Ignite Creation Date:
2025-12-25 @ 1:32 AM
Ignite Modification Date:
2025-12-25 @ 11:45 PM
Study NCT ID:
NCT03550794
Status:
COMPLETED
Last Update Posted:
2023-06-27
First Post:
2018-05-25
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Thiamine as a Renal Protective Agent in Septic Shock
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-05-26', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D018805', 'term': 'Sepsis'}, {'id': 'D013832', 'term': 'Thiamine Deficiency'}], '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'}, {'id': 'D014804', 'term': 'Vitamin B Deficiency'}, {'id': 'D001361', 'term': 'Avitaminosis'}, {'id': 'D003677', 'term': 'Deficiency Diseases'}, {'id': 'D044342', 'term': 'Malnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000712172', 'term': 'thiamine hydrochloride'}, {'id': 'D013831', 'term': 'Thiamine'}, {'id': 'D000077330', 'term': 'Saline Solution'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'amoskowitz@montefiore.org', 'phone': '7189202956', 'title': 'Dr. Ari Moskowitz', 'organization': 'Montefiore Medical Center'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'From enrollment to time of discharge, an average of 2 weeks.', 'description': 'As detailed in the clinical trial protocol.', 'eventGroups': [{'id': 'EG000', 'title': 'Thiamine', 'description': '200mg parenterally administered thiamine hydrochloride given twice daily for a 3 days (6 doses)\n\nThiamine Hydrochloride: Thiamine hydrochloride is a water soluble vitamin (vitamin B1). 200mg of thiamine hydrochloride in 50ml 0.9%NACL will be administered twice daily for 3 days.', 'otherNumAtRisk': 42, 'deathsNumAtRisk': 42, 'otherNumAffected': 0, 'seriousNumAtRisk': 42, 'deathsNumAffected': 15, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Matching placebo (50ml 0.9%NACL) given twice daily for 3 days (6 administrations)\n\nPlacebo: 50ml of 0.9% NACL will serve as the placebo', 'otherNumAtRisk': 46, 'deathsNumAtRisk': 46, 'otherNumAffected': 0, 'seriousNumAtRisk': 46, 'deathsNumAffected': 25, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Kidney Injury Biomarker', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Thiamine', 'description': '200mg parenterally administered thiamine hydrochloride given twice daily for a 3 days (6 doses)\n\nThiamine Hydrochloride: Thiamine hydrochloride is a water soluble vitamin (vitamin B1). 200mg of thiamine hydrochloride in 50ml 0.9%NACL will be administered twice daily for 3 days.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo (50ml 0.9%NACL) given twice daily for 3 days (6 administrations)\n\nPlacebo: 50ml of 0.9% NACL will serve as the placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '2.24', 'spread': '1.50', 'groupId': 'OG000'}, {'value': '2.79', 'spread': '1.91', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.07', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.57', 'ciLowerLimit': '-1.18', 'ciUpperLimit': '0.04', 'pValueComment': 'Mixed model controlling for repeated measures within patients used to get a mean difference in creatinine between the thiamine and placebo groups at 72 hours.\n\nMissing creatinine imputed using a penalty (20pc increase) as described in SAP.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'P-value is for the comparison at 72 hours from the mixed model (i.e, not a global p-value)'}], 'paramType': 'MEAN', 'timeFrame': 'Enrollment to 72-hours', 'description': 'Change in creatinine over time', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants Receiving Renal Replacement Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Thiamine', 'description': '200mg parenterally administered thiamine hydrochloride given twice daily for a 3 days (6 doses)\n\nThiamine Hydrochloride: Thiamine hydrochloride is a water soluble vitamin (vitamin B1). 200mg of thiamine hydrochloride in 50ml 0.9%NACL will be administered twice daily for 3 days.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo (50ml 0.9%NACL) given twice daily for 3 days (6 administrations)\n\nPlacebo: 50ml of 0.9% NACL will serve as the placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.34', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.58', 'ciLowerLimit': '0.18', 'ciUpperLimit': '1.74', 'pValueComment': 'P-value from odds ratio from logistic regression model controlling for site, with outcome of receiving renal replacement therapy.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From date of enrollment until discharge from the intensive care unit (ICU) or date of death, whichever comes first, up to 60 days after enrollment', 'description': 'Number of participants who received renal replacement therapy in thiamine and placebo groups.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'ICU Free Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Thiamine', 'description': '200mg parenterally administered thiamine hydrochloride given twice daily for a 3 days (6 doses)\n\nThiamine Hydrochloride: Thiamine hydrochloride is a water soluble vitamin (vitamin B1). 200mg of thiamine hydrochloride in 50ml 0.9%NACL will be administered twice daily for 3 days.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo (50ml 0.9%NACL) given twice daily for 3 days (6 administrations)\n\nPlacebo: 50ml of 0.9% NACL will serve as the placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '22.5', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '25.0'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '23.0'}]}]}], 'analyses': [{'pValue': '0.002', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Median Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '22.0', 'ciLowerLimit': '7.4', 'ciUpperLimit': '36.6', 'pValueComment': 'P-value from quantile regression model controlling for site.', 'statisticalMethod': 'Quantile regression', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'From date of enrollment until 28 days after enrollment', 'description': 'Days alive and free of the ICU through day 28', 'unitOfMeasure': 'days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'In-hospital Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Thiamine', 'description': '200mg parenterally administered thiamine hydrochloride given twice daily for a 3 days (6 doses)\n\nThiamine Hydrochloride: Thiamine hydrochloride is a water soluble vitamin (vitamin B1). 200mg of thiamine hydrochloride in 50ml 0.9%NACL will be administered twice daily for 3 days.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo (50ml 0.9%NACL) given twice daily for 3 days (6 administrations)\n\nPlacebo: 50ml of 0.9% NACL will serve as the placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.14', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.62', 'ciLowerLimit': '0.32', 'ciUpperLimit': '1.18', 'pValueComment': 'P-value from Cox proportional hazards model adjusting for site.', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From date of enrollment until discharge from the hospital or date of death, whichever comes first, up to 60 days after enrollment', 'description': 'Length of hospital stay truncated at 60 days', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants Experiences Acute Renal Failure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Thiamine', 'description': '200mg parenterally administered thiamine hydrochloride given twice daily for a 3 days (6 doses)\n\nThiamine Hydrochloride: Thiamine hydrochloride is a water soluble vitamin (vitamin B1). 200mg of thiamine hydrochloride in 50ml 0.9%NACL will be administered twice daily for 3 days.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo (50ml 0.9%NACL) given twice daily for 3 days (6 administrations)\n\nPlacebo: 50ml of 0.9% NACL will serve as the placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.07', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.43', 'ciLowerLimit': '0.17', 'ciUpperLimit': '1.06', 'pValueComment': 'P-value from logistic regression model controlling for site', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From date of enrollment until day of discharge from the index ICU admission or date of death, whichever comes first up until 60 days post-enrollment', 'description': 'Acute renal failure as defined by the KDIGO (Kidney Disease Improving Global Outcomes) AKI (Acute Kidney Injury) criteria. In brief, a patient can meet these criteria if their serum creatinine increases (for example, serum creatinine increases to 1.5x or higher of baseline serum creatinine, or if it crosses 4mg/dL), or if renal replacement therapy is initiated, or if urine output decreases (for example, \\<0.5ml/kg/hour for 6-12 hours) or if patient becomes anuric (no urine production).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Lactate Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Thiamine', 'description': '200mg parenterally administered thiamine hydrochloride given twice daily for a 3 days (6 doses)\n\nThiamine Hydrochloride: Thiamine hydrochloride is a water soluble vitamin (vitamin B1). 200mg of thiamine hydrochloride in 50ml 0.9%NACL will be administered twice daily for 3 days.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo (50ml 0.9%NACL) given twice daily for 3 days (6 administrations)\n\nPlacebo: 50ml of 0.9% NACL will serve as the placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '1.65', 'groupId': 'OG000', 'lowerLimit': '1.10', 'upperLimit': '2.80'}, {'value': '1.95', 'groupId': 'OG001', 'lowerLimit': '1.40', 'upperLimit': '2.30'}]}]}], 'analyses': [{'pValue': '0.79', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.96', 'ciLowerLimit': '0.71', 'ciUpperLimit': '1.30', 'pValueComment': 'Mixed model controlling for repeated measures within patients used to get a mean difference in lactate between the thiamine and placebo groups at 72 hours.\n\nMissing lactate imputed using a penalty (20pc increase) as described in SAP.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'P-value is for the comparison at 72 hours from the mixed model (i.e, not a global p-value)'}], 'paramType': 'MEDIAN', 'timeFrame': 'From time of enrollment until 72 hours after enrollment', 'description': 'Change in lactate level between enrollment and 72 hours after enrollment', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Delirium on Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Thiamine', 'description': '200mg parenterally administered thiamine hydrochloride given twice daily for a 3 days (6 doses)\n\nThiamine Hydrochloride: Thiamine hydrochloride is a water soluble vitamin (vitamin B1). 200mg of thiamine hydrochloride in 50ml 0.9%NACL will be administered twice daily for 3 days.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo (50ml 0.9%NACL) given twice daily for 3 days (6 administrations)\n\nPlacebo: 50ml of 0.9% NACL will serve as the placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 3 after enrollment', 'description': 'Number of Participants with Delirium on Day 3 after enrollment', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Excludes 8 and 4 patients in intervention and placebo groups with delirium status "unable to assess"'}, {'type': 'SECONDARY', 'title': 'Change in the Sequential Organ Failure Assessment Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Thiamine', 'description': '200mg parenterally administered thiamine hydrochloride given twice daily for a 3 days (6 doses)\n\nThiamine Hydrochloride: Thiamine hydrochloride is a water soluble vitamin (vitamin B1). 200mg of thiamine hydrochloride in 50ml 0.9%NACL will be administered twice daily for 3 days.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo (50ml 0.9%NACL) given twice daily for 3 days (6 administrations)\n\nPlacebo: 50ml of 0.9% NACL will serve as the placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '8.09', 'spread': '5.60', 'groupId': 'OG000'}, {'value': '9.61', 'spread': '5.96', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.16', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.53', 'ciLowerLimit': '-3.63', 'ciUpperLimit': '0.58', 'pValueComment': 'Mixed model controlling for repeated measures within patients used to get a mean difference in SOFA scores between the thiamine and placebo groups at 72 hours.\n\nMissing SOFA imputed using a penalty (20pc increase) as described in SAP.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'P-value is for the comparison at 72 hours from the mixed model (i.e, not a global p-value)'}], 'paramType': 'MEAN', 'timeFrame': 'Time of enrollment until 72 hours after enrollment', 'description': 'Change in Sequential Organ Failure Assessment Score (SOFA) score between enrollment and 72 hours after enrollment. SOFA scores are reported on a scale between 0-24, with 0 representing best outcome and 24 representing worst outcome.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Novel Biomarkers of Renal Injury', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Thiamine', 'description': '200mg parenterally administered thiamine hydrochloride given twice daily for a 3 days (6 doses)\n\nThiamine Hydrochloride: Thiamine hydrochloride is a water soluble vitamin (vitamin B1). 200mg of thiamine hydrochloride in 50ml 0.9%NACL will be administered twice daily for 3 days.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo (50ml 0.9%NACL) given twice daily for 3 days (6 administrations)\n\nPlacebo: 50ml of 0.9% NACL will serve as the placebo'}], 'classes': [{'title': 'KIM-1', 'categories': [{'measurements': [{'value': '763.1', 'groupId': 'OG000', 'lowerLimit': '454.8', 'upperLimit': '1504.8'}, {'value': '793.9', 'groupId': 'OG001', 'lowerLimit': '350.6', 'upperLimit': '1548.8'}]}]}, {'title': 'NGAL', 'categories': [{'measurements': [{'value': '1067898.2', 'groupId': 'OG000', 'lowerLimit': '501797.2', 'upperLimit': '1528804.4'}, {'value': '1558285.0', 'groupId': 'OG001', 'lowerLimit': '966335.0', 'upperLimit': '3235305.6'}]}]}, {'title': 'Cystatin', 'categories': [{'measurements': [{'value': '1689158.2', 'groupId': 'OG000', 'lowerLimit': '1238353.1', 'upperLimit': '2677488.6'}, {'value': '2183175.4', 'groupId': 'OG001', 'lowerLimit': '1614104.4', 'upperLimit': '2819738.6'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '24 hours after enrollment', 'description': 'KIM-1, NGAL, Cystatin-C at 24-hours after enrollment', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'A total of 32 patients in thiamine and 37 patients in placebo had biomarkers available at both 0 hours and 24 hours and thus contributed to the model estimates'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Thiamine', 'description': '200mg parenterally administered thiamine hydrochloride given twice daily for a 3 days (6 doses)\n\nThiamine Hydrochloride: Thiamine hydrochloride is a water soluble vitamin (vitamin B1). 200mg of thiamine hydrochloride in 50ml 0.9%NACL will be administered twice daily for 3 days.'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Matching placebo (50ml 0.9%NACL) given twice daily for 3 days (6 administrations)\n\nPlacebo: 50ml of 0.9% NACL will serve as the placebo'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '46'}, {'groupId': 'FG001', 'numSubjects': '49'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '42'}, {'groupId': 'FG001', 'numSubjects': '46'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'No longer met inclusion criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Goals of care changed', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '88', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Thiamine', 'description': '200mg parenterally administered thiamine hydrochloride given twice daily for a 3 days (6 doses)\n\nThiamine Hydrochloride: Thiamine hydrochloride is a water soluble vitamin (vitamin B1). 200mg of thiamine hydrochloride in 50ml 0.9%NACL will be administered twice daily for 3 days.'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Matching placebo (50ml 0.9%NACL) given twice daily for 3 days (6 administrations)\n\nPlacebo: 50ml of 0.9% NACL will serve as the placebo'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '74.5', 'groupId': 'BG000', 'lowerLimit': '64.0', 'upperLimit': '83.8'}, {'value': '70.0', 'groupId': 'BG001', 'lowerLimit': '61.0', 'upperLimit': '78.0'}, {'value': '71.5', 'groupId': 'BG002', 'lowerLimit': '61.0', 'upperLimit': '81.2'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'American Indian/Native Alaskan', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Black/African American', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}, {'title': 'Not reported', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Unknown/other', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Body Mass Index', 'classes': [{'categories': [{'measurements': [{'value': '28.6', 'groupId': 'BG000', 'lowerLimit': '24.8', 'upperLimit': '32.7'}, {'value': '30.6', 'groupId': 'BG001', 'lowerLimit': '24.9', 'upperLimit': '35.9'}, {'value': '28.9', 'groupId': 'BG002', 'lowerLimit': '24.8', 'upperLimit': '34.7'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Past Medical History: Malignancy', 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Past Medical History: Coronary Artery Disease', 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Past Medical History: Congestive Heart Failure', 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Past Medical History: Liver Disease', 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Chronic Kidney Disease', 'classes': [{'title': 'No Kidney Disease', 'categories': [{'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}]}]}, {'title': 'Stage 2', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Stage 3a', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'Stage 3b', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'Stage 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Unknown/not reported', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Participants were staged using the KDIGO (Kidney disease - improving global outcomes) classification of the stages of chronic kidney disease, which uses the clinically observed glomerular filtration rate (GFR) to classify patients. A decreased GFR indicates a higher "stage" of KDIGO and thus corresponds to a worse outcome \\[A patient with stage 4 is sicker than a patient with stage 2\\].', 'unitOfMeasure': 'Participants'}, {'title': 'Source of Sepsis', 'classes': [{'categories': [{'title': 'Endocarditis', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Infection of unknown source', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Intra-abdominal infection', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}, {'title': 'Other', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}, {'title': 'Pneumonia', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}, {'title': 'Skin or soft tissue infection', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Urinary tract infection', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Volume of intravenous fluids prior to study drug', 'classes': [{'categories': [{'measurements': [{'value': '2000', 'groupId': 'BG000', 'lowerLimit': '1361.5', 'upperLimit': '3500.0'}, {'value': '1819.0', 'groupId': 'BG001', 'lowerLimit': '907.8', 'upperLimit': '3214.5'}, {'value': '1972.5', 'groupId': 'BG002', 'lowerLimit': '1138.8', 'upperLimit': '3500.0'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'mL', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Baseline cardiovascular component of the total SOFA score', 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000', 'lowerLimit': '4', 'upperLimit': '4'}, {'value': '4', 'groupId': 'BG001', 'lowerLimit': '4', 'upperLimit': '4'}, {'value': '4', 'groupId': 'BG002', 'lowerLimit': '4', 'upperLimit': '4'}]}]}], 'paramType': 'MEDIAN', 'description': 'Score on a scale that ranges from 0-24, with 24 being the worst outcome.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Time from vasopressor initiation to first study drug', 'classes': [{'categories': [{'measurements': [{'value': '12.8', 'groupId': 'BG000', 'lowerLimit': '8.3', 'upperLimit': '24.0'}, {'value': '14.4', 'groupId': 'BG001', 'lowerLimit': '8.2', 'upperLimit': '23.7'}, {'value': '14.1', 'groupId': 'BG002', 'lowerLimit': '8.2', 'upperLimit': '24.2'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'Hours', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Time from informed consent to first study drug', 'classes': [{'categories': [{'measurements': [{'value': '1.6', 'groupId': 'BG000', 'lowerLimit': '1.4', 'upperLimit': '2.2'}, {'value': '1.6', 'groupId': 'BG001', 'lowerLimit': '1.3', 'upperLimit': '1.9'}, {'value': '1.6', 'groupId': 'BG002', 'lowerLimit': '1.3', 'upperLimit': '2.0'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'Hours', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Mechanically ventilated', 'classes': [{'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Lactate', 'classes': [{'categories': [{'measurements': [{'value': '2.9', 'groupId': 'BG000', 'lowerLimit': '2.3', 'upperLimit': '4.4'}, {'value': '3.1', 'groupId': 'BG001', 'lowerLimit': '2.5', 'upperLimit': '4.7'}, {'value': '2.9', 'groupId': 'BG002', 'lowerLimit': '2.4', 'upperLimit': '4.7'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': '30-day predicted survival', 'classes': [{'title': 'High likelihood', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}]}, {'title': 'Uncertain', 'categories': [{'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}]}]}, {'title': 'Low likelihood', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-07-02', 'size': 857807, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_001.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-04-28T09:54', 'hasProtocol': True}, {'date': '2022-06-15', 'size': 439564, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_000.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-06-15T11:41', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'A randomization list will be prepared by an independent statistician using 1:1 randomization in blocks of two and four. This list will be provided to the research pharmacy, and the research pharmacy will be the only unblinded people involved with the study, and will have no patient contact or role in the analysis or other aspects of the study. Thiamine is colorless and odorless, and the 200mg dose is mixed in 5mL of normal saline. Placebo will be 50mL of normal saline and is indistinguishable in appearance from thiamine. Study team, clinical team and patient and family will all be blind to the allocation.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 95}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-09-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2022-04-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-02', 'studyFirstSubmitDate': '2018-05-25', 'resultsFirstSubmitDate': '2023-05-01', 'studyFirstSubmitQcDate': '2018-06-07', 'lastUpdatePostDateStruct': {'date': '2023-06-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-06-02', 'studyFirstPostDateStruct': {'date': '2018-06-08', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-06-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Kidney Injury Biomarker', 'timeFrame': 'Enrollment to 72-hours', 'description': 'Change in creatinine over time'}], 'secondaryOutcomes': [{'measure': 'Number of Participants Receiving Renal Replacement Therapy', 'timeFrame': 'From date of enrollment until discharge from the intensive care unit (ICU) or date of death, whichever comes first, up to 60 days after enrollment', 'description': 'Number of participants who received renal replacement therapy in thiamine and placebo groups.'}, {'measure': 'ICU Free Days', 'timeFrame': 'From date of enrollment until 28 days after enrollment', 'description': 'Days alive and free of the ICU through day 28'}, {'measure': 'In-hospital Mortality', 'timeFrame': 'From date of enrollment until discharge from the hospital or date of death, whichever comes first, up to 60 days after enrollment', 'description': 'Length of hospital stay truncated at 60 days'}, {'measure': 'Number of Participants Experiences Acute Renal Failure', 'timeFrame': 'From date of enrollment until day of discharge from the index ICU admission or date of death, whichever comes first up until 60 days post-enrollment', 'description': 'Acute renal failure as defined by the KDIGO (Kidney Disease Improving Global Outcomes) AKI (Acute Kidney Injury) criteria. In brief, a patient can meet these criteria if their serum creatinine increases (for example, serum creatinine increases to 1.5x or higher of baseline serum creatinine, or if it crosses 4mg/dL), or if renal replacement therapy is initiated, or if urine output decreases (for example, \\<0.5ml/kg/hour for 6-12 hours) or if patient becomes anuric (no urine production).'}, {'measure': 'Change in Lactate Level', 'timeFrame': 'From time of enrollment until 72 hours after enrollment', 'description': 'Change in lactate level between enrollment and 72 hours after enrollment'}, {'measure': 'Number of Participants With Delirium on Day 3', 'timeFrame': 'Day 3 after enrollment', 'description': 'Number of Participants with Delirium on Day 3 after enrollment'}, {'measure': 'Change in the Sequential Organ Failure Assessment Score', 'timeFrame': 'Time of enrollment until 72 hours after enrollment', 'description': 'Change in Sequential Organ Failure Assessment Score (SOFA) score between enrollment and 72 hours after enrollment. SOFA scores are reported on a scale between 0-24, with 0 representing best outcome and 24 representing worst outcome.'}, {'measure': 'Novel Biomarkers of Renal Injury', 'timeFrame': '24 hours after enrollment', 'description': 'KIM-1, NGAL, Cystatin-C at 24-hours after enrollment'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sepsis', 'Kidney Injury', 'Thiamine Deficiency']}, 'referencesModule': {'references': [{'pmid': '28207287', 'type': 'BACKGROUND', 'citation': 'Moskowitz A, Andersen LW, Cocchi MN, Karlsson M, Patel PV, Donnino MW. Thiamine as a Renal Protective Agent in Septic Shock. A Secondary Analysis of a Randomized, Double-Blind, Placebo-controlled Trial. Ann Am Thorac Soc. 2017 May;14(5):737-741. doi: 10.1513/AnnalsATS.201608-656BC.'}, {'pmid': '26771781', 'type': 'BACKGROUND', 'citation': 'Donnino MW, Andersen LW, Chase M, Berg KM, Tidswell M, Giberson T, Wolfe R, Moskowitz A, Smithline H, Ngo L, Cocchi MN; Center for Resuscitation Science Research Group. Randomized, Double-Blind, Placebo-Controlled Trial of Thiamine as a Metabolic Resuscitator in Septic Shock: A Pilot Study. Crit Care Med. 2016 Feb;44(2):360-7. doi: 10.1097/CCM.0000000000001572.'}, {'pmid': '38321529', 'type': 'DERIVED', 'citation': 'Vine J, Lee JH, Kravitz MS, Grossestreuer AV, Balaji L, Leland SB, Berlin N, Moskowitz A, Donnino MW. Thiamine administration in septic shock: a post hoc analysis of two randomized trials. Crit Care. 2024 Feb 6;28(1):41. doi: 10.1186/s13054-024-04818-1.'}, {'pmid': '37364280', 'type': 'DERIVED', 'citation': 'Moskowitz A, Berg KM, Grossestreuer AV, Balaji L, Liu X, Cocchi MN, Chase M, Gong MN, Gong J, Parikh SM, Ngo L, Berlin N, Donnino MW. Thiamine for Renal Protection in Septic Shock (TRPSS): A Randomized, Placebo-controlled, Clinical Trial. Am J Respir Crit Care Med. 2023 Sep 1;208(5):570-578. doi: 10.1164/rccm.202301-0034OC.'}]}, 'descriptionModule': {'briefSummary': 'This is a randomized, double-blind, placebo controlled study to investigate the effect of intravenous thiamine (vitamin B1) on renal function in septic shock.', 'detailedDescription': 'This is a randomized, double-blind, placebo controlled study to investigate the effect of intravenous thiamine (vitamin B1) on renal injury in septic shock. Patients admitted with septic shock who have a lactate of at least 2.0mmol/L and do not have pre-existing renal failure requiring dialysis will be eligible for the study. Enrolled patients will be randomized to intravenous thiamine 200mg twice daily for 6 doses or matching placebo. Blood will be drawn at several time points to assess biomarkers of renal injury. Secondary endpoints include need for renal replacement therapy, length of ICU stay, and hospital mortality.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Adult ≥18 years of age\n2. Suspected or Confirmed Infection (defined as collection of a blood/fluid culture and provision of an antimicrobial)\n3. Receipt of a vasopressor agent (e.g. norepinephrine, phenylephrine, vasopressin)\n4. Serum lactate ≥2mmol/L\n5. Creatinine \\>1.0mg/dL\n\nExclusion Criteria:\n\n1. Clinical indication for thiamine administration (alcoholism, known or highly suspected deficiency) or treatment with thiamine beyond the amount found in a standard multivitamin within the last 10 days\n2. Renal replacement therapy within the past 30 days\n3. Comfort measures only or anticipated withdrawal of support within 24 hours\n4. Protected populations (pregnant women, prisoners)\n5. Known thiamine allergy'}, 'identificationModule': {'nctId': 'NCT03550794', 'briefTitle': 'Thiamine as a Renal Protective Agent in Septic Shock', 'organization': {'class': 'OTHER', 'fullName': 'Beth Israel Deaconess Medical Center'}, 'officialTitle': 'Thiamine as a Renal Protective Agent in Septic Shock: A Randomized, Controlled Study', 'orgStudyIdInfo': {'id': '2018P-000204'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Thiamine', 'description': '200mg parenterally administered thiamine hydrochloride given twice daily for a 3 days (6 doses)', 'interventionNames': ['Drug: Thiamine Hydrochloride']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Matching placebo (50ml 0.9%NACL) given twice daily for 3 days (6 administrations)', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Thiamine Hydrochloride', 'type': 'DRUG', 'otherNames': ['Thiamine', 'Vitamin B1'], 'description': 'Thiamine hydrochloride is a water soluble vitamin (vitamin B1). 200mg of thiamine hydrochloride in 50ml 0.9%NACL will be administered twice daily for 3 days.', 'armGroupLabels': ['Thiamine']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['Normal Saline', '0.9%NACL'], 'description': '50ml of 0.9% NACL will serve as the placebo', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Beth Israel Deaconess Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '11030', 'city': 'Manhasset', 'state': 'New York', 'country': 'United States', 'facility': 'Northshore University Hospital', 'geoPoint': {'lat': 40.79788, 'lon': -73.69957}}, {'zip': '10467', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Montefiore Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '11040', 'city': 'Queens', 'state': 'New York', 'country': 'United States', 'facility': 'Long Island Jewish Hospital', 'geoPoint': {'lat': 40.68149, 'lon': -73.83652}}], 'overallOfficials': [{'name': 'Ari Moskowitz, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Beth Israel Deaconess Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beth Israel Deaconess Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Emergency Medicine', 'investigatorFullName': 'Michael Donnino', 'investigatorAffiliation': 'Beth Israel Deaconess Medical Center'}}}}