A Phase 3 interventional study of Oxygen in Delayed Graft Function, Kidney Transplant; Complications and Ischemia Reperfusion Injury, sponsored by Cliniques universitaires Saint-Luc- Université Catholique de Louvain. Recruiting at 1 site in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-05-23.
Sponsored by Cliniques universitaires Saint-Luc- Université Catholique de Louvain · Phase 3, Interventional, and Treatment
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.
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).
83 studies on the registry are indexed under Delayed Graft Function; 15 are open to participants now.
This study's planned enrollment of 60 is below the median of 90 across 62 interventional studies indexed under Delayed Graft Function.
Browse Delayed Graft Function studies →Cliniques universitaires Saint-Luc- Université Catholique de Louvain is the lead sponsor of 350 studies on the registry; 64 are open to participants now.
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Exclusion Criteria:
intermittent surface oxygenation during hypothermic machine perfusion (surface oxygenation interrupted during organ transport)
Drug: Oxygen
continuous surface oxygenation during HMP (surface oxygenation during the whole machine preservation period included organ transport)
Drug: Oxygen
Active oxygenation during hypothermic machine perfusion by bubble and surface oxygenation. Intermittent surface oxygenation is compared with continuous surface oxygenation during hypothermic machine perfusion
Also known as: feasibility of bubble and surface oxygenation applied to the LifePort Kidney Transporter (Organ Recovery Systems, Diegem, Belgium)
Functional delayed graft function
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)
Time frame: first 7 days after transplantation
Need for dialysis after transplantation
Number of dialysis sessions after transplantation
Time frame: 0-30 days after transplantation
Delayed graft function
defined as the need for dialysis in the first 7 days after transplantation and preceding the return of kidney function
Time frame: first 7 days after transplantation
Serum creatinine reduction ratio
alternative definition of DGF= CRR2 \< or = 30%
Time frame: Day 1-2 after transplantation
Graft survival
Functional kidney graft at 7 days, 3, 6, and 12 months
Time frame: From 1-365 days after transplantation
Patient survival (censored and uncensored for death)
Patient survival at 7 days, 3, 6, and 12 months
Time frame: From 1-365 days after transplantation
Glomerular filtration rate at 1 year after transplantation
24-hour creatinine clearance
Time frame: At 1 year after transplantation (window 30 days)
Estimated glomerular filtration rate
eGFR defined by the CKD-EPI equation (Chronic Kidney Disease Epidemiology Collaboration) at 3, 6 and 12 months after transplantation
Time frame: At 3, 6, and 12 months after transplantation with window of 10 days
Primary non-function
defined as the continued need for dialysis at 3 months after transplantation
Time frame: Until 3 months after transplantation
Biopsy-proven acute rejection
Biopsy-proven acute rejection during the 1 year after transplantation
Time frame: Until 1 year after transplantation with window of 10 days
Metabolic analysis on kidney preservation tissue
Metabolic analysis by 1D proton NMR (e.g., succinate, lactate, acetate, formate, hypoxanthine) on a tissue sample taken before (= baseline) and at the end of the preservation period before transplantation of the kidney
Time frame: Baseline and pre-surgery
Metabolic analysis on kidney preservation tissue
Metabolic analysis by liquid chromatography coupled to electrospray ionization mass spectrometry (LC-ESI-MS) (succinate, glutamate, lactate, ATP, ADP, AMP, NADH, NAD+) on a tissue sample taken before (= baseline) and at the end of the preservation period before transplantation of the kidney
Time frame: Baseline and pre-surgery
Metabolic analysis on preservation fluid
Metabolic analysis by 1D proton NMR and fluorescence on a perfusion fluid sample taken before (= baseline) and at the end of the preservation period before transplantation of the kidney
Time frame: Baseline and pre-surgery
Plan to share: No
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Started Mar 2022 (actual). Primary completion is estimated for Jan 2025, 33 months after the start.
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Studies of the drug tested here: Oxygen
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