Blood Pressure Management on Cardiovascular AdveRse Events After Major Abdominal Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-30

Study Completion Date

2025-04-08

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.

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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.

Conditions

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Cardiovascular Complication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Intensive intraoperative blood pressure management

Group Type ACTIVE_COMPARATOR

Intensive intraoperative blood pressure management

Intervention Type OTHER

Targeting intraoperative mean arterial pressure ≥ 80 mmHg.

Conventional intraoperative blood pressure management

Group Type PLACEBO_COMPARATOR

Conventional intraoperative blood pressure management

Intervention Type OTHER

Targeting intraoperative mean arterial pressure ≥ 65 mmHg or 60% of the baseline level (use the higher target).

Interventions

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Intensive intraoperative blood pressure management

Targeting intraoperative mean arterial pressure ≥ 80 mmHg.

Intervention Type OTHER

Conventional intraoperative blood pressure management

Targeting intraoperative mean arterial pressure ≥ 65 mmHg or 60% of the baseline level (use the higher target).

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No