Ignite Creation Date:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2026-03-14 @ 4:11 AM
Study NCT ID:
NCT04430920
Status:
COMPLETED
Last Update Posted:
2025-04-22
First Post:
2020-06-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Blood Pressure Management on Cardiovascular AdveRse Events After Major Abdominal Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1500}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-06-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2025-04-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-20', 'studyFirstSubmitDate': '2020-06-11', 'studyFirstSubmitQcDate': '2020-06-11', 'lastUpdatePostDateStruct': {'date': '2025-04-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'For patients receiving radical cancer resection: overall survival', 'timeFrame': '3-year after surgery'}, {'measure': 'For patients receiving radical cancer resection: disease-free survival', 'timeFrame': '3-year after surgery'}], 'primaryOutcomes': [{'measure': 'Number of participants with major adverse cardiac events', 'timeFrame': '30-day after surgery', 'description': 'A composite of myocardial injury/infarction, new-onset clinically important arrhythmia, heart failure, stroke, cardiac arrest, and all-cause death after surgery'}], 'secondaryOutcomes': [{'measure': 'Number of participants with non-cardiovascular complications', 'timeFrame': '30-day after surgery', 'description': 'Postoperative acute kidney injury, infection, pulmonary complications, delirium, gastrointestinal complications (GI infarction, bleeding, perforation, obstruction), venous thromboembolism, anastomotic fistula, bleed requiring transfusion'}, {'measure': 'Days alive and at home', 'timeFrame': '30-day after surgery'}, {'measure': 'Number of participants who died or developed disability', 'timeFrame': '180-day after surgery', 'description': 'Disability is assessed based on 12-item WHO Disability Assessment Schedule (WHODAS 2.0)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Intraoperative blood pressure', 'Major abdominal surgery', 'Cardiovascular complication'], 'conditions': ['Cardiovascular Complication']}, 'descriptionModule': {'briefSummary': 'This study is a multicenter randomized controlled trial comparing an intensive intraoperative blood pressure management strategy versus conventional practice for preventing cardiovascular events in high-risk patients undergoing major abdominal surgery.', 'detailedDescription': 'Intraoperative hypotension has been associated with cardiovascular events after non-cardiac surgery. However, whether avoiding intraoperative hypotension can reduce the incidence of postoperative cardiovascular events remains unclear. The objective of this study is to assess the effects of an intensive intraoperative blood pressure management strategy (to maintain intraoperative MAP ≥ 80mmHg) with that of conventional practice (to maintain intraoperative MAP ≥ 65mmHg) on the incidence of cardiovascular events after major abdominal surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Aged ≥ 45 years;\n2. Undergoing major abdominal surgery under general anesthesia (expected surgery time \\>2h, expected length of postoperative stay \\>2d);\n3. Fulfill ≥1 of the following criteria (a-f): a. history of coronary artery disease; b. history of stroke; c. history of peripheral arterial disease; d. history of congestive heart failure; e. preoperative NT-proBNP \\>200 pg/mL or BNP \\>92 mg/L f. preoperative troponin \\> upper limit of normal; or fulfill ≥2 of the following criteria (g-l); g. history of chronic kidney disease (preoperative sCr \\>133μmol/L or 1.5 mg/dL); h. diabetes requiring medical treatment; i. smoking in the past \\>2 years; j.≥ 65 years of age; k. hypertension requiring medical treatment l. history of hypercholesterolemia.\n\nExclusion Criteria:\n\n1. ASA score ≥5;\n2. Severe untreated or uncontrolled hypertension (preoperative SBP\\>180mmHg and/or DBP\\>110mmHg);\n3. End-stage renal disease requiring renal-replacement therapy;\n4. Acute cardiovascular event within 1 month of surgery, including acute heart failure, acute coronary syndrome and stroke;\n5. Preoperative sepsis or septic shock;\n6. Preoperative requirement of vasopressor infusion;\n7. Current participation in another interventional study;\n8. Previous participation in this study;\n9. Pregnant or breastfeeding women.'}, 'identificationModule': {'nctId': 'NCT04430920', 'acronym': 'BP-CARES', 'briefTitle': 'Blood Pressure Management on Cardiovascular AdveRse Events After Major Abdominal Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Nanfang Hospital, Southern Medical University'}, 'officialTitle': 'Blood Pressure Management on Cardiovascular AdveRse Events After Major Abdominal Surgery (BP-CARES): A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'NFEC-2019-261'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Intensive intraoperative blood pressure management', 'interventionNames': ['Other: Intensive intraoperative blood pressure management']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Conventional intraoperative blood pressure management', 'interventionNames': ['Other: Conventional intraoperative blood pressure management']}], 'interventions': [{'name': 'Intensive intraoperative blood pressure management', 'type': 'OTHER', 'description': 'Targeting intraoperative mean arterial pressure ≥ 80 mmHg.', 'armGroupLabels': ['Intensive intraoperative blood pressure management']}, {'name': 'Conventional intraoperative blood pressure management', 'type': 'OTHER', 'description': 'Targeting intraoperative mean arterial pressure ≥ 65 mmHg or 60% of the baseline level (use the higher target).', 'armGroupLabels': ['Conventional intraoperative blood pressure management']}]}, 'contactsLocationsModule': {'locations': [{'zip': '400037', 'city': 'Chongqing', 'state': 'Chongqing Municipality', 'country': 'China', 'facility': 'Xinqiao Hospital of Chongqing', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}, {'city': 'Guangzhou', 'country': 'China', 'facility': 'Southern Medical University Nanfang Hospital', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'city': 'Zhengzhou', 'country': 'China', 'facility': "Henan Provincial People's Hospital", 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}], 'overallOfficials': [{'name': 'Bingcheng Zhao, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Nanfang Hospital, Southern Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'The deidentified IPD will be shared upon reasonable request after study completion.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nanfang Hospital, Southern Medical University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Xinqiao Hospital of Chongqing', 'class': 'OTHER'}, {'name': 'Henan Provincial People's Hospital', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}