Comparing oxygen delivery methods for preserving kidneys from deceased donors
A Prospective Feasibility Trail to Compare the Efficacy of Intermittent Surface Oxygenation With Continuous Surface Oxygenation During Hypothermic Machine Perfusion of Kidneys Donated After Circulatory Death
This study tests two ways of delivering oxygen to preserve kidneys from deceased donors to see which method helps them work better after transplantation.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Cliniques universitaires Saint-Luc- Université Catholique de Louvain Academic / other |
| Locations | 1 site (Brussels, Woluwé-Saint-Lambert) |
| Trial ID | NCT05430620 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of two different methods of oxygen delivery during the preservation of kidneys from deceased donors after circulatory death. It involves a randomized approach where kidneys are preserved using hypothermic machine perfusion and assigned to either intermittent or continuous surface oxygenation. The goal is to determine which method leads to better early graft function after transplantation. The study focuses on kidneys at risk for delayed graft function and ischemia-reperfusion injury.
Who should consider this trial
Good fit: Ideal candidates are individuals listed for renal transplantation due to end-stage renal disease.
Not a fit: Patients receiving multi-organ transplants or dual kidney transplants may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve kidney preservation techniques, leading to better transplant outcomes for patients.
How similar studies have performed: Other studies have explored oxygenation methods in kidney preservation, but this specific approach is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Listed for a renal transplantation due to end stage renal disease * Willingness to comply with the protocol procedures for the duration of the study included scheduled follow-up visits and examinations. Exclusion Criteria: * Multi-organ recipients * Dual kidney transplantation
Where this trial is running
Brussels, Woluwé-Saint-Lambert
- Cliniques Universitaires Saint-Luc — Brussels, Woluwé-Saint-Lambert, Belgium (Recruiting)
Study contacts
- Principal investigator: Tom Darius, MD, PhD — Cliniques universitaires Saint-Luc- Université Catholique de Louvain
- Study coordinator: Tom Darius, Phd
- Email: tom.darius@saintluc.uclouvain.be
- Phone: 003227642218
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.