Comparing hemofilters and hemodialyzers during heart surgery in children
Hemofilters vs. Hemodialyzers: Impacts on Cytokine Removal During Cardiopulmonary Bypass in Pediatric Cardiac Surgery
This study is testing whether using hemofilters or hemodialyzers during heart surgery in children helps reduce inflammation and improve recovery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | N/A to 15 Years |
| Sex | All |
| Sponsor | Alnas Hospital Academic / other |
| Locations | 1 site (Shubra El Kheima) |
| Trial ID | NCT06792565 on ClinicalTrials.gov |
What this trial studies
This study compares the effectiveness of hemofilters and hemodialyzers in removing cytokines during cardiopulmonary bypass (CPB) in pediatric patients undergoing elective cardiac surgery. The research focuses on understanding how these two devices impact the systemic inflammatory response that can occur during CPB. By evaluating the safety and efficacy of hemodialyzers, which are more accessible in low-resource settings, the study aims to provide insights that could improve patient outcomes. The trial will involve pediatric patients aged 1 to 15 years who require CPB for more than 60 minutes.
Who should consider this trial
Good fit: Ideal candidates are pediatric patients aged 1 to 15 years undergoing elective cardiothoracic surgery requiring cardiopulmonary bypass.
Not a fit: Patients with signs of sepsis, previous cardiac surgeries, or preoperative renal failure will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the safety and effectiveness of cardiac surgeries in children by optimizing cytokine removal during CPB.
How similar studies have performed: Preliminary data suggests that using hemodialyzers may be safe, but this approach is relatively novel and not extensively tested in this specific context.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Shubra El Kheima
- Alnas Hospital — Shubra El Kheima, Egypt (Recruiting)
Study contacts
- Study coordinator: Ahmed M. Abd ElAzim, EBCP
- Email: ahmedazemo89@gmail.com
- Phone: +201004096405
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.