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

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

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.

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