Blood Pressure Management on Cardiovascular AdveRse Events After Major Abdominal Surgery

NCT04430920 | Completed DMC

• 1 other identifier: NFEC-2019-261
• Study Type: interventional
• Target: 1,500
• Locations: 1 country
• Sites: 3

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.

Conditions

Cardiovascular Complication

Keywords

Intraoperative blood pressure; Major abdominal surgery; Cardiovascular complication

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Number of participants with non-cardiovascular complications

  30-day after surgery

• Days alive and at home

  30-day after surgery

• Number of participants who died or developed disability

  180-day after surgery

Other Outcomes (2)

• 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

Study Arms (2)

Intensive intraoperative blood pressure management

ACTIVE COMPARATOR

Other: Intensive intraoperative blood pressure management

Conventional intraoperative blood pressure management

PLACEBO COMPARATOR

Other: Conventional intraoperative blood pressure management

Interventions

Intensive intraoperative blood pressure management OTHER

Targeting intraoperative mean arterial pressure ≥ 80 mmHg.

Intensive intraoperative blood pressure management

Conventional intraoperative blood pressure management OTHER

Targeting intraoperative mean arterial pressure ≥ 65 mmHg or 60% of the baseline level (use the higher target).

Conventional intraoperative blood pressure management

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University: lead
• Xinqiao Hospital of Chongqing: collaborator
• Henan Provincial People's Hospital: collaborator

Study Sites (3)

Xinqiao Hospital of Chongqing

Chongqing, Chongqing Municipality, 400037, China

Location

Southern Medical University Nanfang Hospital

Guangzhou, China

Location

Henan Provincial People's Hospital

Zhengzhou, China

Location

Study Officials

• Bingcheng Zhao, MD

  Nanfang Hospital, Southern Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2020
• First Posted: June 16, 2020
• Study Start: June 30, 2020
• Primary Completion: September 23, 2022
• Study Completion: April 8, 2025
• Last Updated: April 22, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share

Locations

CN (3)