Intermittent Versus Continuous Surface O2 During HMP of DCD Kidneys

Phase 3

Recruiting

• Conditions: Delayed Graft Function; Ischemia Reperfusion Injury; Kidney Transplant; Complications; Mitochondrial
• Interventions: Drug: Oxygen

• Registration Number: NCT05430620
• Lead Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

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 Timeline

• Study Start: 2022-03-20
• Study First Submitted: 2022-06-17
• Study First Submitted QC: 2022-06-23
• Study First Posted: 2022-06-24
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-22
• Last Update Posted: 2024-05-23
• Primary Completion: 2025-01-01
• Study Completion: 2026-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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.

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Exclusion Criteria

• Multi-organ recipients
• Dual kidney transplantation

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
C-HMPO2	Oxygen	continuous surface oxygenation during HMP (surface oxygenation during the whole machine preservation period included organ transport)
I-HMPO2	Oxygen	intermittent surface oxygenation during hypothermic machine perfusion (surface oxygenation interrupted during organ transport)

Primary Outcome Measures

Name	Time	Method
Functional delayed graft function	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 Outcome Measures

Name	Time	Method
Patient survival (censored and uncensored for death)	From 1-365 days after transplantation	Patient survival at 7 days, 3, 6, and 12 months
Glomerular filtration rate at 1 year after transplantation	At 1 year after transplantation (window 30 days)	24-hour creatinine clearance
Primary non-function	Until 3 months after transplantation	defined as the continued need for dialysis at 3 months after transplantation
Metabolic analysis on preservation fluid	Baseline and pre-surgery	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
Need for dialysis after transplantation	0-30 days after transplantation	Number of dialysis sessions after transplantation
Biopsy-proven acute rejection	Until 1 year after transplantation with window of 10 days	Biopsy-proven acute rejection during the 1 year after transplantation
Graft survival	From 1-365 days after transplantation	Functional kidney graft at 7 days, 3, 6, and 12 months
Estimated glomerular filtration rate	At 3, 6, and 12 months after transplantation with window of 10 days	eGFR defined by the CKD-EPI equation (Chronic Kidney Disease Epidemiology Collaboration) at 3, 6 and 12 months after transplantation
Delayed graft function	first 7 days after transplantation	defined as the need for dialysis in the first 7 days after transplantation and preceding the return of kidney function
Serum creatinine reduction ratio	Day 1-2 after transplantation	alternative definition of DGF= CRR2 \< or = 30%
Metabolic analysis on kidney preservation tissue	Baseline and pre-surgery	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

Trial Locations

Locations (1)

Cliniques Universitaires Saint-Luc; 🇧🇪 Brussel, Woluwé-Saint-Lambert, Belgium