Blood Pressure Management on Cardiovascular AdveRse Events After Major Abdominal Surgery

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Blood Pressure Management on Cardiovascular AdveRse Events After Major Abdominal Surgery (BP-CARES): A Randomized Controlled Trial

Conditions
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Cardiovascular Complication

Intervention / Treatment
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* Other: Intensive intraoperative blood pressure management
* Other: Conventional intraoperative blood pressure management


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged ≥ 45 years; Undergoing major abdominal surgery under general anesthesia (expected surgery time >2h, expected length of postoperative stay >2d); 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. Exclusion Criteria: ASA score ≥5; Severe untreated or uncontrolled hypertension (preoperative SBP>180mmHg and/or DBP>110mmHg); End-stage renal disease requiring renal-replacement therapy; Acute cardiovascular event within 1 month of surgery, including acute heart failure, acute coronary syndrome and stroke; Preoperative sepsis or septic shock; Preoperative requirement of vasopressor infusion; Current participation in another interventional study; Previous participation in this study; Pregnant or breastfeeding women.

Ages Eligible for Study
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Minimum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intensive intraoperative blood pressure management<br> | Other: Intensive intraoperative blood pressure management<br>* Targeting intraoperative mean arterial pressure ≥ 80 mmHg.<br>|
| Placebo Comparator: Conventional intraoperative blood pressure management<br> | Other: Conventional intraoperative blood pressure management<br>* Targeting intraoperative mean arterial pressure ≥ 65 mmHg or 60% of the baseline level (use the higher target).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with major adverse cardiac events | A composite of myocardial injury/infarction, new-onset clinically important arrhythmia, heart failure, stroke, cardiac arrest, and all-cause death after surgery | 30-day after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with non-cardiovascular complications | Postoperative acute kidney injury, infection, pulmonary complications, delirium, gastrointestinal complications (GI infarction, bleeding, perforation, obstruction), venous thromboembolism, anastomotic fistula, bleed requiring transfusion | 30-day after surgery | 
| Days alive and at home |  | 30-day after surgery | 
| Number of participants who died or developed disability | Disability is assessed based on 12-item WHO Disability Assessment Schedule (WHODAS 2.0) | 180-day after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intraoperative blood pressure, Major abdominal surgery, Cardiovascular complication