Evaluating hemodiafiltration for improving marginal donor lungs during ex vivo lung perfusion

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.