Status:
COMPLETED
Blood Pressure Management on Cardiovascular AdveRse Events After Major Abdominal Surgery
Lead Sponsor:
Nanfang Hospital, Southern Medical University
Collaborating Sponsors:
Xinqiao Hospital of Chongqing
Henan Provincial People's Hospital
Conditions:
Cardiovascular Complication
Eligibility:
All Genders
45+ years
Phase:
NA
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 hi...
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 card...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 30 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 8 2025
Estimated Enrollment :
1500 Patients enrolled
Trial Details
Trial ID
NCT04430920
Start Date
June 30 2020
End Date
April 8 2025
Last Update
April 22 2025
Active Locations (3)
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1
Xinqiao Hospital of Chongqing
Chongqing, Chongqing Municipality, China, 400037
2
Southern Medical University Nanfang Hospital
Guangzhou, China
3
Henan Provincial People's Hospital
Zhengzhou, China