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

The comparison between goal-directed perfusion vs conventional method in cardiopulmonary pulmonary bypass: effects on hemolysis and inflammation

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN17452821

Enrollment

Registered

2023-04-04

Start date

2023-07-01

Completion date

Unknown

Last updated

2023-10-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac surgery patients who require cardiopulmonary bypass procedure Surgery

Interventions

The study will use a double-blind randomized clinical trial design to investigate the effects of goal-directed perfusion using the heart-lung machine on hemolysis and inflammation in adult patients un

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

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

Measure

Time frame

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

—

Secondary

Measure	Time frame
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 2. Duration of postoperative ventilator use, ICU length of stay are measured as hours and days, respectively	—

Countries

Indonesia

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026