A Prospective Feasibility Trail to Compare the Efficacy of Intermittent Surface Oxygenation With Continuous Surface Oxygenation During Hypothermic Machine Perfusion of Kidneys Donated After Circulatory Death
Trial Snapshot
- Phase
- Phase 3
- Status
- Recruiting
- Sponsor
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Functional delayed graft function
Study Overview
Brief Summary
The aim of the study is to evaluate the feasibility of this bubble and surface oxygenation and to determine the optimal timing of surface oxygenation (continuous versus intermittent) as alternative for membrane-oxygenated kidneys, originating from DCD donors, during HMP on early graft function in clinical practice.
Detailed Description
Kidneys originating from deceased donors after circulatory death (DCD), category 3 and 5 (controlled) will be preserved from procurement until transplantation on hypothermic machine perfusion conditions and prospectively randomized into 2 study groups: 1) intermittent surface oxygenation during HMP (surface oxygenation interrupted during organ transport (2-4h)(I-HMPO2 group), and 2) continuous surface oxygenation during HMP (surface oxygenation during the whole machine preservation period included organ transport)(C-HMPO2 group).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Listed for a renal transplantation due to end stage renal disease
- •Willingness to comply with the protocol procedures for the duration of the study included scheduled follow-up visits and examinations.
Exclusion Criteria
- •Multi-organ recipients
- •Dual kidney transplantation
Arms & Interventions
C-HMPO2
continuous surface oxygenation during HMP (surface oxygenation during the whole machine preservation period included organ transport)
Intervention: Oxygen (Drug)
I-HMPO2
intermittent surface oxygenation during hypothermic machine perfusion (surface oxygenation interrupted during organ transport)
Intervention: Oxygen (Drug)
Outcomes
Primary Outcomes
Functional delayed graft function
Time Frame: first 7 days after transplantation
defined as the absence of a decrease in the serum creatinine level of at least 10% per day for at least 3 consecutive days in the first 7 days after transplantation (not including patients in whom acute rejection of calcineurin inhibitor toxicity is proven on biopsy)
Secondary Outcomes
- Delayed graft function(first 7 days after transplantation)
- Serum creatinine reduction ratio(Day 1-2 after transplantation)
- Patient survival (censored and uncensored for death)(From 1-365 days after transplantation)
- Glomerular filtration rate at 1 year after transplantation(At 1 year after transplantation (window 30 days))
- Primary non-function(Until 3 months after transplantation)
- Metabolic analysis on preservation fluid(Baseline and pre-surgery)
- Need for dialysis after transplantation(0-30 days after transplantation)
- Biopsy-proven acute rejection(Until 1 year after transplantation with window of 10 days)
- Metabolic analysis on kidney preservation tissue(Baseline and pre-surgery)
- Graft survival(From 1-365 days after transplantation)
- Estimated glomerular filtration rate(At 3, 6, and 12 months after transplantation with window of 10 days)