Compare the Impact of Hemofilters and Hemodialyzers on Cytokine Removal During Cardiopulmonary Bypass in Pediatric Cardiac Surgery

Effects of Blood Filters on Inflammation in Children's Heart Surgery

Recruiting
15 years or below
All
Phase N/A
40 participants needed
1 Location

Study Overview

Cardiopulmonary bypass (CPB) allowed the correction of several congenital heart diseases such as intracardiac malformations, but it is well known that this is not a harmless procedure because it can lead to a systemic inflammatory response syndrome (SIRS), with activation of complement, cytokines, coagulation, and fibrinolysis pathways.

Due to economic causes, hemofilters became less available in low-resource countries, which forced perfusionists to use hemodialyzers instead during CPB. Preliminary data showed the potential safety of using hemodialyzers instead of hemofilters in Zero-balanced ultrafiltration.

The Objectives of the study This study aims to compare impact of hemofilters and hemodialyzers on cytokine removal during cardiopulmonary bypass in pediatric cardiac surgery.

Eligibility Criteria

You may be eligible for this study if you meet the following criteria:

  • Conditions: Cardio-pulmonary Bypass, Cytokine
  • Age: 15 years or below
  • Gender: All

Inclusion Criteria:

  1. Pediatric patients who are undergoing elective cardiothoracic surgery which cardiopulmonary bypass will be conducted.
  2. Age of patients from 1 year to 15 years.
  3. CPB duration more than 60 minutes.

Exclusion Criteria:

  1. Pediatric patients with known signs of sepsis.
  2. Pediatric patients having had previous cardiothoracic surgery.
  3. Preoperative renal failure.
  4. Preoperative cardiogenic shock requiring the use of inotropes.
  5. Preoperative lactate concentration > 2 mmol/L.

Updated on 23 Jan 2025. Study ID: NCT06792565

This study investigates the effects of using hemofilters and hemodialyzers on cytokine removal during cardiopulmonary bypass in children undergoing heart surgery. Cardiopulmonary bypass is a procedure that helps correct heart problems, but it can cause a reaction in the body called systemic inflammatory response syndrome (SIRS). This reaction involves various body systems, including the immune system and blood clotting processes.

In this study, children will undergo heart surgery using either a hemofilter or a hemodialyzer during the bypass procedure. Hemofilters and hemodialyzers are devices used to filter the blood, but they work differently. This research aims to find out which device is more effective at removing cytokines, which are proteins that can cause inflammation, from the blood.

  • Who can participate: Children aged 1 to 15 years who are having planned heart surgery with cardiopulmonary bypass lasting more than 60 minutes can join. They should not have signs of sepsis, previous heart surgery, kidney failure, or certain pre-surgery conditions.
  • Study details: Participants will have heart surgery with the use of either a hemofilter or a hemodialyzer during the procedure. These devices help to filter the blood and manage inflammation during the surgery.

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