomial infection and sepsis remain the leading acquired causes of morbidity and mortality in critically ill children. Subsequent use of antibiotics to treat nosocomial infection and sepsis is considered a major attributable factor in the rise of antibiotic-resistant organisms in this population of children. Presently, "prophylaxis" strategies are used to prevent stress-induced gastrointestinal bleeding; however, no "prophylaxis" strategy is used to prevent stress-induced nosocomial infection and sepsis. When left unopposed, the stress hormone, cortisol, induces lymphocyte apoptosis, lymphopenia, and immune insufficiency. Prolactin is the counter-regulatory stress hormone that prevents cortisol-induced apoptosis and immunosuppression. Zinc, selenium, and glutamine are also important in maintenance of lymphocyte health. Critically ill patients commonly develop hypoprolactinemia secondary to increased central nervous system dopaminergic activity, as well as zinc, selenium, and glutamine deficiency caused by increased utilization and decreased supply. Hypoprolactinemia can be prevented by metoclopramide, a dopamine 2 receptor antagonist commonly used as a prokinetic in children, and zinc, selenium, and glutamine deficiency can be prevented with enteral supplementation. This study will use a double-blind randomized controlled trial design to test the hypothesis that daily prophylaxis with metoclopramide, zinc, selenium and glutamine will reduce nosocomial infection and sepsis in critically ill children.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '12 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nDuring the initial accrual period for this study, prior to the first interim analysis, patients will be eligible for enrollment if they:\n\n* are between 12 months and less than 18 years; AND\n* are within the first 48 hours of the PICU admission; AND\n* have an endotracheal tube, central venous catheter (new or old, tunneled or not tunneled), or Foley catheter; AND\n* are anticipated to have an indwelling arterial or central venous catheter for blood sampling during the first three days of study enrollment.\n\nAfter the Data Safety Monitoring Board (DSMB) conducts its first interim evaluation, after enrollment of approximately 200 subjects, a decision will be made by the DSMB concerning enrollment of subjects between 40 weeks gestational age and 12 months. If the DSMB approves enrollment of infants after the first interim analysis, then patients will be eligible for enrollment if they:\n\n* are between 40 weeks gestational age and less than 18 years; AND\n* are within the first 48 hours of the PICU admission; AND\n* have an endotracheal tube, central venous catheter (new or old, tunneled or not tunneled), or Foley catheter; AND\n* are anticipated to have an indwelling arterial or central venous catheter for blood sampling during the first three days of study enrollment.\n\nExclusion Criteria:\n\nDuring the initial accrual period for this study, prior to the first interim analysis, patients will be ineligible for enrollment if ANY of the following is true or anticipated:\n\n* are less than 1 year age; OR\n* are greater than or equal to 18 years of age; OR\n* have a known allergy to metoclopramide; OR\n* planned removal of endotracheal tube, central venous catheter, AND Foley catheters, within 72 hours of study enrollment, OR\n* suspected intestinal obstruction, OR\n* intestinal surgery or bowel disruption, OR\n* chronic metoclopramide therapy prior to enrollment, OR\n* failure to enroll within 48 hours of PICU admission, OR\n* readmission to PICU in the previous 28 days, OR\n* previously enrolled in this study, OR\n* lack of commitment to aggressive intensive care therapies.\n\nAfter the Data Safety Monitoring Board (DSMB) conducts its first interim evaluation, after enrollment of approximately 200 subjects, a decision will be made by the DSMB concerning enrollment of subjects between 40 weeks gestational age and 12 months. If the DSMB approves enrollment of infants after the first interim analysis, then patients will be ineligible for enrollment if ANY of the following is true or anticipated:\n\n* are less than 40 weeks gestational age; OR\n* are greater than or equal to 18 years of age; OR\n* have a known allergy to metoclopramide; OR\n* planned removal of endotracheal tube, central venous catheter, AND Foley catheters, within 72 hours of study enrollment, OR\n* suspected intestinal obstruction'}, 'identificationModule': {'nctId': 'NCT00395161', 'acronym': 'CRISIS', 'briefTitle': 'The CRISIS Prevention Study', 'organization': {'class': 'OTHER', 'fullName': 'University of Utah'}, 'officialTitle': 'The Critical Illness Stress-induced Immune Suppression Prevention Trial', 'orgStudyIdInfo': {'id': 'U01HD049934', 'link': 'https://reporter.nih.gov/quickSearch/U01HD049934', 'type': 'NIH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'zinc selenium glutamine metoclopramide', 'description': 'metoclopramide, zinc, selenium, and glutamine', 'interventionNames': ['Drug: Metoclopramide', 'Drug: Zinc', 'Dietary Supplement: Glutamine', 'Drug: Selenium']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'enteral whey protein and IV saline', 'description': 'saline, sterile water, whey protein', 'interventionNames': ['Other: saline', 'Other: sterile water', 'Other: selenium', 'Dietary Supplement: whey-protein']}], 'interventions': [{'name': 'Metoclopramide', 'type': 'DRUG', 'otherNames': ['Reglan'], 'description': '0.2 mg/kg/dose IV every 12 hours', 'armGroupLabels': ['zinc selenium glutamine metoclopramide']}, {'name': 'Zinc', 'type': 'DRUG', 'description': 'one enteral dose daily of zinc chloride (10 mg/day elemental zinc for infants \\< or equal to one year of age, and 20 mg/day elemental zinc for patients \\> 1 year of age)', 'armGroupLabels': ['zinc selenium glutamine metoclopramide']}, {'name': 'Glutamine', 'type': 'DIETARY_SUPPLEMENT', 'description': 'one enteral dose daily of glutamine 0.3 gm/kg/day', 'armGroupLabels': ['zinc selenium glutamine metoclopramide']}, {'name': 'Selenium', 'type': 'DRUG', 'description': 'one enteral dose daily of selenium (40 μg for infants \\< 8 months of age, 60 μg for infants 8 to 12 months of age, 90 μg for children 1-3 years, 150 μg for children 4-8 years, 280 μg for children 9 to 13 years, and 400 μg for children \\> 13 years)', 'armGroupLabels': ['zinc selenium glutamine metoclopramide']}, {'name': 'saline', 'type': 'OTHER', 'description': 'equivalent volume of intravenous saline', 'armGroupLabels': ['enteral whey protein and IV saline']}, {'name': 'sterile water', 'type': 'OTHER', 'description': 'equivalent volume of sterile water', 'armGroupLabels': ['enteral whey protein and IV saline']}, {'name': 'selenium', 'type': 'OTHER', 'description': 'equivalent volume of sterile water', 'armGroupLabels': ['enteral whey protein and IV saline']}, {'name': 'whey-protein', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Beneprotein'], 'description': 'one enteral dose daily of whey-protein', 'armGroupLabels': ['enteral whey protein and IV saline']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72202', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': "Arkansas Children's Hospital", 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '90027', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Childrens Hospital of Los Angeles', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'University of California Los Angeles Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'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': '48201', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': "Children's Hospital of Michigan", 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pittsburgh Medical Center', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '98105', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': "Seattle Children's Hospital", 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Joseph Carcillo, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pittsburgh Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Michael Dean', 'class': 'OTHER'}, 'collaborators': [{'name': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)', 'class': 'NIH'}, {'name': "Seattle Children's Hospital", 'class': 'OTHER'}, {'name': "Children's Hospital Los Angeles", 'class': 'OTHER'}, {'name': "Arkansas Children's Hospital Research Institute", 'class': 'OTHER'}, {'name': "Children's Hospital of Michigan", 'class': 'OTHER'}, {'name': 'University of Pittsburgh', 'class': 'OTHER'}, {'name': "Children's National Research Institute", 'class': 'OTHER'}, {'name': 'University of California, Los Angeles', 'class': 'OTHER'}, {'name': 'Harborview Injury Prevention and Research Center', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Data Coordinating Center Principal Investigator', 'investigatorFullName': 'Michael Dean', 'investigatorAffiliation': 'University of Utah'}}}}