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CompletedNCT06792565Updated Dec 16, 2025

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

An interventional study of hemodializer and hemofilter in Cardio-pulmonary Bypass and Cytokine, sponsored by Alnas Hospital. Completed at 1 site in Egypt. Open to participants aged Up to 15 Years. Per ClinicalTrials.gov, last updated 2025-12-16.

Sponsored by Alnas Hospital · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 9 months after the study started (first participant enrolled Mar 2024, registered Jan 2025).
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
Up to 15 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Cardio-pulmonary Bypass
  • Cytokine
03

In context

Lead sponsor

Alnas Hospital is the lead sponsor of 2 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 15 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (actual)

Study arms

  • Experimental
    hemodialyzers

    20 patients

    Device: hemodializer

  • Active comparator
    hemofilters

    20 patients

    Device: hemofilter

Interventions

  • Devicehemodializer

    Fresenius Helixone FX5 (61346 Bad Homburg, Germany)

  • Devicehemofilter

    Medica (741036 Medolla, Italy)

06

What researchers measure

Primary outcomes

  1. IL6 level as a proinflammatory cytokine

    Time frame: 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

    IL1β, Lactate level

    Time frame: 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).

07

Study locations

1 site
  • Alnas Hospital
    Shubrā al Khaymah, Egypt
08

References and documents

Publications

  • Abdelazim AM, Alaaeldin B, Amer AM, Rizk A, Mahmoud D, Elsobky Y, Tawfik H, Fadaly AS, Elshazly M. Hemofilters versus hemodialyzers: impacts on cytokine removal during cardiopulmonary bypass in pediatric cardiac surgery: a randomized controlled trial. J Cardiothorac Surg. 2026 Apr 13;21(1):199. doi: 10.1186/s13019-026-04058-0. PubMed 41975514 ↗

Individual participant data

Plan to share: Yes

Supporting information: Study protocol, Sap, Icf, Analytic code

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 16, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06792565
Lead sponsor
Alnas Hospital
Responsible party
Sponsor
First posted
Jan 24, 2025
Start date
Mar 22, 2024
Primary completion
Jun 1, 2025
Completion
Oct 1, 2025
Last update
Dec 16, 2025

Study contacts

Amal F Rizk, MD
study director · Alnas Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.

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