NCT06082401 Evaluating the Addition of Hemodiafiltration to EVLP - Impact on the Regeneration of Marginal Donor Lungs
| NCT ID | NCT06082401 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Medical University of Vienna |
| Condition | Lung Diseases |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2022-09-01 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 30 participants in total. It began in 2022-09-01 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The primary objective of the study is the evaluation of the effect of hemodiafiltration during ex vivo lung perfusion in marginal donor lungs, and its feasibility. The hypothesis of this study is that this therapy could stabilize perfusate electrolyte composition, remove toxins and waste products, normalize pH levels and prevent edema formation, thereby reconditioning marginal donor lungs for transplantation. The proposed pilot study addresses the unmet clinical needs in several aspects: a) for the first time a homeostatic device will be introduced in EVLP to reach stable perfusate composition; b) the proposed modification of the standard EVLP could lead to longer perfusion times, making elective transplantation possible and setting the base for possible ex vivo lung treatments; c) the ultimate effect of the proposed study is to increase organ availability through reconditioning of marginal donor lungs.
Eligibility 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
Contact & Investigator
Alberto Benazzo, MD
PRINCIPAL INVESTIGATOR
Medical University of Vienna
Frequently Asked Questions
Who can join the NCT06082401 clinical trial?
This trial is open to participants of all sexes, studying Lung Diseases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06082401 currently recruiting?
Yes, NCT06082401 is actively recruiting participants. Contact the research team at panja.boehm@meduniwien.ac.at for enrollment information.
Where is the NCT06082401 trial being conducted?
This trial is being conducted at Vienna, Austria.
Who is sponsoring the NCT06082401 clinical trial?
NCT06082401 is sponsored by Medical University of Vienna. The principal investigator is Alberto Benazzo, MD at Medical University of Vienna. The trial plans to enroll 30 participants.