Impact of Intraoperative Hemodynamic Instability on Outcomes in Cardiac Surgery

NCT07324694 · tracked via the Priya Life Science Turkey tracker

Sponsor

Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

Phase

Observational

Started

2025-04-26

Last updated

2026-09-04

Condition(s) studied

Cardiac SurgeryIntraoperative Hemodynamic InstabilityPostoperative ComplicationAcute Kidney InjuryPostoperative Delirium (POD)

Study summary

Intraoperative hemodynamic instability (IOHI) is a common occurrence during cardiac surgery and is associated with organ hypoperfusion. However, the specific impact of IOHI on composite adverse outcomes remains unclear. This prospective cohort study aims to evaluate the association between intraoperative hemodynamic instability (defined as MAP \< 65 mmHg or vasopressor requirement) and major postoperative complications (Delirium, Acute Kidney Injury, Stroke, or Mortality) in adult patients undergoing elective cardiac surgery with cardiopulmonary bypass.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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.

Primary outcome measure(s)

Incidence of Composite Adverse Events — Up to 30 days post-operation
A composite endpoint defined as the occurrence of any of the following within 30 days post-surgery: Postoperative Delirium (assessed by CAM-ICU), Acute Kidney Injury (KDIGO criteria stage 1 or higher), Stroke (new neurological deficit confirmed by imaging), or All-cause Mortality.

Trial sites (1)

Facility	City	Region	Status
Gazi Yaşargil Training and Research Hospital	Diyarbakır	Diyarbakır	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07324694 on ClinicalTrials.gov ↗ ← All trials in Turkey