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| Name | Class |
|---|---|
| Xinqiao Hospital of Chongqing | OTHER |
| Henan Provincial People's Hospital | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intensive intraoperative blood pressure management | Active Comparator |
| |
| Conventional intraoperative blood pressure management | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intensive intraoperative blood pressure management | Other | Targeting intraoperative mean arterial pressure ≥ 80 mmHg. |
|
| 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 |
| 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 |
| Measure | Description | 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bingcheng Zhao, MD | Nanfang Hospital, Southern Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xinqiao Hospital of Chongqing | Chongqing | Chongqing Municipality | 400037 | China | ||
| Southern Medical University Nanfang Hospital |
The deidentified IPD will be shared upon reasonable request after study completion.
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| Conventional intraoperative blood pressure management | Other | Targeting intraoperative mean arterial pressure ≥ 65 mmHg or 60% of the baseline level (use the higher target). |
|
| 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 |
| Guangzhou |
| China |
| Henan Provincial People's Hospital | Zhengzhou | China |