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Completed

NCT Number: NCT06792565

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

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.

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Key information

Conditions

Cardio-pulmonary Bypass Cytokine

Age range

Up to 15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alnas Hospital

Shubrā al Khaymah, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

hemodializer

Device

Fresenius Helixone FX5 (61346 Bad Homburg, Germany)

hemofilter

Device

Medica (741036 Medolla, Italy)

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

    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).

    IL1β, Lactate level

Sponsors and collaborators

Lead sponsor

Alnas Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 24, 2025
Registry last updated
Dec 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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