Evaluating hemodiafiltration for improving marginal donor lungs during ex vivo lung perfusion
Evaluating the Addition of Hemodiafiltration to Ex-vivo Lung Perfusion - Impact on the Regeneration of Marginal Donor Lungs: a Prospective Randomized Pilot Study
This study is testing if a new method called hemodiafiltration can help improve the condition of certain donor lungs during a special treatment process to make them better for transplantation.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Sex | All |
| Sponsor | Medical University of Vienna Academic / other |
| Locations | 1 site (Vienna) |
| Trial ID | NCT06082401 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the impact of hemodiafiltration (HDF) on the regeneration of marginal donor lungs during ex vivo lung perfusion (EVLP). The researchers hypothesize that HDF can stabilize the electrolyte composition of the perfusate, remove toxins, normalize pH levels, and prevent edema formation, thereby enhancing the viability of marginal donor lungs for transplantation. This pilot study introduces a homeostatic device to EVLP, potentially allowing for longer perfusion times and increasing organ availability. The study focuses on marginal donor lungs that meet specific criteria, including age and health status.
Who should consider this trial
Good fit: Ideal candidates for this study are marginal donor lungs from individuals aged 55 and older with specific health criteria.
Not a fit: Patients with bilateral consolidations in donor lungs or those requiring re-transplantation may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly increase the availability of viable lungs for transplantation, improving outcomes for patients with severe lung diseases.
How similar studies have performed: While this approach is novel, similar studies have shown promise in improving organ viability through advanced perfusion techniques.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Marginal donor lungs according to the ISHLT criteria (18) * PaO2/FiO2 ratio \< 400 (with FiO2=1.0 and PEEP=5-8cmH2O) * Donor age ≥ 55 years * Smoking history ≥ 20 pack-years * Infiltrates in chest radiograph * Significant secretions in bronchoscopy * Organisms on sputum gram stain * Donor age \> 18 years Exclusion Criteria: For donor organs: * Bilateral consolidations in donor lungs * Lungs from donors with chest trauma * Lungs from drowned donors For patients receiving lung transplantation: * Inclusions in other interventional studies * Patients on the intensive care unit (ICU) prior to transplantation, with mechanical ventilation and/or extracorporeal membrane oxygenation (ECMO) support * Re-transplantations
Where this trial is running
Vienna
- Medical University of Vienna — Vienna, Austria (Recruiting)
Study contacts
- Principal investigator: Alberto Benazzo, MD — Medical University of Vienna
- Study coordinator: Panja M Boehm, MD
- Email: panja.boehm@meduniwien.ac.at
- Phone: 004314040056440
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.