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Completed

NCT Number: NCT04430920

Blood Pressure Management on Cardiovascular AdveRse Events After Major Abdominal Surgery

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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Key information

Age range

45 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Xinqiao Hospital of Chongqing, Chongqing, Chongqing Municipality, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 >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

  • 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.

Treatment and study plan

Intensive intraoperative blood pressure management

Other

Targeting intraoperative mean arterial pressure ≥ 80 mmHg.

Conventional intraoperative blood pressure management

Other

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

Primary outcomes

  1. Number of participants with major adverse cardiac events

    Time frame: 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 outcomes

  1. Number of participants with non-cardiovascular complications

    Time frame: 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

  2. Days alive and at home

    Time frame: 30-day after surgery

  3. Number of participants who died or developed disability

    Time frame: 180-day after surgery

    Disability is assessed based on 12-item WHO Disability Assessment Schedule (WHODAS 2.0)

Other outcomes

  1. For patients receiving radical cancer resection: overall survival

    Time frame: 3-year after surgery

  2. For patients receiving radical cancer resection: disease-free survival

    Time frame: 3-year after surgery

Sponsors and collaborators

Lead sponsor

Nanfang Hospital, Southern Medical University

Other

Collaborators

  • Henan Provincial People's Hospital
  • Xinqiao Hospital of Chongqing

Registry information

Official study title

Blood Pressure Management on Cardiovascular AdveRse Events After Major Abdominal Surgery (BP-CARES): A Randomized Controlled Trial

Acronym: BP-CARES

Important dates

Study start
2020
Primary completion
2022
Study completion
2025
First posted
Jun 16, 2020
Registry last updated
Apr 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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