Clinical trial NCT04430920: Blood Pressure Management on Cardiovascular AdveRse Events After Major Abdominal Surgery
Official title: Blood Pressure Management on Cardiovascular AdveRse Events After Major Abdominal Surgery (BP-CARES): A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Complication
Keywords: Intraoperative blood pressure
Major abdominal surgery
Cardiovascular complication
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
Collaborators: name: Xinqiao Hospital of Chongqing
name: Henan Provincial People&#39;s Hospital
First posted: 2020-06-16
Enrollment: 1500
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of participants with major adverse cardiac events
timeFrame: 30-day after surgery
Secondary outcomes:
measure: Number of participants with non-cardiovascular complications
timeFrame: 30-day after surgery
measure: Days alive and at home
timeFrame: 30-day after surgery
measure: Number of participants who died or developed disability
timeFrame: 180-day after surgery
Other outcomes:
measure: For patients receiving radical cancer resection: overall survival
timeFrame: 3-year after surgery
measure: For patients receiving radical cancer resection: disease-free survival
timeFrame: 3-year after surgery
Locations:
city: Chongqing
country: China
facility: Xinqiao Hospital of Chongqing
state: Chongqing
city: Guangzhou
country: China
facility: Southern Medical University Nanfang Hospital
city: Zhengzhou
country: China
facility: Henan Provincial People's Hospital
Study officials:
affiliation: Nanfang Hospital, Southern Medical University
name: Bingcheng Zhao, MD
role: PRINCIPAL_INVESTIGATOR
References: