Impact of Intraoperative Hemodynamic Instability on Outcomes in Cardiac Surgery

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorSaglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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).

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

230 Participants
are grouped into 2 trial groups
Group A: Hemodynamic Instability Group
Group B: Hemodynamically Stable Group

Trial outcomes

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.

Time frame
Up to 30 days post-operation

Secondary outcomes

1

Duration of Mechanical Ventilation

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

Time frame
Up to 30 days
2

Length of Hospital Stay

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

Time frame
Up to 30 days
3

Length of Intensive Care Unit (ICU) Stay

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

Time frame
Up to 30 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.