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

NCT ID: NCT06792565

Last Updated: 2025-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-22

Study Completion Date

2025-10-01

Brief Summary

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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.

Detailed Description

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Conditions

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Cardio-pulmonary Bypass Cytokine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

compare impact of hemofilters and hemodialyzers on cytokine removal during cardiopulmonary bypass in pediatric cardiac surgery.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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hemodialyzers

20 patients

Group Type EXPERIMENTAL

hemodializer

Intervention Type DEVICE

Fresenius Helixone FX5 (61346 Bad Homburg, Germany)

hemofilters

20 patients

Group Type ACTIVE_COMPARATOR

hemofilter

Intervention Type DEVICE

Medica (741036 Medolla, Italy)

Interventions

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hemodializer

Fresenius Helixone FX5 (61346 Bad Homburg, Germany)

Intervention Type DEVICE

hemofilter

Medica (741036 Medolla, Italy)

Intervention Type DEVICE

Eligibility Criteria

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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.
Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alnas Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Amal F Rizk, MD

Role: STUDY_DIRECTOR

Alnas Hospital

Locations

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Alnas Hospital

Shubrā al Khaymah, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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

Identifier Type: -

Identifier Source: org_study_id