Cardiovascular ComplicationBP-CARESNCT04430920

Blood Pressure Management on Cardiovascular AdveRse Events After Major Abdominal Surgery

A study testing Intensive intraoperative blood pressure management and Conventional intraoperative blood pressure management in people with Cardiovascular Complication, run by Nanfang Hospital, Southern Medical University at 3 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 45 years and older
Conditions the study is for: Cardiovascular Complication
What is being tested?: Intensive intraoperative blood pressure management and Conventional intraoperative blood pressure management
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 1,500 participants
Where: 3 sitesChina
Study dates: 30 Jun 2020to 8 Apr 2025
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 45 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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;

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Current participation in another interventional study;
Previous participation in this study;
Pregnant or breastfeeding women.

Trial locations and contacts

3 sites in 1 country.

China3 sites

Xinqiao Hospital of Chongqing
Chongqing, Chongqing Municipality, 400037
Southern Medical University Nanfang Hospital
Guangzhou
Henan Provincial People's Hospital
Zhengzhou

Other trials in China

About this study

Official title: Blood Pressure Management on Cardiovascular AdveRse Events After Major Abdominal Surgery (BP-CARES): A Randomized Controlled Trial

Read the 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.

Conditions: Cardiovascular Complication
Being tested: Intensive intraoperative blood pressure management, Conventional intraoperative blood pressure management
Keywords: Intraoperative blood pressure, Major abdominal surgery, Cardiovascular complication

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Intensive intraoperative blood pressure managementOther
Targeting intraoperative mean arterial pressure ≥ 80 mmHg.
Conventional intraoperative blood pressure managementOther
Targeting intraoperative mean arterial pressure ≥ 65 mmHg or 60% of the baseline level (use the higher target).

Study groups in NCT04430920
Study group	Role	What they receive
Intensive intraoperative blood pressure management	Active comparator	Not described Receives: Other: Intensive intraoperative blood pressure management
Conventional intraoperative blood pressure management	Placebo comparator	Not described Receives: Other: Conventional intraoperative blood pressure management

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 30-day after surgery

Secondary outcomes (3)

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
Measured: 30-day after surgery
Days alive and at home
Measured: 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)
Measured: 180-day after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Jun 20208 Apr 2025

First posted16 Jun 2020
Study start30 Jun 2020
Primary completion23 Sep 2022
Study completion8 Apr 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Cardiovascular ComplicationStudies of the same condition, open and under way.
More trials run by Nanfang Hospital, Southern Medical UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 1,500 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04430920
Sponsor's protocol ID: NFEC-2019-261
Acronym: BP-CARES
Status last verified: Apr 2025
First submitted: 11 Jun 2020
Last updated: 22 Apr 2025
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: The deidentified IPD will be shared upon reasonable request after study completion.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Cardiovascular Complication trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Blood Pressure Management on Cardiovascular AdveRse Events After Major Abdominal Surgery (BP-CARES): A Randomized Controlled Trial
ClinicalTrials.gov ID: NCT04430920
Acronym / sponsor ID: BP-CARES / NFEC-2019-261
Conditions: Cardiovascular Complication
Keywords: Intraoperative blood pressure, Major abdominal surgery, Cardiovascular complication
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,500 participants (actual)
Lead sponsor: Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
Collaborators: Xinqiao Hospital of Chongqing, Hunan Provincial People's Hospital
Study start: 30 Jun 2020 (actual)
Primary completion: 23 Sep 2022 (actual)
Study completion: 8 Apr 2025 (actual)
First posted: 16 Jun 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
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

Who may qualify

Ages: 45 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (9 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Intensive intraoperative blood pressure managementTargeting intraoperative mean arterial pressure ≥ 80 mmHg.	Other	Intensive intraoperative blood pressure management
Conventional intraoperative blood pressure managementTargeting intraoperative mean arterial pressure ≥ 65 mmHg or 60% of the baseline level (use the higher target).	Other	Conventional intraoperative blood pressure management

Primary outcome

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

3 secondary outcomes

Number of participants with non-cardiovascular complications
Time frame: 30-day after surgery
Days alive and at home
Time frame: 30-day after surgery
Number of participants who died or developed disability
Time frame: 180-day after surgery

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2025.
Individual participant dataSharing planned: Yes. The deidentified IPD will be shared upon reasonable request after study completion.

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Recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Bingcheng Zhao, MD principal investigator

Nanfang Hospital, Southern Medical University

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with major adverse cardiac events (time frame: 30-day after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04430920.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2025.