Ignite Creation Date:
2025-12-25 @ 12:05 AM
Ignite Modification Date:
2026-03-02 @ 3:47 PM
Study NCT ID:
NCT02260258
Status:
COMPLETED
Last Update Posted:
2021-01-29
First Post:
2014-09-24
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Neuromuscular Blockade for Post-Cardiac Arrest Care
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006323', 'term': 'Heart Arrest'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077123', 'term': 'Rocuronium'}, {'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D000732', 'term': 'Androstanols'}, {'id': 'D000731', 'term': 'Androstanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mdonnino@bidmc.harvard.edu', 'phone': '6177542882', 'title': 'Mike Donnino', 'organization': 'BIDMC'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'From time of enrollment to time of discharge, an average of 7.2 days.', 'eventGroups': [{'id': 'EG000', 'title': 'Rocuronium', 'description': 'Patients will receive a bolus dose of 1 mg/kg, then a continuous I.V. infusion as per standard intensive care unit practice.\n\nOf note, protocol allows for use of cistatracurium in place of rocuronium for either reasons of drug-shortage or clinical conditions (if institutional preferences for dose adjustment in liver or renal insufficiency arise).\n\nRocuronium: Neuromuscular Blockade', 'otherNumAtRisk': 37, 'deathsNumAtRisk': 37, 'otherNumAffected': 0, 'seriousNumAtRisk': 37, 'deathsNumAffected': 23, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Usual Care', 'description': 'Patients will receive 100 mL of normal saline over 5-10 minutes at the beginning of the study in addition to usual care.\n\nNormal Saline: Normal Saline', 'otherNumAtRisk': 43, 'deathsNumAtRisk': 43, 'otherNumAffected': 0, 'seriousNumAtRisk': 43, 'deathsNumAffected': 29, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Lactate Over 24 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rocuronium', 'description': 'Patients will receive a bolus dose of 1 mg/kg, then a continuous I.V. infusion as per standard intensive care unit practice.\n\nOf note, protocol allows for use of cistatracurium in place of rocuronium for either reasons of drug-shortage or clinical conditions (if institutional preferences for dose adjustment in liver or renal insufficiency arise).\n\nRocuronium: Neuromuscular Blockade'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'Patients will receive 100 mL of normal saline over 5-10 minutes at the beginning of the study in addition to usual care.\n\nNormal Saline: Normal Saline'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.2', 'groupId': 'OG000'}, {'value': '-2.3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '24 hours', 'description': 'Change in median serum lactate level between enrollment and 24-hours after the receipt of study drug. A negative number indicates that the lactate levels were lower at 24 hours compared to their level at receipt of study drug.', 'unitOfMeasure': 'mmol/L', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change in Lactate Over 24 Hours: Effect Estimate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Effect Estimate', 'description': 'Value of the interaction term between allocated treatment and time, which is presented as a ratio of geometric mean differences over 24 hours. Values above 1.0 favor the placebo arm.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.3', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '1.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '24 hours', 'description': 'Interaction between allocated treatment and time: ratio of geometric mean differences over 24 hours in log lactate values between the two groups.', 'unitOfMeasure': 'Ratio', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Time ROSC to Target Temperature', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rocuronium', 'description': 'Patients will receive a bolus dose of 1 mg/kg, then a continuous I.V. infusion as per standard intensive care unit practice.\n\nOf note, protocol allows for use of cistatracurium in place of rocuronium for either reasons of drug-shortage or clinical conditions (if institutional preferences for dose adjustment in liver or renal insufficiency arise).\n\nRocuronium: Neuromuscular Blockade'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'Patients will receive 100 mL of normal saline over 5-10 minutes at the beginning of the study in addition to usual care.\n\nNormal Saline: Normal Saline'}], 'classes': [{'categories': [{'measurements': [{'value': '6.8', 'groupId': 'OG000', 'lowerLimit': '5.3', 'upperLimit': '9.4'}, {'value': '8.3', 'groupId': 'OG001', 'lowerLimit': '4.7', 'upperLimit': '11.2'}]}]}], 'analyses': [{'pValue': '0.82', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1', 'ciLowerLimit': '0.7', 'ciUpperLimit': '1.4', 'pValueComment': 'A priori threshold for significance 0.05', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Time variable log transformed and compared using linear regression controlling for shock stratification and site. Effect estimate represents geometric mean difference. Values above 1.0 favor longer duration in the NMB arm.'}], 'paramType': 'MEDIAN', 'timeFrame': 'Duration of hospitalization, limit 180 days', 'description': 'Time from return of spontaneous circulation to target temperature', 'unitOfMeasure': 'Hours', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Length of Intensive Care Unit (ICU) Stay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rocuronium', 'description': 'Patients will receive a bolus dose of 1 mg/kg, then a continuous I.V. infusion as per standard intensive care unit practice.\n\nOf note, protocol allows for use of cistatracurium in place of rocuronium for either reasons of drug-shortage or clinical conditions (if institutional preferences for dose adjustment in liver or renal insufficiency arise).\n\nRocuronium: Neuromuscular Blockade'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'Patients will receive 100 mL of normal saline over 5-10 minutes at the beginning of the study in addition to usual care.\n\nNormal Saline: Normal Saline'}], 'classes': [{'title': 'All patients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.0', 'groupId': 'OG000', 'lowerLimit': '3.0', 'upperLimit': '11.0'}, {'value': '4.0', 'groupId': 'OG001', 'lowerLimit': '3.0', 'upperLimit': '7.0'}]}]}, {'title': 'ICU survivors', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.0', 'groupId': 'OG000', 'lowerLimit': '6.0', 'upperLimit': '16.0'}, {'value': '5.0', 'groupId': 'OG001', 'lowerLimit': '4.0', 'upperLimit': '12.0'}]}]}], 'analyses': [{'pValue': '0.09', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Incidence rate ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.4', 'ciLowerLimit': '1.0', 'ciUpperLimit': '1.9', 'groupDescription': 'All patients analyzed (N = 37 in NMB and 43 in Usual Care)', 'statisticalMethod': 'Negative binomial regression', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'LOS truncated at 28 days and compared using negative binomial regression controlling for stratification and site. Effect estimates represent incidence rate ratios. The parameter estimate, p value and CI provided below are from the negative binomial regression carried out all patients (N = 37 in NMB and 43 in Usual Care)'}, {'pValue': '0.35', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Incidence rate ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.3', 'ciLowerLimit': '0.8', 'ciUpperLimit': '2.0', 'groupDescription': 'ICU survivors alone analyzed (n = 14 in each arm)', 'statisticalMethod': 'Negative binomial regression', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'LOS truncated at 28 days and compared using negative binomial regression controlling for stratification and site. Effect estimates represent incidence rate ratios. The parameter estimate, p value and CI provided below are from the negative binomial regression carried out on ICU survivors alone (n = 14 in NMB and 14 in Control)'}], 'paramType': 'MEDIAN', 'timeFrame': 'Length of Stay Truncated at 28 Days', 'description': 'Length of stay in ICU', 'unitOfMeasure': 'days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'ICU survivors row include only the 14 patients in each arm who survived to ICU discharge (n=14 in each arm).'}, {'type': 'SECONDARY', 'title': 'Mechanical Ventilation Duration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rocuronium', 'description': 'Patients will receive a bolus dose of 1 mg/kg, then a continuous I.V. infusion as per standard intensive care unit practice.\n\nOf note, protocol allows for use of cistatracurium in place of rocuronium for either reasons of drug-shortage or clinical conditions (if institutional preferences for dose adjustment in liver or renal insufficiency arise).\n\nRocuronium: Neuromuscular Blockade'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'Patients will receive 100 mL of normal saline over 5-10 minutes at the beginning of the study in addition to usual care.\n\nNormal Saline: Normal Saline'}], 'classes': [{'title': 'All patients', 'categories': [{'measurements': [{'value': '102.0', 'groupId': 'OG000', 'lowerLimit': '64.3', 'upperLimit': '206.4'}, {'value': '82.7', 'groupId': 'OG001', 'lowerLimit': '47.4', 'upperLimit': '160.7'}]}]}, {'title': 'Survivors to extubation', 'categories': [{'measurements': [{'value': '126.3', 'groupId': 'OG000', 'lowerLimit': '76.1', 'upperLimit': '280.6'}, {'value': '66.9', 'groupId': 'OG001', 'lowerLimit': '55.6', 'upperLimit': '172.7'}]}]}], 'analyses': [{'pValue': '0.18', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.3', 'ciLowerLimit': '0.9', 'ciUpperLimit': '1.9', 'groupDescription': 'Anaysis for the full data (n= 37 in NMB and 43 in Control)', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'EQUIVALENCE', 'statisticalComment': 'Duration log transformed and so parameter estimate represents geometric mean difference.', 'nonInferiorityComment': 'Duration log transformed and compared using linear regression controlling for shock stratification and site. Includes all patients (n=37 in NMB and n = 43 in control). Effect estimates represent geometric mean difference. Values above 1.0 favor longer duration in the NMB arm.'}, {'pValue': '0.32', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.4', 'ciLowerLimit': '0.7', 'ciUpperLimit': '2.9', 'groupDescription': 'Anaysis for the patients surviving to extubation (n= 14 in both groups)', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'EQUIVALENCE', 'statisticalComment': 'Duration log transformed and so parameter estimate represents geometric mean difference.', 'nonInferiorityComment': 'Duration log transformed and compared using linear regression controlling for shock stratification and site. Includes patients surviving to discontinuation of mechanical ventilation (n=14 in each group). Two patients discharged from the hospital on mechanical ventilation have duration truncated at time of discharge and are considered survivors to extubation. Effect estimates represent geometric mean difference. Values above 1.0 favor longer duration in the NMB arm.'}], 'paramType': 'MEDIAN', 'timeFrame': 'Duration of hospitalization, limit 180 days', 'description': 'Mechanical Ventilation Duration in Hours', 'unitOfMeasure': 'Hours', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes all patients, and also patients surviving to discontinuation of mechanical ventilation (n=14 in each group). Two patients discharged from the hospital on mechanical ventilation have duration truncated at time of discharge and are considered survivors to extubation.'}, {'type': 'SECONDARY', 'title': 'Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rocuronium', 'description': 'Patients will receive a bolus dose of 1 mg/kg, then a continuous I.V. infusion as per standard intensive care unit practice.\n\nOf note, protocol allows for use of cistatracurium in place of rocuronium for either reasons of drug-shortage or clinical conditions (if institutional preferences for dose adjustment in liver or renal insufficiency arise).\n\nRocuronium: Neuromuscular Blockade'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'Patients will receive 100 mL of normal saline over 5-10 minutes at the beginning of the study in addition to usual care.\n\nNormal Saline: Normal Saline'}], 'classes': [{'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.63', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.3', 'ciLowerLimit': '0.5', 'ciUpperLimit': '3.3', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Comparison made using logistic regression controlling for shock stratification and site. Effect estimates represent odds ratios'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Duration of hospitalization, limit 180 days', 'description': 'In-hospital survival', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Rankin Score ≤3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rocuronium', 'description': 'Patients will receive a bolus dose of 1 mg/kg, then a continuous I.V. infusion as per standard intensive care unit practice.\n\nOf note, protocol allows for use of cistatracurium in place of rocuronium for either reasons of drug-shortage or clinical conditions (if institutional preferences for dose adjustment in liver or renal insufficiency arise).\n\nRocuronium: Neuromuscular Blockade'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'Patients will receive 100 mL of normal saline over 5-10 minutes at the beginning of the study in addition to usual care.\n\nNormal Saline: Normal Saline'}], 'classes': [{'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.35', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.7', 'ciLowerLimit': '0.6', 'ciUpperLimit': '4.7', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Comparison made using logistic regression controlling for shock stratification and site. Effect estimates represent odds ratios'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Duration of hospitalization, limit 180 days', 'description': 'Modified Rankin scale to assess neurological outcome at discharge. The scale ranges from 0 to 6, and is used for measuring the performance of daily activities. The score is as follows:\n\n* 0: No symptoms\n* 1: No significant disability (able to carry out all usual activities, despite some symptoms)\n* 2: Slight disability (able to look after own affairs without assistance, but unable to carry out all previous activities)\n* 3: Moderate disability (requires some help, but able to walk unassisted)\n* 4: Moderately severe disability (unable to attend to own bodily needs without assistance, and unable to walk unassisted)\n* 5: Severe disability (requires constant nursing care and attention, bedridden, incontinent)\n* 6: Dead.\n\nHigher cores represent worse outcomes. Good and bad neurological outcome will be defined as a score of 0-3 and 4-6 respectively. This outcome reports the number of patients with a good neurological outcome( modified Rankin score ≤ 3)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Muscle Weakness Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rocuronium', 'description': 'Patients will receive a bolus dose of 1 mg/kg, then a continuous I.V. infusion as per standard intensive care unit practice.\n\nOf note, protocol allows for use of cistatracurium in place of rocuronium for either reasons of drug-shortage or clinical conditions (if institutional preferences for dose adjustment in liver or renal insufficiency arise).\n\nRocuronium: Neuromuscular Blockade'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'Patients will receive 100 mL of normal saline over 5-10 minutes at the beginning of the study in addition to usual care.\n\nNormal Saline: Normal Saline'}], 'classes': [{'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000', 'lowerLimit': '28', 'upperLimit': '30'}, {'value': '30', 'groupId': 'OG001', 'lowerLimit': '27', 'upperLimit': '30'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Duration of hospitalization, limit 180 days', 'description': "Medical Research Council Scale : Measured for 6 muscle groups (3 in the upper limbs and 3 in the lower limbs). Maximum score is 30 (grade 5 for each group) and minimum is 0 (grade 0 for each group). If muscle group strength was not symmetric bilaterally, higher measurement used. Higher scores indicate better outcomes.\n\nGrade 5: Muscle contracts normally against full resistance. Grade 4: Muscle strength is reduced but muscle contraction can still move joint against resistance.\n\nGrade 3: Muscle strength is further reduced such that the joint can be moved only against gravity with the examiner's resistance completely removed.\n\nGrade 2: Muscle can move only if the resistance of gravity is removed. As an example, the elbow can be fully flexed only if the arm is maintained in a horizontal plane.\n\nGrade 1: Only a trace or flicker of movement is seen or felt in the muscle or fasciculations are observed in the muscle.\n\nGrade 0: No movement is observed", 'unitOfMeasure': 'Points', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Rocuronium', 'description': 'Patients will receive a bolus dose of 1 mg/kg, then a continuous I.V. infusion as per standard intensive care unit practice.\n\nOf note, protocol allows for use of cistatracurium in place of rocuronium for either reasons of drug-shortage or clinical conditions (if institutional preferences for dose adjustment in liver or renal insufficiency arise).\n\nRocuronium: Neuromuscular Blockade'}, {'id': 'FG001', 'title': 'Usual Care', 'description': 'Patients will receive 100 mL of normal saline over 5-10 minutes at the beginning of the study in addition to usual care.\n\nNormal Saline: Normal Saline'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '39'}, {'groupId': 'FG001', 'numSubjects': '44'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '37'}, {'groupId': 'FG001', 'numSubjects': '43'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': '2 patients in NMB arm and 1 in control arm had clinical changes that precluded drug administration', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Between December 2014 and May 2019, we recruited adult patients (aged ≥18 years) who experienced a cardiac arrest and subsequently had sustained ROSC (≥20 minutes) but remained unresponsive and were undergoing TTM between 32℃ and 36℃. We added an additional inclusion criterion of a minimum serum lactate level of ≥2mmol/L early in study enrollment.', 'preAssignmentDetails': 'Of 818 patients assessed for eligibility, 83 met inclusion criteria and were randomized to treatment.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Rocuronium', 'description': 'Patients will receive a bolus dose of 1 mg/kg, then a continuous I.V. infusion as per standard intensive care unit practice.\n\nOf note, protocol allows for use of cistatracurium in place of rocuronium for either reasons of drug-shortage or clinical conditions (if institutional preferences for dose adjustment in liver or renal insufficiency arise).\n\nRocuronium: Neuromuscular Blockade'}, {'id': 'BG001', 'title': 'Usual Care', 'description': 'Patients will receive 100 mL of normal saline over 5-10 minutes at the beginning of the study in addition to usual care.\n\nNormal Saline: Normal Saline'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '66', 'groupId': 'BG000', 'lowerLimit': '57', 'upperLimit': '77'}, {'value': '64', 'groupId': 'BG001', 'lowerLimit': '56', 'upperLimit': '77'}, {'value': '65', 'groupId': 'BG002', 'lowerLimit': '56', 'upperLimit': '77'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Race (n, % White)', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}]}, {'title': 'Race (n, % Black/African-American)', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}]}, {'title': 'Race (n, % Asian)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Race (n, % American Indian/Native Alaskan)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Race (n, % Other)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Race (n, % Unknown/Not Reported)', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Past Medical History: Congestive Heart Failure', 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Past Medical History: Atrial Fibrillation', 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Past Medical History: Coronary Artery Disease', 'classes': [{'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Past Medical History: Prior Cardiac Arrest', 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Past Medical History: Chronic Pulmonary Disease', 'classes': [{'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Past Medical History: Liver Cirrhosis', 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Past Medical History: Kidney Disease', 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Past Medical History: Active Malignancy', 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Arrest Characteristics: Location (n, % Out of Hospital Cardiac Arrest)', 'classes': [{'categories': [{'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '75', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Arrest Characteristics: Initial Rhythm (n, % Shockable)', 'classes': [{'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Arrest Characteristics: Estimated Low-Flow Time (minutes, median, IQR)', 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000', 'lowerLimit': '0', 'upperLimit': '7'}, {'value': '2', 'groupId': 'BG001', 'lowerLimit': '0', 'upperLimit': '10'}, {'value': '3', 'groupId': 'BG002', 'lowerLimit': '0', 'upperLimit': '10'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'minutes', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Arrest Characteristics: Witnessed (n, % yes)', 'classes': [{'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Arrest Characteristics: Bystander Cardipulmonary Resuscitation (CPR) Provided (n, % yes)', 'classes': [{'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Arrest Characteristics: Arrest Etiology (n, % cardiac)', 'classes': [{'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Characteristics at Enrollment: Time from ROSC to Study Drug (hours, median, IQR)', 'classes': [{'categories': [{'measurements': [{'value': '7.5', 'groupId': 'BG000', 'lowerLimit': '6', 'upperLimit': '8.3'}, {'value': '6.3', 'groupId': 'BG001', 'lowerLimit': '5', 'upperLimit': '7.5'}, {'value': '6.5', 'groupId': 'BG002', 'lowerLimit': '5.2', 'upperLimit': '7.9'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'hours', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Characteristics at Enrollment: pH (median, IQR)', 'classes': [{'categories': [{'measurements': [{'value': '7.3', 'groupId': 'BG000', 'lowerLimit': '7.2', 'upperLimit': '7.3'}, {'value': '7.3', 'groupId': 'BG001', 'lowerLimit': '7.2', 'upperLimit': '7.4'}, {'value': '7.3', 'groupId': 'BG002', 'lowerLimit': '7.2', 'upperLimit': '7.4'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'pH', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Characteristics at Enrollment: Partial Pressure of Carbon Dioxide (pCO2) median, IQR', 'classes': [{'categories': [{'measurements': [{'value': '41.5', 'groupId': 'BG000', 'lowerLimit': '34.5', 'upperLimit': '53.5'}, {'value': '40.0', 'groupId': 'BG001', 'lowerLimit': '33.5', 'upperLimit': '48.5'}, {'value': '41.5', 'groupId': 'BG002', 'lowerLimit': '34', 'upperLimit': '49.5'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'mmHg', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Characteristics at Enrollment: Partial Pressure of Oxygen (pO2) median, IQR', 'classes': [{'categories': [{'measurements': [{'value': '100.0', 'groupId': 'BG000', 'lowerLimit': '76.0', 'upperLimit': '168.5'}, {'value': '161.0', 'groupId': 'BG001', 'lowerLimit': '83.0', 'upperLimit': '245.0'}, {'value': '132.5', 'groupId': 'BG002', 'lowerLimit': '79.5', 'upperLimit': '232'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'mmHg', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Characteristics at Enrollment: Shock Stratification (n, % shock)', 'classes': [{'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Shock stratification (n, %) refers to the number and percent of patients in each arm who were on vasopressors at the time of enrollment and therefore were considered to be in shock.', 'unitOfMeasure': 'Participants'}, {'title': 'Characteristics at Enrollment: S-T Elevation Myocardial Infarction (STEMI) present (n, % yes)', 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Characteristics at Enrollment: Target temperature (median, IQR)', 'classes': [{'categories': [{'measurements': [{'value': '35', 'groupId': 'BG000', 'lowerLimit': '33.5', 'upperLimit': '36'}, {'value': '34', 'groupId': 'BG001', 'lowerLimit': '33.5', 'upperLimit': '35.5'}, {'value': '35', 'groupId': 'BG002', 'lowerLimit': '33.5', 'upperLimit': '36'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'celsius', 'dispersionType': 'INTER_QUARTILE_RANGE'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-06-07', 'size': 272154, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_000.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2019-06-07T08:49', 'hasProtocol': False}, {'date': '2019-06-07', 'size': 156750, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_001.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-06-28T22:58', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 83}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2019-05-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-11', 'studyFirstSubmitDate': '2014-09-24', 'resultsFirstSubmitDate': '2020-06-28', 'studyFirstSubmitQcDate': '2014-10-06', 'lastUpdatePostDateStruct': {'date': '2021-01-29', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-01-11', 'studyFirstPostDateStruct': {'date': '2014-10-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-01-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-05-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Lactate Over 24 Hours', 'timeFrame': '24 hours', 'description': 'Change in median serum lactate level between enrollment and 24-hours after the receipt of study drug. A negative number indicates that the lactate levels were lower at 24 hours compared to their level at receipt of study drug.'}, {'measure': 'Change in Lactate Over 24 Hours: Effect Estimate', 'timeFrame': '24 hours', 'description': 'Interaction between allocated treatment and time: ratio of geometric mean differences over 24 hours in log lactate values between the two groups.'}], 'secondaryOutcomes': [{'measure': 'Time ROSC to Target Temperature', 'timeFrame': 'Duration of hospitalization, limit 180 days', 'description': 'Time from return of spontaneous circulation to target temperature'}, {'measure': 'Length of Intensive Care Unit (ICU) Stay', 'timeFrame': 'Length of Stay Truncated at 28 Days', 'description': 'Length of stay in ICU'}, {'measure': 'Mechanical Ventilation Duration', 'timeFrame': 'Duration of hospitalization, limit 180 days', 'description': 'Mechanical Ventilation Duration in Hours'}, {'measure': 'Survival', 'timeFrame': 'Duration of hospitalization, limit 180 days', 'description': 'In-hospital survival'}, {'measure': 'Number of Participants With Rankin Score ≤3', 'timeFrame': 'Duration of hospitalization, limit 180 days', 'description': 'Modified Rankin scale to assess neurological outcome at discharge. The scale ranges from 0 to 6, and is used for measuring the performance of daily activities. The score is as follows:\n\n* 0: No symptoms\n* 1: No significant disability (able to carry out all usual activities, despite some symptoms)\n* 2: Slight disability (able to look after own affairs without assistance, but unable to carry out all previous activities)\n* 3: Moderate disability (requires some help, but able to walk unassisted)\n* 4: Moderately severe disability (unable to attend to own bodily needs without assistance, and unable to walk unassisted)\n* 5: Severe disability (requires constant nursing care and attention, bedridden, incontinent)\n* 6: Dead.\n\nHigher cores represent worse outcomes. Good and bad neurological outcome will be defined as a score of 0-3 and 4-6 respectively. This outcome reports the number of patients with a good neurological outcome( modified Rankin score ≤ 3)'}, {'measure': 'Muscle Weakness Score', 'timeFrame': 'Duration of hospitalization, limit 180 days', 'description': "Medical Research Council Scale : Measured for 6 muscle groups (3 in the upper limbs and 3 in the lower limbs). Maximum score is 30 (grade 5 for each group) and minimum is 0 (grade 0 for each group). If muscle group strength was not symmetric bilaterally, higher measurement used. Higher scores indicate better outcomes.\n\nGrade 5: Muscle contracts normally against full resistance. Grade 4: Muscle strength is reduced but muscle contraction can still move joint against resistance.\n\nGrade 3: Muscle strength is further reduced such that the joint can be moved only against gravity with the examiner's resistance completely removed.\n\nGrade 2: Muscle can move only if the resistance of gravity is removed. As an example, the elbow can be fully flexed only if the arm is maintained in a horizontal plane.\n\nGrade 1: Only a trace or flicker of movement is seen or felt in the muscle or fasciculations are observed in the muscle.\n\nGrade 0: No movement is observed"}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Cardiac Arrest, NMB, Neuromuscular Blockade, Rocuronium'], 'conditions': ['Cardiac Arrest']}, 'referencesModule': {'references': [{'pmid': '32851921', 'type': 'DERIVED', 'citation': 'Moskowitz A, Andersen LW, Rittenberger JC, Swor R, Seethala RR, Kurz MC, Berg KM, Chase M, Cocchi MN, Grossestreuer AV, Liu X, Holmberg MJ, Callaway CW, Donnino MW. Continuous Neuromuscular Blockade Following Successful Resuscitation From Cardiac Arrest: A Randomized Trial. J Am Heart Assoc. 2020 Sep;9(17):e017171. doi: 10.1161/JAHA.120.017171. Epub 2020 Aug 27.'}]}, 'descriptionModule': {'briefSummary': 'The main purpose of this study is to evaluate if neuromuscular blockade improves lactate clearance (and preliminary secondary clinical outcome measures) as compared to usual care in post-cardiac arrest patients undergoing targeted temperature management.', 'detailedDescription': 'Out-of-hospital cardiac arrest (OHCA) occurs in more than 300,000 patients in the United States each year with an estimated mortality of greater than 90%. Unfortunately, we currently have little to offer in terms of treatment other than supportive care for the post-cardiac arrest patient. Neuromuscular blockade (NMB) is sometimes utilized in post-arrest patients particularly for the prevention of shivering. However, usage of NMB remains controversial and current American Heart Association (AHA) recommendations are to minimize utilization. Recent prospective randomized trials in patients with acute respiratory distress syndrome suggest a mortality benefit from NMB and an excellent safety profile. Furthermore, observational trials in both sepsis and post-cardiac arrest show that the use of NMB is associated with improved survival. Given this, we hypothesize that continuous NMB will be beneficial in post-arrest patients. In order to test this hypothesis, we propose a multi-center, randomized, open-label, phase II trial in post-CA patients comparing sustained NMB administration for 24 hours to standard of care after return of spontaenous circulation (ROSC). We will enroll adult, comatose OHCA patients with ROSC and will utilize an already existing clinical trials network for the completion of the study. Patients will be randomized to receive either rocuronium for 24 hours or to receive placebo with usual care. Previous data from our group has suggested that lactate levels in the post-arrest patient are a good surrogate marker for mortality. We have therefore chosen to utilize lactate levels at 24 hours as the primary endpoint for the current trial. Secondarily we will evaluate clinical endpoints including length of stay (LOS), in-hospital mortality, and good neurological outcome. We will perform a sub-study of inflammatory markers and oxygen consumption.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult (≥ 18 years)\n* Cardiac arrest with sustained return of spontaneous circulation (ROSC)\n* Comatose (i.e., not following commands) following ROSC\n* Undergoing targeted temperature management (TTM)\n* Time of enrollment ≤ 6 hours from initiation of targeted temperature management\n* Serum Lactate ≥2\n\nExclusion Criteria:\n\n* Pre-existing dementia, severe brain injury, or dependence on others for activities of daily living (i.e. a modified Rankin scale (mRS) score of 4 or higher)\n* Traumatic etiology of the cardiac arrest\n* Protected population (pregnant, prisoner)'}, 'identificationModule': {'nctId': 'NCT02260258', 'acronym': 'NMB_in_CA', 'briefTitle': 'Neuromuscular Blockade for Post-Cardiac Arrest Care', 'organization': {'class': 'OTHER', 'fullName': 'Beth Israel Deaconess Medical Center'}, 'officialTitle': 'Neuromuscular Blockade for Post-Cardiac Arrest Care', 'orgStudyIdInfo': {'id': '2014P000204'}, 'secondaryIdInfos': [{'id': '14GRNT20010002', 'type': 'OTHER_GRANT', 'domain': 'American Heart Association'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Rocuronium', 'description': 'Patients will receive a bolus dose of 1 mg/kg, then a continuous intravenous (IV) infusion as per standard intensive care unit practice.\n\nOf note, protocol allows for use of cistatracurium in place of rocuronium for either reasons of drug-shortage or clinical conditions (if institutional preferences for dose adjustment in liver or renal insufficiency arise).', 'interventionNames': ['Drug: Rocuronium']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Usual Care', 'description': 'Patients will receive 100 mL of normal saline over 5-10 minutes at the beginning of the study in addition to usual care.', 'interventionNames': ['Drug: Normal Saline']}], 'interventions': [{'name': 'Rocuronium', 'type': 'DRUG', 'description': 'Neuromuscular Blockade', 'armGroupLabels': ['Rocuronium']}, {'name': 'Normal Saline', 'type': 'DRUG', 'description': 'Normal Saline', 'armGroupLabels': ['Usual Care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Michael Kurz', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Beth Israel Deaconess Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Brigham and Women's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48073', 'city': 'Royal Oak', 'state': 'Michigan', 'country': 'United States', 'facility': 'Robert Swor', 'geoPoint': {'lat': 42.48948, 'lon': -83.14465}}, {'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pittsburgh', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}], 'overallOfficials': [{'name': 'Michael W Donnino, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Beth Israel Deaconess Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beth Israel Deaconess Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Pittsburgh Medical Center', 'class': 'OTHER'}, {'name': "Brigham and Women's Hospital", 'class': 'OTHER'}, {'name': 'University of Alabama at Birmingham', 'class': 'OTHER'}, {'name': 'Beaumont Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Michael Donnino MD', 'investigatorFullName': 'Michael Donnino', 'investigatorAffiliation': 'Beth Israel Deaconess Medical Center'}}}}