Acute Kidney Injury, Cardiac Surgery, Intraoperative Hemodynamic Instability, Postoperative Complication, Postoperative Delirium (POD)
Conditions
Keywords
Intraoperative Hypotension, Cardiopulmonary Bypass, Mean Arterial Pressure, Cohort Study
Brief 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.
Detailed description
Hemodynamic instability during cardiac surgery is a critical factor influencing postoperative recovery. While transient hypotension is common, prolonged instability may lead to end-organ damage due to hypoperfusion. This prospective observational study will be conducted at the University of Health Sciences Gazi Yasargil Training and Research Hospital. Patients scheduled for elective cardiac surgery (Coronary Artery Bypass Grafting, Valve replacement/repair, or combined procedures) utilizing cardiopulmonary bypass will be enrolled. Intraoperative hemodynamic data, including Mean Arterial Pressure (MAP), heart rate, and vasoactive medication requirements, will be recorded. Patients will be categorized into two groups based on intraoperative stability: 1. Hemodynamic Instability Group: Patients experiencing MAP \< 65 mmHg for more than 5 minutes continuously or requiring significant vasopressor/inotropic support to maintain target pressure. 2. Stable Group: Patients maintaining hemodynamic stability without significant hypotensive episodes. The primary endpoint is a composite of major adverse events within 30 days, including Postoperative Delirium (assessed via CAM-ICU), Acute Kidney Injury (KDIGO criteria), Stroke, and All-cause Mortality. Secondary endpoints include the duration of mechanical ventilation and length of ICU/hospital stay. The study aims to provide evidence-based thresholds for intraoperative blood pressure management to improve patient outcomes.
Interventions
None listed
Sponsors
Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of Mechanical Ventilation | Up to 30 days | Time from ICU admission to successful extubation (in hours). |
| Length of Hospital Stay | Up to 30 days | Total duration of hospital stay from surgery to discharge (in days) |
| Length of Intensive Care Unit (ICU) Stay | Up to 30 days | Time from admission to the Intensive Care Unit immediately after surgery until discharge to the ward (in days). |
Countries
Turkey (Türkiye)
Contacts
CONTACTOsman Uzundere, M.D.
Outcome results
None listed