Blood Pressure Management on Cardiovascular AdveRse Events After Major Abdominal Surgery

  • STATUS
    Recruiting
  • End date
    Jun 5, 2025
  • participants needed
    1500
  • sponsor
    Nanfang Hospital of Southern Medical University
Updated on 19 February 2024
diabetes
stroke
hypertension
heart failure
coronary artery disease
blood pressure management
abdominal surgery
troponin
peripheral vascular disease

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.

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.

Details
Condition Cardiovascular Complication
Age 45years - 100years
Treatment Intensive intraoperative blood pressure management, Conventional intraoperative blood pressure management
Clinical Study IdentifierNCT04430920
SponsorNanfang Hospital of Southern Medical University
Last Modified on19 February 2024

Eligibility

Yes No Not Sure

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 >133mol/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
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