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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
1,500
Targeting intraoperative mean arterial pressure ≥ 80 mmHg.
Targeting intraoperative mean arterial pressure ≥ 65 mmHg or 60% of the baseline level (use the higher target).
Xinqiao Hospital of Chongqing
Chongqing, Chongqing Municipality, China
Southern Medical University Nanfang Hospital
Guangzhou, China
Henan Provincial People's Hospital
Zhengzhou, China
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
Time frame: 30-day after surgery
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
Time frame: 30-day after surgery
Days alive and at home
Time frame: 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)
Time frame: 180-day after surgery
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