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

NCT06792565 | Completed

• 1 other identifier: RHDIRB-NA-240823-01UC-NPO-N032
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• IL6 level as a proinflammatory cytokine

  preoperatively after induction of anesthesia (T1), after removal of aorta cross clamp and before starting zero-balanced ultrafiltration (T2) and after coming off CPB (T3).

Secondary Outcomes (1)

• Other proinflammatory cytokine

  preoperatively after induction of anesthesia (T1), after removal of aorta cross clamp and before starting zero-balanced ultrafiltration (T2) and after coming off CPB (T3).

Study Arms (2)

hemodialyzers

EXPERIMENTAL

20 patients

Device: hemodializer

hemofilters

ACTIVE COMPARATOR

20 patients

Device: hemofilter

Interventions

hemodializer DEVICE

Fresenius Helixone FX5 (61346 Bad Homburg, Germany)

hemodialyzers

hemofilter DEVICE

Medica (741036 Medolla, Italy)

hemofilters

Eligibility Criteria

• Age: Up to 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Alnas Hospital: lead

Study Sites (1)

Alnas Hospital

Shubrā al Khaymah, Egypt

Location

Study Officials

• Amal F Rizk, MD

  Alnas Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: compare impact of hemofilters and hemodialyzers on cytokine removal during cardiopulmonary bypass in pediatric cardiac surgery.

Study Record Dates

• First Submitted: January 20, 2025
• First Posted: January 24, 2025
• Study Start: March 22, 2024
• Primary Completion: June 1, 2025
• Study Completion: October 1, 2025
• Last Updated: December 16, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE

Locations

EG (1)