Impact of Intraoperative Hemodynamic Instability on Outcomes in Cardiac Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Cardiac Surgery, Intraoperative Hemodynamic Instability, Postoperative Complication, Acute Kidney Injury. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Turkey (Türkiye)
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Impact of Intraoperative Hemodynamic Instability on Postoperative Major Adverse Events in Cardiac Surgery Patients: A Prospective Cohort Study
Overview
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.
Primary outcome measures
- Incidence of Composite Adverse Events [Time frame: Up to 30 days post-operation]
Secondary outcome measures (3)
- Duration of Mechanical Ventilation [Time frame: Up to 30 days]
- Length of Hospital Stay [Time frame: Up to 30 days]
- Length of Intensive Care Unit (ICU) Stay [Time frame: Up to 30 days]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Turkey (Türkiye) · 1 center
- Gazi Yaşargil Training and Research Hospital — Diyarbakır
Publications
- Shen X, Tao H, Chen W, Sun J, Jin R, Zhang W, Hong L, Zhang C. Perioperative blood pressure variability as a risk factor for postoperative delirium in the patients receiving cardiac surgery. BMC Anesthesiol. 2024 Nov 25;24(1):424. doi: 10.1186/s12871-024-02817-x. PMID 39581994
- D'Amico F, Fominskiy EV, Turi S, Pruna A, Fresilli S, Triulzi M, Zangrillo A, Landoni G. Intraoperative hypotension and postoperative outcomes: a meta-analysis of randomised trials. Br J Anaesth. 2023 Nov;131(5):823-831. doi: 10.1016/j.bja.2023.08.026. Epub 2023 Sep 20. PMID 37739903
- Buitenwerf E, Boekel MF, van der Velde MI, Voogd MF, Kerstens MN, Wietasch GJKG, Scheeren TWL. The haemodynamic instability score: Development and internal validation of a new rating method of intra-operative haemodynamic instability. Eur J Anaesthesiol. 2019 Apr;36(4):290-296. doi: 10.1097/EJA.0000000000000941. PMID 30624247
Identifiers
NCT: NCT07324694 · GYTRH-KVC-IOHI-01