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

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ClinicalTrials.gov Identifier: NCT04430920
Recruitment Status : Recruiting
First Posted : June 16, 2020
Last Update Posted : August 4, 2020
Sponsor:
Collaborators:
Xinqiao Hospital of Chongqing
Henan Provincial People's Hospital
Information provided by (Responsible Party):
Nanfang Hospital of Southern Medical University

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.

Condition or disease Intervention/treatment Phase
Cardiovascular Complication Other: Intensive intraoperative blood pressure management Other: Conventional intraoperative blood pressure management Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Blood Pressure Management on Cardiovascular AdveRse Events After Major Abdominal Surgery (BP-CARES): A Randomized Controlled Trial
Actual Study Start Date : June 30, 2020
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : June 2025

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).




Primary Outcome Measures :
  1. Number of participants with major adverse cardiac events [ Time Frame: 30-day after surgery ]
    A composite of myocardial injury/infarction, new-onset clinically important arrhythmia, heart failure, stroke, cardiac arrest, and all-cause death after surgery


Secondary Outcome Measures :
  1. Number of participants with non-cardiovascular complications [ Time Frame: 30-day after surgery ]
    Postoperative acute kidney injury, infection, pulmonary complications, delirium, gastrointestinal complications (GI infarction, bleeding, perforation, obstruction), venous thromboembolism, anastomotic fistula, bleed requiring transfusion

  2. Days alive and at home [ Time Frame: 30-day after surgery ]
  3. Number of participants who died or developed disability [ Time Frame: 180-day after surgery ]
    Disability is assessed based on 12-item WHO Disability Assessment Schedule (WHODAS 2.0)


Other Outcome Measures:
  1. For patients receiving radical cancer resection: overall survival [ Time Frame: 3-year after surgery ]
  2. For patients receiving radical cancer resection: disease-free survival [ Time Frame: 3-year after surgery ]


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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04430920


Contacts
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Contact: Bingcheng Zhao, MD +8613763313653 zhaobch@mail2.sysu.edu.cn

Locations
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China
Xinqiao Hospital of Chongqing Recruiting
Chongqing, China
Southern Medical University Nanfang Hospital Recruiting
Guangzhou, China
Henan Provincial People's Hospital Recruiting
Zhengzhou, China
Sponsors and Collaborators
Nanfang Hospital of Southern Medical University
Xinqiao Hospital of Chongqing
Henan Provincial People's Hospital
Investigators
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Principal Investigator: Bingcheng Zhao, MD Nanfang Hospital of Southern Medical University
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Responsible Party: Nanfang Hospital of Southern Medical University
ClinicalTrials.gov Identifier: NCT04430920    
Other Study ID Numbers: NFEC-2019-261
First Posted: June 16, 2020    Key Record Dates
Last Update Posted: August 4, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The deidentified IPD will be shared upon reasonable request after study completion.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nanfang Hospital of Southern Medical University:
Intraoperative blood pressure
Major abdominal surgery
Cardiovascular complication