Blood Pressure Management on Cardiovascular AdveRse Events After Major Abdominal Surgery (BP-CARES)

Nanfang Hospital, Southern Medical University

Status: Active, not recruiting

Conditions: Cardiovascular Complication

Treatments: Other: Intensive intraoperative blood pressure management; Other: Conventional intraoperative blood pressure management

Study type: Interventional

Funder types: Other

Identifiers

NCT04430920

NFEC-2019-261

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 1,500 estimated patients

Sex: All

Ages: 45+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Aged ≥ 45 years;
2. Undergoing major abdominal surgery under general anesthesia (expected surgery time >2h, expected length of postoperative stay >2d);
3. 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

1. ASA score ≥5;
2. Severe untreated or uncontrolled hypertension (preoperative SBP>180mmHg and/or DBP>110mmHg);
3. End-stage renal disease requiring renal-replacement therapy;
4. Acute cardiovascular event within 1 month of surgery, including acute heart failure, acute coronary syndrome and stroke;
5. Preoperative sepsis or septic shock;
6. Preoperative requirement of vasopressor infusion;
7. Current participation in another interventional study;
8. Previous participation in this study;
9. Pregnant or breastfeeding women.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,500 participants in 2 patient groups, including a placebo group

Intensive intraoperative blood pressure management

Active Comparator group

Treatment:

Other: Intensive intraoperative blood pressure management

Conventional intraoperative blood pressure management

Placebo Comparator group

Treatment:

Other: Conventional intraoperative blood pressure management