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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Austria
Medical University of Vienna
RECRUITING
Vienna
Contact Information
Primary
Panja M Boehm, MD
panja.boehm@meduniwien.ac.at
004314040056440
Backup
Alberto Benazzo, MD
alberto.benazzo@meduniwien.ac.at
004314040056440
Time Frame
Start Date: 2022-09-01
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 30
Treatments
Experimental: Treatment Group
EVLP + HDF
Active_comparator: Control Group
EVLP
Related Therapeutic Areas
Sponsors
Leads: Medical University of Vienna
Collaborators: XVIVO Perfusion

This content was sourced from clinicaltrials.gov