Blood Pressure Management on Cardiovascular AdveRse Events After Major Abdominal Surgery (BP-CARES)

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Cardiovascular Complication
• Intervention / Treatment: Other: Intensive intraoperative blood pressure management; Other: Conventional intraoperative blood pressure management

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 Type: Interventional
• Enrollment (Anticipated): 1500
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guangzhou, China
    • Southern Medical University Nanfang Hospital
  • Zhengzhou, China
    • Henan Provincial People's Hospital
  • Chongqing
    • Chongqing, Chongqing, China, 400037
      • Xinqiao Hospital of Chongqing

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Intensive intraoperative blood pressure management	Other: Intensive intraoperative blood pressure management; Targeting intraoperative mean arterial pressure ≥ 80 mmHg.
Placebo Comparator: Conventional intraoperative blood pressure management	Other: Conventional intraoperative blood pressure management; Targeting intraoperative mean arterial pressure ≥ 65 mmHg or 60% of the baseline level (use the higher target).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	30-day after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	30-day after surgery
Days alive and at home		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)	180-day after surgery

Other Outcome Measures

Outcome Measure	Time Frame
For patients receiving radical cancer resection: overall survival	3-year after surgery
For patients receiving radical cancer resection: disease-free survival	3-year after surgery

Collaborators and Investigators

• Sponsor: Nanfang Hospital of Southern Medical University
• Collaborators: Henan Provincial People's Hospital; Xinqiao Hospital of Chongqing
• Investigators: Principal Investigator: Bingcheng Zhao, MD, Nanfang Hospital of Southern Medical University

Study record dates

Study Major Dates

• Study Start (Actual): June 30, 2020
• Primary Completion (Actual): September 23, 2022
• Study Completion (Anticipated): March 1, 2025

Study Registration Dates

• First Submitted: June 11, 2020
• First Submitted That Met QC Criteria: June 11, 2020
• First Posted (Actual): June 16, 2020

Study Record Updates

• Last Update Posted (Actual): April 7, 2023
• Last Update Submitted That Met QC Criteria: April 6, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Major abdominal surgery; Intraoperative blood pressure; Cardiovascular complication
• Other Study ID Numbers: NFEC-2019-261

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The deidentified IPD will be shared upon reasonable request after study completion.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No