Cardio-pulmonary BypassNCT06792565
Compare the Impact of Hemofilters and Hemodialyzers on Cytokine Removal During Cardiopulmonary Bypass in Pediatric Cardiac Surgery
A study testing hemodializer and hemofilter in people with Cardio-pulmonary Bypass and Cytokine, run by Alnas Hospital at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages Up to 15 years
- Conditions the study is for
- Cardio-pulmonary Bypass, Cytokine
- What is being tested?
- hemodializer and hemofilter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 22 Mar 2024to 1 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Hemofilters vs. Hemodialyzers: Impacts 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.
- Conditions
- Cardio-pulmonary Bypass, Cytokine
- Being tested
- hemodializer, hemofilter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hemodializerDevice
Fresenius Helixone FX5 (61346 Bad Homburg, Germany)
hemofilterDevice
Medica (741036 Medolla, Italy)
| Study group | Role | What they receive |
|---|---|---|
| hemodialyzers | Experimental | 20 patients Receives: Device: hemodializer |
| hemofilters | Active comparator | 20 patients Receives: Device: hemofilter |
What is being measured
The primary outcome is the main question the study is designed to answer.
IL6 level as a proinflammatory cytokine
Measured: 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
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2025
- Study start22 Mar 2024
- Primary completion1 Jun 2025
- Study completion1 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardio-pulmonary BypassStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- compare impact of hemofilters and hemodialyzers on cytokine removal during cardiopulmonary bypass in pediatric cardiac surgery.
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alnas Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amal F Rizk, MD, Study director, Alnas Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06792565
- Sponsor's protocol ID
- RHDIRB-NA-240823-01UC-NPO-N032
- Status last verified
- Dec 2025
- First submitted
- 20 Jan 2025
- Last updated
- 16 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
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
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemofilters vs. Hemodialyzers: Impacts on Cytokine Removal During Cardiopulmonary Bypass in Pediatric Cardiac Surgery
- ClinicalTrials.gov ID
- NCT06792565
- Acronym / sponsor ID
- RHDIRB-NA-240823-01UC-NPO-N032
- Conditions
- Cardio-pulmonary Bypass, Cytokine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Alnas HospitalUniversity, hospital or other
- Study start
- 22 Mar 2024 (actual)
- Primary completion
- 1 Jun 2025 (actual)
- Study completion
- 1 Oct 2025 (actual)
- First posted
- 24 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- compare impact of hemofilters and hemodialyzers on cytokine removal during cardiopulmonary bypass in pediatric cardiac surgery.
| Arm | Type | Receives |
|---|---|---|
| hemodialyzers | Experimental | Device: hemodializer20 patients |
| hemofilters | Active comparator | Device: hemofilter20 patients |
Who may qualify
- Ages
- Up to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hemodializerFresenius Helixone FX5 (61346 Bad Homburg, Germany) | Device | hemodialyzers |
| hemofilterMedica (741036 Medolla, Italy) | Device | hemofilters |
Primary outcome
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).
1 secondary outcome
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2025.
- Derived from this study: PubMed 41975514Abdelazim 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amal F Rizk, MD study director
Alnas Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing hemodializer and hemofilter in people with Cardio-pulmonary Bypass and Cytokine, run by Alnas Hospital at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06792565, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2025.