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NCT Number: NCT07324694

Impact of Intraoperative Hemodynamic Instability on Outcomes in Cardiac Surgery

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.

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Key information

Conditions

Cardiac Surgery Acute Kidney Injury Confusion Delirium Emergence Delirium Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Intraoperative Hemodynamic Instability Kidney Diseases Male Urogenital Diseases Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complication Postoperative Complications Postoperative Delirium (POD) Renal Insufficiency Signs and Symptoms Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Gazi Yaşargil Training and Research Hospital

Diyarbakır, 21070, Turkey (Türkiye)

Location status: Recruiting

Location contact

Osman Uzundere, M.D.

CONTACT

[email protected]

+905330206362

About this study

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:

  • Hemodynamic Instability Group: Patients experiencing MAP < 65 mmHg for more than 5 minutes continuously or requiring significant vasopressor/inotropic support to maintain target pressure.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Incidence of Composite Adverse Events

    Time frame: 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 outcomes

  1. Duration of Mechanical Ventilation

    Time frame: Up to 30 days

    Time from ICU admission to successful extubation (in hours).

  2. Length of Hospital Stay

    Time frame: Up to 30 days

    Total duration of hospital stay from surgery to discharge (in days)

  3. Length of Intensive Care Unit (ICU) Stay

    Time frame: Up to 30 days

    Time from admission to the Intensive Care Unit immediately after surgery until discharge to the ward (in days).

Study contacts

Contact information is provided by the study sponsor or research team.

Osman Uzundere, M.D.

CONTACT

[email protected]

+905330206362

Sponsors and collaborators

Lead sponsor

Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

Other

Registry information

Official study title

Impact of Intraoperative Hemodynamic Instability on Postoperative Major Adverse Events in Cardiac Surgery Patients: A Prospective Cohort Study

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 7, 2026
Registry last updated
Jan 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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