Blood Pressure Management on Cardiovascular AdveRse Events After Major Abdominal Surgery

Not Applicable

Completed

• Conditions: Cardiovascular Complication
• Interventions: Other: Intensive intraoperative blood pressure management; Other: Conventional intraoperative blood pressure management

• Registration Number: NCT04430920
• Lead Sponsor: Nanfang Hospital, Southern Medical University

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2020-06-11
• Study First Submitted QC: 2020-06-11
• Study First Posted: 2020-06-16
• Study Start: 2020-06-30
• Primary Completion: 2022-09-23
• Status Verified: 2025-04
• Study Completion: 2025-04-08
• Last Update Submitted: 2025-04-20
• Last Update Posted: 2025-04-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1500

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intensive intraoperative blood pressure management	Intensive intraoperative blood pressure management	-
Conventional intraoperative blood pressure management	Conventional intraoperative blood pressure management	-

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (3)

Xinqiao Hospital of Chongqing; 🇨🇳 Chongqing, Chongqing, China

Southern Medical University Nanfang Hospital; 🇨🇳 Guangzhou, China

Henan Provincial People's Hospital; 🇨🇳 Zhengzhou, China