Can a method called goal-directed perfusion help reduce damage to blood cells and swelling during heart surgery using a cardiopulmonary bypass machine? Comparison with the conventional method

Not Applicable

• Conditions: Cardiac surgery patients who require cardiopulmonary bypass procedure; Surgery

• Registration Number: ISRCTN17452821
• Lead Sponsor: Gadjah Mada University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-04-04
• Last Update Posted: 9 October 2023
• Study Completion: 2023-10-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. Cardiac surgery patients that require CPB procedures
2. New York Heart Association (NYHA) < 3
3. Body weight 40 - 100 kg

Exclusion Criteria

Patients under extra corporeal circulation before surgery: IABP, hemodialysis, RRT, intraventricular assisted device

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 1. Hemolysis markers<br> 1.1. Plasma free hemoglobin is measured with colorimetric hemoglobin assay, at baseline, 60, 90, and 120 min during CPB<br> 1.2. Haptoglobin is measured with ELISA method, at baseline, 60, 90, and 120 min during CPB<br> 2. Inflammatory markers<br> 2.1. Interleukin – 6 is measured with ELISA method, at baseline, 60, 90, and 120 min during CPB<br> 2.2. TNF-a is measured with ELISA method, at baseline, 60, 90, and 120 min during CPB<br>

Secondary Outcome Measures

Name	Time	Method
<br> 1. Complete blood count, peripheral blood morphology, blood glucose, electrolytes, urea and creatinine, lactate, arterial blood glass are measured in accordance with lab protocols, at baseline, 60, 90, and 120 min during CPB<br> 2. Duration of postoperative ventilator use, ICU length of stay are measured as hours and days, respectively<br>