How low blood pressure during heart surgery affects recovery

Impact of Intraoperative Hemodynamic Instability on Postoperative Major Adverse Events in Cardiac Surgery Patients: A Prospective Cohort Study

This study tests whether low blood pressure (MAP < 65 mmHg) or needing strong blood pressure drugs during elective adult heart surgery with cardiopulmonary bypass leads to more major problems like delirium, kidney injury, stroke, or death within 30 days.

Quick facts

• Study type: Observational
• Enrollment: 230 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital (other)
• Locations: 1 site (Diyarbakır, Diyarbakır)
• Trial ID: NCT07324694 on ClinicalTrials.gov

What this trial studies

This is a prospective observational cohort of adults undergoing elective coronary bypass, valve, or combined heart surgery with cardiopulmonary bypass at a single academic center. Intraoperative hemodynamic data (MAP, heart rate, vasoactive medication use) will be recorded and patients classified as hemodynamically unstable (MAP < 65 mmHg for >5 continuous minutes or requiring significant vasopressors/inotropes) or stable. The primary endpoint is a 30-day composite of postoperative delirium (CAM-ICU), acute kidney injury (KDIGO), stroke, or all-cause mortality, with secondary endpoints including duration of mechanical ventilation and ICU/hospital length of stay. The goal is to clarify whether specific intraoperative blood pressure patterns are associated with worse outcomes and to inform intraoperative MAP targets.

Who should consider this trial

Good fit: Adults (age ≥18) scheduled for elective CABG, valve repair/replacement, or combined procedures under cardiopulmonary bypass with preoperative sinus rhythm who can give informed consent.

Not a fit: Patients undergoing emergency or salvage operations, off-pump procedures, those on preoperative mechanical circulatory support, chronic dialysis, or with pre-existing cognitive impairment are excluded and may not benefit from the findings.

Why it matters

Potential benefit: If successful, the results could lead to clearer blood pressure targets during surgery that reduce rates of delirium, acute kidney injury, stroke, and death after cardiac surgery.

How similar studies have performed: Prior observational studies have linked intraoperative hypotension to acute kidney injury and mortality, but optimal MAP thresholds and effects on a composite outcome including delirium and stroke remain unclear.

Eligibility criteria

Inclusion Criteria:

* Patients aged 18 years or older.
* Scheduled for elective cardiac surgery (CABG, Valve replacement/repair, or combined procedures).
* Surgery performed under cardiopulmonary bypass (CPB).
* Preoperative sinus rhythm.
* Signed informed consent form.

Exclusion Criteria:

* Emergency or salvage surgery.
* Off-pump coronary artery bypass grafting.
* Preoperative mechanical circulatory support (IABP, ECMO) requirement.
* Pre-existing chronic renal failure requiring dialysis (HD/PD).
* Pre-existing cognitive impairment, dementia, or history of psychiatric disorders affecting cooperation.
* Pregnancy.

Where this trial is running

Diyarbakır, Diyarbakır

• Gazi Yaşargil Training and Research Hospital — Diyarbakır, Diyarbakır, Turkey (Türkiye) (RECRUITING)

Study contacts

• Study coordinator: Osman Uzundere, M.D.

Conditions: Cardiac Surgery, Intraoperative Hemodynamic Instability, Postoperative Complication, Acute Kidney Injury, Postoperative Delirium, Intraoperative Hypotension, Cardiopulmonary Bypass, Mean Arterial Pressure