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

Alnas Hospital

Status: Completed

Conditions: Cytokine; Cardio-pulmonary Bypass

Treatments: Device: hemofilter; Device: hemodializer

Study type: Interventional

Funder types: Other

Identifiers

NCT06792565

RHDIRB-NA-240823-01UC-NPO-N032

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: Under 15 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

hemodialyzers

Experimental group

Description:

20 patients

Treatment:

Device: hemodializer

hemofilters

Active Comparator group

Description:

20 patients

Treatment:

Device: hemofilter