Ignite Creation Date:
2025-12-24 @ 7:12 PM
Ignite Modification Date:
2025-12-25 @ 4:48 PM
Study NCT ID:
NCT03545503
Status:
COMPLETED
Last Update Posted:
2021-11-26
First Post:
2018-01-31
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Evaluating the Hemodynamic Effects of Ketamine Versus Etomidate During Rapid Sequence Intubation
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2021-10-20', 'type': 'ACTUAL'}}}}, 'interventionBrowseModule': {'meshes': [{'id': 'D005045', 'term': 'Etomidate'}, {'id': 'D007649', 'term': 'Ketamine'}], 'ancestors': [{'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D003510', 'term': 'Cyclohexanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'william.powers@nhrmc.org', 'phone': '910-667-9232', 'title': 'William F. Powers, IV, MD, FACS', 'organization': 'New Hanover Regional Medical Center'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'Investigators nor clinicians were blinded to study drug. Resuscitation pre-RSI was not accounted for nor was the dosing for vascopressors. We could not control the slow administration of ketamine to decrease effects of hypotension due to rapid administration.'}}, 'adverseEventsModule': {'timeFrame': '24 hours', 'eventGroups': [{'id': 'EG000', 'title': 'Etomidate', 'description': 'Participants receiving etomidate', 'otherNumAtRisk': 194, 'deathsNumAtRisk': 194, 'otherNumAffected': 117, 'seriousNumAtRisk': 194, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Ketamine', 'description': 'Participants receiving ketamine', 'otherNumAtRisk': 204, 'deathsNumAtRisk': 204, 'otherNumAffected': 111, 'seriousNumAtRisk': 204, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Hypertension', 'notes': 'AE for HTN grade 2 and 3 is being reported here regardless of the attribution.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 117}, {'groupId': 'EG001', 'numAtRisk': 204, 'numAffected': 111}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTACE v.5.0'}, {'term': 'Hypotension', 'notes': 'AE for hypotension is being reported regardless of the grade and attribution. Note: Gr 4 is challenging to capture as participants were already being hospitalized due to their underlying condition.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 204, 'numAffected': 53}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTACE v.5.0'}], 'seriousEvents': [{'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 204, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTACE v.5.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Hemodynamic Effect as Measured by Systolic Blood Pressure Before and After RSI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '204', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Etomidate', 'description': 'Participants randomized to receive etomidate'}, {'id': 'OG001', 'title': 'Ketamine', 'description': 'Participants randomized to receive ketamine'}], 'classes': [{'title': 'Pre-SBP', 'categories': [{'measurements': [{'value': '138.04', 'spread': '38.63', 'groupId': 'OG000'}, {'value': '132.39', 'spread': '39.54', 'groupId': 'OG001'}]}]}, {'title': 'Post SBP 0-7', 'categories': [{'measurements': [{'value': '139.09', 'spread': '44.52', 'groupId': 'OG000'}, {'value': '130.09', 'spread': '41.78', 'groupId': 'OG001'}]}]}, {'title': 'Post SBP 8-15', 'categories': [{'measurements': [{'value': '130.42', 'spread': '42.19', 'groupId': 'OG000'}, {'value': '120.80', 'spread': '37.37', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'The hemodynamic response will be measured by assessing the change in vital signs between 15 minutes prior to administration and vitals up to 15 minutes after the administration of the study drug.', 'description': 'The primary outcome of this study is to determine the change in hemodynamic response comparing systolic blood pressure pre-versus post-administration of study drug. A significant hemodynamic response is defined as a decrease in systolic blood pressure of 20% or greater between the pre versus post administered study drug.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Etomidate', 'description': 'Etomidate will be dosed once at a standard of 0.3 mg/kg via IV Push\n\nEtomidate: Etomidate will be administered as the sedative for RSI on even days'}, {'id': 'FG001', 'title': 'Ketamine', 'description': 'Ketamine will be dosed once at a standard 2 mg/kg via IV Push\n\nKetamine: Ketamine will be administered as the sedative for RSI on odd days'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '208'}, {'groupId': 'FG001', 'numSubjects': '220'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '194'}, {'groupId': 'FG001', 'numSubjects': '204'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '16'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '16'}]}]}], 'recruitmentDetails': 'Participants were recruited if they required rapid sequence intubation in the pre-hospital or 17th street campus emergency department setting between January 1, 2018 and July 30, 2019.', 'preAssignmentDetails': '98 did not meet inclusion criteria, 48 had incomplete sedative data, and 71 were excluded for other reasons'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'BG000'}, {'value': '204', 'groupId': 'BG001'}, {'value': '398', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Etomidate', 'description': 'Etomidate will be dosed once at a standard of 0.3 mg/kg via IV Push\n\nEtomidate: Etomidate will be administered as the sedative for RSI on even days'}, {'id': 'BG001', 'title': 'Ketamine', 'description': 'Ketamine will be dosed once at a standard 2 mg/kg via IV Push\n\nKetamine: Ketamine will be administered as the sedative for RSI on odd days'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'BG000'}, {'value': '204', 'groupId': 'BG001'}, {'value': '398', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '57.48', 'spread': '19.5', 'groupId': 'BG000'}, {'value': '56.68', 'spread': '19.68', 'groupId': 'BG001'}, {'value': '57.08', 'spread': '19.57', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'BG000'}, {'value': '204', 'groupId': 'BG001'}, {'value': '398', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '67', 'groupId': 'BG000'}, {'value': '74', 'groupId': 'BG001'}, {'value': '141', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '127', 'groupId': 'BG000'}, {'value': '130', 'groupId': 'BG001'}, {'value': '257', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-10-01', 'size': 369360, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-09-21T10:18', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 428}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2019-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-28', 'studyFirstSubmitDate': '2018-01-31', 'resultsFirstSubmitDate': '2021-09-22', 'studyFirstSubmitQcDate': '2018-05-22', 'lastUpdatePostDateStruct': {'date': '2021-11-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-10-28', 'studyFirstPostDateStruct': {'date': '2018-06-04', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-11-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hemodynamic Effect as Measured by Systolic Blood Pressure Before and After RSI', 'timeFrame': 'The hemodynamic response will be measured by assessing the change in vital signs between 15 minutes prior to administration and vitals up to 15 minutes after the administration of the study drug.', 'description': 'The primary outcome of this study is to determine the change in hemodynamic response comparing systolic blood pressure pre-versus post-administration of study drug. A significant hemodynamic response is defined as a decrease in systolic blood pressure of 20% or greater between the pre versus post administered study drug.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Rapid Sequence Intubation', 'Hemodynamics', 'Etomidate', 'Ketamine'], 'conditions': ['Intubation Complication']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the hemodynamic effects of ketamine v etomidate during rapid sequence intubation (RSI) in the pre-hospital and emergency department setting.', 'detailedDescription': 'This is a randomized prospective study evaluating the hemodynamic response in adult participants greater than or equal to 18 years of age undergoing RSI in the pre-hospital or emergency department setting. Hemodynamic response is the cardiology response of the circulatory system. The investigators will compare the drugs Ketamine and Etomidate in participants having RSI. Ketamine and Etomidate are immediately available for RSI in both settings as both are currently standards of care for RSI.\n\nResearch thus far demonstrates that both Etomidate and ketamine are safe and effective for RSI. Despite the reported safety of Ketamine, Etomidate usage continues to far surpass that of ketamine. Both Etomidate and Ketamine are FDA-approved for induction of anesthesia. They are both ideal drugs for intubation due to their pharmacokinetic properties including a quick onset of less than 60 seconds, a short duration of about 10 minutes, and the minimal effect they have on the cardiovascular system. The neutral effect on the cardiovascular system is particularly important in the acute and traumatic setting when patients are often hypotensive.\n\nHowever, there are some differences and disadvantages in the two medications. Due to these factors and limited data to support Ketamine as an equal or superior alternative to Etomidate, it has been difficult to clearly recommend one agent over the other for RSI.\n\nData will be analyzed using SPSS with a p-value of less than 0.05 being considered significant. The PI will consider a 20% decrease in systolic BP from a participant baseline as significant, and will compare the incidence of post RSI hypotension between the two groups. Several a priori subgroups will be evaluated to include patients greater than 70 years of age, trauma participants requiring RSI, and those participants whose shock index is less than 0.9 versus those whose shock index is greater than 0.9.\n\nTo maintain 80% power with a probability of 0.05, 200 participants will be needed in each arm to detect at 25% difference in SBP (baseline to post drug administration effects)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Persons greater than 18yrs requiring rapid sequence intubation for any reason.\n\nExclusion Criteria:\n\n* Pregnant patients\n* Children under the age of 18\n* Patients with a known hypersensitivity to etomidate or ketamine'}, 'identificationModule': {'nctId': 'NCT03545503', 'acronym': 'Ket-RSI', 'briefTitle': 'Evaluating the Hemodynamic Effects of Ketamine Versus Etomidate During Rapid Sequence Intubation', 'organization': {'class': 'OTHER', 'fullName': 'South East Area Health Education Center, Wilmington, NC'}, 'officialTitle': 'A Randomized Controlled Trial to Evaluate the Hemodynamic Effects of Ketamine Versus Etomidate During Rapid Sequence Intubation', 'orgStudyIdInfo': {'id': '1712-4'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Etomidate', 'description': 'Etomidate will be dosed once at a standard of 0.3 mg/kg via IV Push', 'interventionNames': ['Drug: Etomidate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Ketamine', 'description': 'Ketamine will be dosed once at a standard 2 mg/kg via IV Push', 'interventionNames': ['Drug: Ketamine']}], 'interventions': [{'name': 'Etomidate', 'type': 'DRUG', 'otherNames': ['Amidate'], 'description': 'Etomidate will be administered as the sedative for RSI on even days', 'armGroupLabels': ['Etomidate']}, {'name': 'Ketamine', 'type': 'DRUG', 'otherNames': ['Ketalar'], 'description': 'Ketamine will be administered as the sedative for RSI on odd days', 'armGroupLabels': ['Ketamine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28401', 'city': 'Wilmington', 'state': 'North Carolina', 'country': 'United States', 'facility': 'New Hanover Regional Medical Center', 'geoPoint': {'lat': 34.23556, 'lon': -77.94604}}], 'overallOfficials': [{'name': 'William F Powers IV, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'New Hanover Regional Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'South East Area Health Education Center, Wilmington, NC', 'class': 'OTHER'}, 'collaborators': [{'name': 'New Hanover Regional Medical Center', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Surgery', 'investigatorFullName': 'William F Powers, IV, MD', 'investigatorAffiliation': 'South East Area Health Education Center, Wilmington, NC'}}}}