Blood Pressure Management on Cardiovascular AdveRse Events After Major Abdominal Surgery

Cardiovascular Complication Clinical Trial

— BP-CARES  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04430920
• Other study ID #: NFEC-2019-261
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 30, 2020
• Est. completion date: March 2025

Study information

• Verified date: April 2023
• Source: Nanfang Hospital of Southern Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1500
• Est. completion date: March 2025
• Est. primary completion date: September 23, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cardiovascular Complication

Intervention

Other:
• Intensive intraoperative blood pressure management
Targeting intraoperative mean arterial pressure = 80 mmHg.
• Conventional intraoperative blood pressure management
Targeting intraoperative mean arterial pressure = 65 mmHg or 60% of the baseline level (use the higher target).

Locations

Country	Name	City	State
China	Xinqiao Hospital of Chongqing	Chongqing	Chongqing
China	Southern Medical University Nanfang Hospital	Guangzhou
China	Henan Provincial People's Hospital	Zhengzhou

Sponsors (3)

Lead Sponsor	Collaborator
Nanfang Hospital of Southern Medical University	Henan Provincial People's Hospital, Xinqiao Hospital of Chongqing

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	For patients receiving radical cancer resection: overall survival		3-year after surgery
Other	For patients receiving radical cancer resection: disease-free survival		3-year after surgery
Primary	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	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
Secondary	Days alive and at home		30-day after surgery
Secondary	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