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NCT Number: NCT06082401

Evaluating the Addition of Hemodiafiltration to EVLP - Impact on the Regeneration of Marginal Donor Lungs

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.

Recruiting

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

hemodiafiltration (HDF)

Device

Hemodiafiltration (HDF) is a variation of conventional HD. By the addition of a substitution solution, convection forces are significantly increased. This substitution solution is added to the blood and is completely removed again in the dialyzer. This increases the negative pressure on the dialysate side and the removal of toxins through convection. The substitution solution can be added in a pre-dilution (before the dialyzer) or post-dilution (after the dialyzer) manner. Pre-dilution is associated with longer run times, less filter clotting, but is also less effective in removing toxins. Post-dilution offers a better toxin clearance capacity, but is associated with an increased risk of filter clotting. Several studies have shown that HDF provides higher clearance rates for both small and middle molecule solutes. Moreover, effective cytokine removal has been shown in HDF both in acute and chronic renal disease patients.

Other names: device: multiFiltrate Ci-Ca(R) (by Fresenius)

Ex Vivo Lung Perfusion (EVLP)

Device

Lung transplantation has become a standard treatment for patients suffering from end-stage lung diseases. One of the major obstacles in the modern transplant era is the fact that the need for organs by far exceeds availability. This leads to growing waiting lists with mortality rates ranging between 10-30%. On the other hand, up to 80% of offered lungs from brain dead donors are rejected because they do not meet predefined donor selection criteria.

Recently, ex vivo lung perfusion (EVLP) has become available as a tool to expand the donor pool. Based on experimental work by Stig Steen, the Toronto lung transplant group developed an EVLP system with the purpose to evaluate lungs with uncertain quality. Consequently, Aigner et al. have expanded the indications for EVLP by showing that primarily unacceptable donor lungs can be reconditioned and then become suitable for transplantation. This concept of organ repair by EVLP has recently been highlighted by a number of publications.

Other names: device: XPS (TM) (by XVIVO)

Primary outcomes

  1. suitability for transplantation of the lungs after 6 hours of EVLP with HDF

    Time frame: 6 hours

  2. PGD grade 3 at 72 hours after transplantation

    Time frame: 72 hours

    for all transplanted organs

Secondary outcomes

  1. survival

    Time frame: months

    survival assessed at 12 and 24 months

  2. Length of mechanical ventilation

    Time frame: up to 100 days

  3. length of ICU stay

    Time frame: up to 100 days

  4. length of hospital stay

    Time frame: up to 200 days

  5. lung function parameters (MEF50)

    Time frame: 24 months

    1, 3, 6, 12 and 24 months after transplantation

Study contacts

Contact information is provided by the study sponsor or research team.

Alberto Benazzo, MD

CONTACT

[email protected]

004314040056440

Panja M Boehm, MD

CONTACT

[email protected]

004314040056440

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Collaborators

  • XVIVO Perfusion

Registry information

Official study title

Evaluating the Addition of Hemodiafiltration to Ex-vivo Lung Perfusion - Impact on the Regeneration of Marginal Donor Lungs: a Prospective Randomized Pilot Study

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Oct 13, 2023
Registry last updated
May 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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