NCT06792565

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

Hemofilters vs. Hemodialyzers: Impacts on Cytokine Removal During Cardiopulmonary Bypass in Pediatric Cardiac Surgery

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Alnas Hospital · Academic / Other
• Sex: All
• Age: 15 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Cardio-pulmonary Bypass
• Cytokine

Interventions

Type	Name	Description
DEVICE	hemodializer	Fresenius Helixone FX5 (61346 Bad Homburg, Germany)
DEVICE	hemofilter	Medica (741036 Medolla, Italy)

Timeline

• Start date: 2024-03-22
• Primary completion: 2025-06-01
• Completion: 2025-10-01
• First posted: 2025-01-24
• Last updated: 2025-12-16

Locations

1 site across 1 country: Egypt