Impact of Intraoperative Hemodynamic Instability on Outcomes in Cardiac Surgery

NCT07324694 | Recruiting

• 1 other identifier: GYTRH-KVC-IOHI-01
• Study Type: observational
• Target: 230
• Locations: 1 country
• Sites: 1

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.

Conditions

Intraoperative Hemodynamic Instability; Cardiac Surgery; Postoperative Complication; Acute Kidney Injury; Postoperative Delirium (POD)

Keywords

Intraoperative Hypotension; Cardiopulmonary Bypass; Mean Arterial Pressure; Cohort Study

Outcome Measures

Primary Outcomes (1)

• Incidence of Composite Adverse Events

  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.

  Up to 30 days post-operation

Secondary Outcomes (3)

• Duration of Mechanical Ventilation

  Up to 30 days

• Length of Hospital Stay

  Up to 30 days

• Length of Intensive Care Unit (ICU) Stay

  Up to 30 days

Study Arms (2)

Hemodynamic Instability Group

Patients who exhibit intraoperative hemodynamic instability, defined as Mean Arterial Pressure (MAP) \< 65 mmHg for \>5 minutes continuously, or requiring vasopressor/inotropic support to maintain MAP.

Hemodynamically Stable Group

Patients who maintain intraoperative hemodynamic stability without significant hypotension episodes (MAP \> 65 mmHg) or vasopressor requirement beyond baseline anesthesia induction.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients undergoing elective cardiac surgery with cardiopulmonary bypass at a tertiary care university hospital.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital: lead

Study Sites (1)

Gazi Yaşargil Training and Research Hospital

Diyarbakır, Diyarbakır, 21070, Turkey (Türkiye)

RECRUITING

Related Publications (3)

• 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 RESULT

• 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 RESULT

• 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 RESULT

MeSH Terms

Conditions

Postoperative Complications; Acute Kidney Injury; Emergence Delirium

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Osman Uzundere, M.D.

CONTACT

+905330206362; osmanuzundere@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 23, 2025
• First Posted: January 7, 2026
• Study Start: April 26, 2025
• Primary Completion: January 20, 2026
• Study Completion: February 5, 2026
• Last Updated: January 12, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)