Ignite Creation Date:
2025-12-26 @ 12:19 PM
Ignite Modification Date:
2026-03-04 @ 4:43 AM
Study NCT ID:
NCT04197700
Status:
COMPLETED
Last Update Posted:
2024-09-19
First Post:
2019-12-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The PRESSURE CABG Cardiac Surgery Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007022', 'term': 'Hypotension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Pragmatic, prospective, single-center, unit-based cluster crossover, open-label registry'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 600}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2024-05-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-12', 'studyFirstSubmitDate': '2019-12-03', 'studyFirstSubmitQcDate': '2019-12-11', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-12-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Composite of delirium or AKI', 'timeFrame': 'within 7 days of surgery', 'description': 'composite of delirium(defined as Intensive care delirium screening checklist score \\>=4) or Acute kidney injury (defined as a \\>=50% rise in serum creatinine)m'}, {'measure': 'Re-operation for bleeding', 'timeFrame': 'Within 7 days of surgery', 'description': 're-operation for bleeding'}], 'secondaryOutcomes': [{'measure': 'Delirium', 'timeFrame': 'Through 7 days', 'description': 'Incidence (defined as Intensive care delirium screening checklist score \\>=4) and duration of Delirium (in days)'}, {'measure': 'The incidence of Stroke', 'timeFrame': 'Up to the time of hospital discharge, estimated average 5 days', 'description': 'post-operative stroke'}, {'measure': 'Renal Outcomes', 'timeFrame': 'Up to the time of hospital discharge, estimated average 5 days', 'description': 'Risk of Acute kidney injury, Acute Kidney Injury, Renal Failure, Renal replacement therapy according to RIFLE criteria'}, {'measure': 'Difference in peak median creatinine levels', 'timeFrame': 'Up to the time of hospital discharge, estimated average 5 days', 'description': 'Absolute difference in peak median creatinine levels'}, {'measure': 'Chest tube output', 'timeFrame': 'Through 48 hours post-op', 'description': 'Median differences in chest tube output'}, {'measure': 'Blood Products', 'timeFrame': 'Through 48 hours post-operatively', 'description': 'Number of red blood cell, fresh frozen plasma, and platelet transfusions'}, {'measure': 'IV Vasoactive Support', 'timeFrame': 'Up to the time of ICU discharge, , estimated average 2 days', 'description': 'Median duration of intravenous vasoactive support'}, {'measure': 'Vasoactive support >24hrs', 'timeFrame': 'Up to 25 hours post-operatively', 'description': 'Percentage of patients with vasoactive support \\>24 hours'}, {'measure': 'Mechanical Ventilation', 'timeFrame': 'Up to the time of ICU discharge, estimated average 4 hours', 'description': 'Duration of mechanical ventilation'}, {'measure': 'Length of Stay', 'timeFrame': 'Up to the time of ICU discharge, estimated average 2 days', 'description': 'Duration of CSICU stay'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Coronary Artery Bypass Grafting', 'Hypotension']}, 'descriptionModule': {'briefSummary': 'This study will be a pragmatic, prospective, single-centre, unit-based cluster crossover, open-label registry trial. The cardiac surgical intensive care unit (CSICU) will be cluster assigned to alternating MAP targets in 6-month blocks in a sequence. Additional sites across Alberta may be added, as necessary.', 'detailedDescription': 'Personalized Arm: The target MAP will be defined as +10% of the resting MAP. Resting MAP will be defined in priority order using one of the following MAP measurements:\n\n* Pre-operative anesthesia or surgical consultation;\n* Other physician outpatient consultation (e.g. cardiology, family physician, internist) within 30 days of surgery;\n* Inpatient measurement the night before surgery;\n* Pre-anesthetic MAP\n\nThe lower and upper safety limits of personalized MAP targets will be 50mmHg and \\<90mmHg, respectively.\n\nProtocolized Arm: The target MAP will be defined as 65 +/- 5mmHg. Pharmacologic and fluid treatment decisions will be at the discretion of the most responsible physician.\n\nIn both study arms, the blood pressure control period will extend from anesthetic induction until 12 hours after admission to the CSICU. As an additional safety metric, the anesthesiologist will be encouraged to utilize clinically-driven cerebral saturation monitoring to identify potential hypoperfusion. In cases with low bilateral saturations where the anesthesiologist feels low MAP may be the putative mechanism, the investigators will request that MAPs be raised in 5mmHg increments. Following completion of the study protocol, the MAP and/or systolic blood pressure targets will be at the discretion of the most responsible physician.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients \\> or = to 18 years of age undergoing non-emergent CABG\n\nExclusion Criteria:\n\n* Pre-induction use of intravenous inotrope, vasopressor, or vasodilator\n* Re-operation during the index hospital stay\n* Non-CABG valvular or aortic surgery\n* \\*Patients with end-stage renal disease or pre-operative AKI (defined as in-hospital increase in creatinine by \\>50%) will be excluded from the renal outcomes but included in the analysis of secondary outcomes'}, 'identificationModule': {'nctId': 'NCT04197700', 'acronym': 'PRESSURECABG', 'briefTitle': 'The PRESSURE CABG Cardiac Surgery Trial', 'organization': {'class': 'OTHER', 'fullName': 'University of Alberta'}, 'officialTitle': 'PRotocolized vs pErsonalized Blood preSSUre peRi-operative paramEters in Coronary Artery Bypass Grafting Surgery: The PRESSURE CABG Cardiac Surgery Trial', 'orgStudyIdInfo': {'id': 'Pro00095074'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Personalized Arm', 'description': 'Personalized Arm: The target MAP will be defined as +/- 5% of the resting MAP. Resting MAP will be defined in priority order using one of the following MAP measurements:\n\n* Pre-operative anesthesia or surgical consultation;\n* Other physician outpatient consultation (e.g. cardiology, family physician, internist) within 30 days of surgery;\n* Inpatient measurement the night before surgery;\n* Pre-anesthetic MAP\n\nThe order of the measurements prioritizes outpatient MAPs given that temporary pre-operative discontinuation of anti-hypertensive agents could potentially raise, while fasting and/or fluid restriction pre-operatively could potentially lower resting blood pressure.39 The lower and upper safety limits of personalized MAP targets will be 50mmHg and \\<90mmHg, respectively.', 'interventionNames': ['Other: Target MAP Management']}, {'type': 'OTHER', 'label': 'Protocolized Arm', 'description': 'Protocolized Arm: The target MAP will be defined as 65 +/- 5mmHg. Pharmacologic and fluid treatment decisions will be at the discretion of the most responsible physician.\n\nIn both study arms, the blood pressure control period will extend from anesthetic induction until 12 hours after admission to the CSICU. As an additional safety metric, the anesthesiologist will be encouraged to utilize clinically-driven cerebral saturation monitoring to identify potential hypoperfusion. In cases with low bilateral saturations where the anesthesiologist feels low MAP may be the putative mechanism, the investigators will request that MAPs be raised in 5mmHg increments. Following completion of the study protocol, the MAP and/or systolic blood pressure targets will be at the discretion of the most responsible physician.', 'interventionNames': ['Other: Target MAP Management']}], 'interventions': [{'name': 'Target MAP Management', 'type': 'OTHER', 'description': 'Target MAP Management', 'armGroupLabels': ['Personalized Arm', 'Protocolized Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'T6G 2B7', 'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'facility': 'University of Alberta Hospital', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}], 'overallOfficials': [{'name': 'Sean van Diepen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Alberta'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Alberta', 'class': 'OTHER'}, 'collaborators': [{'name': 'Canadian VIGOUR Centre', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}