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

NCT06082401 | Recruiting DMC

• 1 other identifier: FILONEX
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Diseases

Outcome Measures

Primary Outcomes (2)

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

  6 hours

• PGD grade 3 at 72 hours after transplantation

  for all transplanted organs

  72 hours

Secondary Outcomes (5)

• survival

  months

• Length of mechanical ventilation

  up to 100 days

• length of ICU stay

  up to 100 days

• length of hospital stay

  up to 200 days

• lung function parameters (MEF50)

  24 months

Study Arms (2)

Treatment Group

EXPERIMENTAL

EVLP + HDF

Device: hemodiafiltration (HDF); Device: Ex vivo lung perfusion (EVLP)

Control Group

ACTIVE COMPARATOR

EVLP

Device: Ex vivo lung perfusion (EVLP)

Interventions

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.

Also known as: device: multiFiltrate Ci-Ca(R) (by Fresenius)

Treatment Group

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.

Also known as: device: XPS (TM) (by XVIVO)

Control Group; Treatment Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• For donor organs:
• Bilateral consolidations in donor lungs
• Lungs from donors with chest trauma
• Lungs from drowned donors
• For patients receiving lung transplantation:
• Patients on the intensive care unit (ICU) prior to transplantation, with mechanical ventilation and/or extracorporeal membrane oxygenation (ECMO) support
• Re-transplantations

Sponsors & Collaborators

• Medical University of Vienna: lead
• XVIVO Perfusion: collaborator

Study Sites (1)

Medical University of Vienna

Vienna, 1090, Austria

RECRUITING

MeSH Terms

Conditions

Lung Diseases

Interventions

Hemodiafiltration

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Renal Dialysis; Renal Replacement Therapy; Therapeutics; Sorption Detoxification; Hemofiltration; Extracorporeal Circulation; Surgical Procedures, Operative

Study Officials

• Alberto Benazzo, MD

  Medical University of Vienna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Panja M Boehm, MD

CONTACT

004314040056440; panja.boehm@meduniwien.ac.at

Alberto Benazzo, MD

CONTACT

004314040056440; alberto.benazzo@meduniwien.ac.at

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 4, 2023
• First Posted: October 13, 2023
• Study Start: September 1, 2022
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: May 14, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)