Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| hemodialyzers | Experimental | 20 patients |
|
| hemofilters | Active Comparator | 20 patients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| hemodializer | Device | Fresenius Helixone FX5 (61346 Bad Homburg, Germany) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Other proinflammatory cytokine | IL1β, Lactate level | 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). |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Amal F Rizk, MD | Alnas Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alnas Hospital | Shubrā al Khaymah | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41975514 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
compare impact of hemofilters and hemodialyzers on cytokine removal during cardiopulmonary bypass in pediatric cardiac surgery.
Not provided
Not provided
Not provided
Not provided
| hemofilter |
| Device |
Medica (741036 Medolla, Italy) |
|