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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is studying blood pressure instability during cardiac surgery and whether it leads to complications like kidney injury or delirium afterward — is my planned surgery the type that would be included in this study, and could my doctor explain how closely my own risk for these complications would be monitored?
2Since this is listed as a phase 'NA' observational-style study measuring how often serious complications happen together, does participating mean I'd receive any different treatment, or would the research team mainly be collecting data about what happens to me during and after surgery?
3The trial tracks postoperative delirium as one of the outcomes — how common is that after the kind of cardiac surgery I'm facing, and is there anything my care team already does to reduce that risk regardless of whether I'm in this study?
4Acute kidney injury is one of the complications this trial is watching for — given my current kidney function, should that be a concern for me personally, and would being in this study change how aggressively my team would respond if early signs appeared?
5Before I consider joining this study, could my doctor walk me through whether standard post-surgery monitoring at this hospital would already catch the same complications this trial is tracking, or whether enrolling would give me any additional oversight or follow-up care?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of Composite Adverse Events
Timeframe: Up to 30 days post-operation
Trial details
NCT IDNCT07324694
SponsorSaglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital