Actively Recruiting

Age: 18Years +
All Genders
ID07324694

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

Led by Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital · Updated on 2026-01-12

230

Participants Needed

1

Research Sites

2 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to evaluate the impact of intraoperative hemodynamic instability during elective cardiac surgery on major postoperative complications in adults. The study focuses on patients undergoing procedures such as coronary artery bypass grafting or valve replacement/repair with cardiopulmonary bypass. Researchers want to understand how periods of low blood pressure or the need for vasopressors during surgery relate to outcomes like delirium, kidney injury, stroke, or death within 30 days after surgery. Patients will be divided into two groups based on their intraoperative blood pressure: those who experience hemodynamic instability, defined as a mean arterial pressure below 65 mmHg for over 5 minutes or requiring medication support, and those who remain stable without significant hypotension or vasopressor use. The study will record detailed intraoperative heart rate, blood pressure, and medication use to categorize these groups. Participants will be closely monitored for up to 30 days after surgery for adverse events including delirium, acute kidney injury, stroke, and mortality. Researchers will also track secondary outcomes such as the length of mechanical ventilation, ICU stay, and total hospital stay. Data collection includes clinical assessments, monitoring of vital signs, and recording medication use. This observational study aims to better define blood pressure management during cardiac surgery to improve patient recovery.

CONDITIONS

Brief Title

Impact of Intraoperative Hemodynamic Instability on Outcomes in Cardiac Surgery

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients aged 18 years or older
  • Scheduled for elective cardiac surgery such as coronary artery bypass grafting, valve replacement, repair, or combined procedures
  • Surgery must be performed with cardiopulmonary bypass
  • Preoperative sinus rhythm (normal heart rhythm)
  • Signed informed consent form
Not Eligible

You will not qualify if you...

  • Emergency or salvage cardiac surgery
  • Off-pump coronary artery bypass grafting
  • Requirement for mechanical circulatory support before surgery (e.g., intra-aortic balloon pump or ECMO)
  • Chronic kidney failure requiring dialysis before surgery
  • Pre-existing cognitive impairment, dementia, or psychiatric disorders that affect cooperation
  • Pregnancy

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Day of surgery

Participants undergo cardiac surgery during which intraoperative hemodynamic data such as blood pressure and medication use are recorded.

1 surgical visit

Post-operative Follow-up

Duration - Up to 30 days post-operation

Participants are monitored for major adverse events including delirium, kidney injury, stroke, and mortality, as well as duration of mechanical ventilation and length of hospital and ICU stay.

Approximately 3 to 5 post-operative visits

Trial Site Locations

Total: 1 location

1

Gazi Yaşargil Training and Research Hospital

Diyarbakır, Diyarbakır, Turkey (Türkiye), 21070

Actively Recruiting

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Research Team

O

Osman Uzundere, M.D.

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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Published Research Related To This Trial

Perioperative blood pressure variability as a risk factor for postoperative delirium in the patients receiving cardiac surgery.

Xiao Shen, Hong Tao, Wenxiu Chen...

https://pubmed.ncbi.nlm.nih.gov/39581994

The haemodynamic instability score: Development and internal validation of a new rating method of intra-operative haemodynamic instability.

Edward Buitenwerf, Mats F Boekel, Marieke I van der Velde...

https://pubmed.ncbi.nlm.nih.gov/30624247