Ignite Creation Date:
2025-12-25 @ 12:38 AM
Ignite Modification Date:
2025-12-29 @ 3:48 AM
Study NCT ID:
NCT01169467
Status:
COMPLETED
Last Update Posted:
2015-11-02
First Post:
2010-07-22
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Cerebral Perfusion Pressure Using Precedex and Other Sedatives
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D059039', 'term': 'Standard of Care'}, {'id': 'D020927', 'term': 'Dexmedetomidine'}], 'ancestors': [{'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'keith.dombrowski@dm.duke.edu', 'phone': '(919)', 'title': 'Dr. Keith Dombrowski', 'organization': 'Duke University Medical Center'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Standard-of-Care Plus Precedex', 'description': 'Standard-of-Care plus Dexmedetomidine: Subjects who are treated with dexmedetomidine (Precedex) in addition to the standard of care sedation regiment', 'otherNumAtRisk': 44, 'otherNumAffected': 0, 'seriousNumAtRisk': 44, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Standard-of-Care', 'description': 'Subjects who are treated with the standard of care sedation regiment only.', 'otherNumAtRisk': 40, 'otherNumAffected': 0, 'seriousNumAtRisk': 40, 'seriousNumAffected': 0}], 'seriousEvents': [{'term': 'Death (Withdrawal of Life Support)', 'notes': 'Family decided to withdraw support on the patient during study period.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Variability of Intracranial Pressure (ICP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard-of-Care Plus Precedex', 'description': 'Standard-of-Care plus Dexmedetomidine: Subjects who are treated with dexmedetomidine (Precedex) in addition to the standard of care sedation regiment'}, {'id': 'OG001', 'title': 'Standard-of-Care', 'description': 'Subjects who are treated with the standard of care sedation regiment only.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.66', 'spread': '0.63', 'groupId': 'OG000'}, {'value': '5.61', 'spread': '0.64', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 24 hours', 'description': 'Variability of intracranial pressure was assessed and listed as the standard deviation of all measurements within 24 hours. Variability was assessed and listed as the standard deviation of all measurements within 24 hours', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Everyone who completed the trial was included except for fourteen subjects had incomplete data and could not be included in this analysis.'}, {'type': 'PRIMARY', 'title': 'Change in Pressure Reactivity Index (PRx)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard-of-Care Plus Precedex', 'description': 'Standard-of-Care plus Dexmedetomidine: Subjects who are treated with dexmedetomidine (Precedex) in addition to the standard of care sedation regiment'}, {'id': 'OG001', 'title': 'Standard-of-Care', 'description': 'Subjects who are treated with the standard of care sedation regiment only.'}], 'classes': [{'categories': [{'measurements': [{'value': '.64', 'spread': '.02', 'groupId': 'OG000'}, {'value': '.66', 'spread': '.02', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.395', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 24 hours', 'description': 'Using computational methods, the PRx was determined by calculating the correlation coefficient between 20 consecutive, time-averaged data points (60-second periods) of ICP and Arterial Blood Pressure (ABP).\n\nA positive PRx correlation suggests impaired cerebrovascular pressure reactivity, that is, passive transmission of changes in ABP to ICP. A negative PRx correlation indicates good pressure reactivity. Any change in ABP produces inverse changes in ICP.', 'unitOfMeasure': 'Pressure Reactivity Index', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Everyone who completed the trial was included except for nineteen subjects had incomplete data and could not be included in this analysis.'}, {'type': 'SECONDARY', 'title': 'Amount of Sedative/Analgesic Used During Treatment in Patients With Secondary Brain Injury', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard-of-Care Plus Precedex', 'description': 'Standard-of-Care plus Dexmedetomidine: Subjects who are treated with dexmedetomidine (Precedex) in addition to the standard of care sedation regiment'}, {'id': 'OG001', 'title': 'Standard-of-Care', 'description': 'Subjects who are treated with the standard of care sedation regiment only.'}], 'classes': [{'categories': [{'measurements': [{'value': '155.4', 'spread': '23.3', 'groupId': 'OG000'}, {'value': '213.1', 'spread': '26.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 hours', 'description': 'Improved physiologic Response. A lower use of sedatives or analgesic during treatment would be considered an improved physiologic response. An increase in the use of sedatives or analgesic during treatment would be considered a worse physiologic response.', 'unitOfMeasure': 'mg/ml', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Everyone who started the trial was included except for one subject had incomplete data and could not be included in this analysis.'}, {'type': 'SECONDARY', 'title': 'Cerebral Perfusion Pressure Changes in Patients With Secondary Brain Injury', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard-of-Care Plus Precedex', 'description': 'Standard-of-Care plus Dexmedetomidine: Subjects who are treated with dexmedetomidine (Precedex) in addition to the standard of care sedation regiment'}, {'id': 'OG001', 'title': 'Standard-of-Care', 'description': 'Subjects who are treated with the standard of care sedation regiment only.'}], 'classes': [{'categories': [{'measurements': [{'value': '11.5', 'spread': '.63', 'groupId': 'OG000'}, {'value': '12.3', 'spread': '.74', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 24 hours', 'description': 'Improved physiologic Response. A higher cerebral perfusion pressure during treatment would be considered an improved physiologic response. A lower cerebral perfusion pressure during treatment would be considered a worse physiologic response.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Everyone who completed the trial was included except for fourteen subjects had incomplete data and could not be included in this analysis.'}, {'type': 'SECONDARY', 'title': 'Mean Arterial Blood Pressure (MAP) Variability in Patients With Secondary Brain Injury', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard-of-Care Plus Precedex', 'description': 'Standard-of-Care plus Dexmedetomidine: Subjects who are treated with dexmedetomidine (Precedex) in addition to the standard of care sedation regiment'}, {'id': 'OG001', 'title': 'Standard-of-Care', 'description': 'Subjects who are treated with the standard of care sedation regiment only.'}], 'classes': [{'categories': [{'measurements': [{'value': '12.30', 'spread': '0.73', 'groupId': 'OG000'}, {'value': '13.8', 'spread': '1.44', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 24 hours', 'description': 'Improved physiologic Response. A lower variability of mean Arterial Blood pressure during treatment would be considered an improved physiologic response. A higher variability of mean Arterial Blood pressure during treatment would be considered a worse physiologic response. Variability was assessed and listed as the standard deviation of all measurements within 24 hours.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Everyone who started the trial was included except for seventeen subjects had incomplete data and could not be included in this analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Standard-of-Care Plus Precedex', 'description': 'Standard-of-Care plus Dexmedetomidine: Subjects who are treated with dexmedetomidine (Precedex) in addition to the standard of care sedation regiment'}, {'id': 'FG001', 'title': 'Standard-of-Care', 'description': 'Subjects who are treated with the standard of care sedation regiment only.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '44'}, {'groupId': 'FG001', 'numSubjects': '40'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '37'}, {'groupId': 'FG001', 'numSubjects': '36'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '4'}]}]}], 'recruitmentDetails': '89 subject signed consent, 5 subjects screen failed.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '84', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Standard-of-Care Plus Precedex', 'description': 'Standard-of-Care plus Dexmedetomidine: Subjects who are treated with dexmedetomidine (Precedex) in addition to the standard of care sedation regiment'}, {'id': 'BG001', 'title': 'Standard-of-Care', 'description': 'Subjects who are treated with the standard of care sedation regiment only.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '70', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '56', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '42', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 89}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-10-06', 'studyFirstSubmitDate': '2010-07-22', 'resultsFirstSubmitDate': '2014-11-05', 'studyFirstSubmitQcDate': '2010-07-22', 'lastUpdatePostDateStruct': {'date': '2015-11-02', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-10-06', 'studyFirstPostDateStruct': {'date': '2010-07-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-11-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Variability of Intracranial Pressure (ICP)', 'timeFrame': 'Baseline to 24 hours', 'description': 'Variability of intracranial pressure was assessed and listed as the standard deviation of all measurements within 24 hours. Variability was assessed and listed as the standard deviation of all measurements within 24 hours'}, {'measure': 'Change in Pressure Reactivity Index (PRx)', 'timeFrame': 'Baseline to 24 hours', 'description': 'Using computational methods, the PRx was determined by calculating the correlation coefficient between 20 consecutive, time-averaged data points (60-second periods) of ICP and Arterial Blood Pressure (ABP).\n\nA positive PRx correlation suggests impaired cerebrovascular pressure reactivity, that is, passive transmission of changes in ABP to ICP. A negative PRx correlation indicates good pressure reactivity. Any change in ABP produces inverse changes in ICP.'}], 'secondaryOutcomes': [{'measure': 'Amount of Sedative/Analgesic Used During Treatment in Patients With Secondary Brain Injury', 'timeFrame': '24 hours', 'description': 'Improved physiologic Response. A lower use of sedatives or analgesic during treatment would be considered an improved physiologic response. An increase in the use of sedatives or analgesic during treatment would be considered a worse physiologic response.'}, {'measure': 'Cerebral Perfusion Pressure Changes in Patients With Secondary Brain Injury', 'timeFrame': 'Baseline to 24 hours', 'description': 'Improved physiologic Response. A higher cerebral perfusion pressure during treatment would be considered an improved physiologic response. A lower cerebral perfusion pressure during treatment would be considered a worse physiologic response.'}, {'measure': 'Mean Arterial Blood Pressure (MAP) Variability in Patients With Secondary Brain Injury', 'timeFrame': 'Baseline to 24 hours', 'description': 'Improved physiologic Response. A lower variability of mean Arterial Blood pressure during treatment would be considered an improved physiologic response. A higher variability of mean Arterial Blood pressure during treatment would be considered a worse physiologic response. Variability was assessed and listed as the standard deviation of all measurements within 24 hours.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Endotracheal Intubation', 'Continuous IV Sedation', 'ICP Monitoring']}, 'referencesModule': {'references': [{'pmid': '24506248', 'type': 'BACKGROUND', 'citation': 'Lazaridis C, DeSantis SM, Smielewski P, Menon DK, Hutchinson P, Pickard JD, Czosnyka M. Patient-specific thresholds of intracranial pressure in severe traumatic brain injury. J Neurosurg. 2014 Apr;120(4):893-900. doi: 10.3171/2014.1.JNS131292. Epub 2014 Feb 7.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to examine the effects of using dexmedetomidine (Precedex) in addition to the current standard-of-care for sedation.', 'detailedDescription': 'Primarily, this study seeks to explore whether there is a difference in mean arterial pressure (MAP) variability, incidence of intracranial hypertension, intracranial pressure (ICP) variability, cerebral perfusion pressure (CPP) and Cerebrovascular pressure reactivity index (PRx) in two groups of subjects.\n\nPatients must be submitted to the ICU and be endotracheally intubated and receiving mechanical ventilation with continuous IV sedation for less than 24 hours after recruitment into the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Admitted to Duke University Neuro Critical Care Unit (NCCU)\n* Adult (18 years of age or older)\n* Expected Mechanical Ventilation for \\>48 hours with sedation\n* Intraventricular catheter in situ\n\nExclusion Criteria:\n\n* Hypersensitivity to study drugs\n* Prisoners\n* Moribund state or death expected within 24 hours\n* Surgery planned within 24 hours of subject enrollment\n* Receiving study drug, Precedex, prior to entering study'}, 'identificationModule': {'nctId': 'NCT01169467', 'acronym': 'C3PO', 'briefTitle': 'Cerebral Perfusion Pressure Using Precedex and Other Sedatives', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'Cerebral Perfusion Pressure Using Precedex and Other Sedatives', 'orgStudyIdInfo': {'id': 'Pro00018317'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standard-of-Care plus Precedex', 'description': 'Subjects who are treated with dexmedetomidine (Precedex) in addition to the standard of care sedation regiment.', 'interventionNames': ['Drug: Standard-of-Care plus Dexmedetomidine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Standard-of-Care', 'description': 'Subjects who are treated with the standard of care sedation regiment only.', 'interventionNames': ['Other: Standard-of-Care']}], 'interventions': [{'name': 'Standard-of-Care plus Dexmedetomidine', 'type': 'DRUG', 'otherNames': ['Precedex'], 'description': 'Subjects who are treated with dexmedetomidine (Precedex) in addition to the standard of care sedation regiment', 'armGroupLabels': ['Standard-of-Care plus Precedex']}, {'name': 'Standard-of-Care', 'type': 'OTHER', 'description': 'Subjects who are treated with the standard of care sedation regiment only.', 'armGroupLabels': ['Standard-of-Care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Medical Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}], 'overallOfficials': [{'name': 'Keith Dombrowski, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hospira, now a wholly owned subsidiary of Pfizer', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}