Evaluating the Addition of Hemodiafiltration to Ex-vivo Lung Perfusion - Impact on the Regeneration of Marginal Donor Lungs: a Prospective Randomized Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- suitability for transplantation of the lungs after 6 hours of EVLP with HDF
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
suitability for transplantation of the lungs after 6 hours of EVLP with HDF
时间窗: 6 hours
PGD grade 3 at 72 hours after transplantation
时间窗: 72 hours
for all transplanted organs
次要结局
- survival(months)
- length of ICU stay(up to 100 days)
- length of hospital stay(up to 200 days)
- Length of mechanical ventilation(up to 100 days)
- lung function parameters (MEF50)(24 months)
研究者
Alberto Benazzo
Principal Investigator
Medical University of Vienna