Clinical trial NCT05430620: Intermittent Versus Continuous Surface O2 During HMP of DCD Kidneys
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Delayed Graft Function
Kidney Transplant; Complications
Ischemia Reperfusion Injury
Mitochondrial
Keywords: Hypothermic oxygenated machine perfusion
Kidney preservation
bubble and surface oxygenation
Lead sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2022-06-24
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model 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)
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: Functional delayed graft function
timeFrame: first 7 days after transplantation
Secondary outcomes:
measure: Need for dialysis after transplantation
timeFrame: 0-30 days after transplantation
measure: Delayed graft function
timeFrame: first 7 days after transplantation
measure: Serum creatinine reduction ratio
timeFrame: Day 1-2 after transplantation
measure: Graft survival
timeFrame: From 1-365 days after transplantation
measure: Patient survival (censored and uncensored for death)
timeFrame: From 1-365 days after transplantation
measure: Glomerular filtration rate at 1 year after transplantation
timeFrame: At 1 year after transplantation (window 30 days)
measure: Estimated glomerular filtration rate
timeFrame: At 3, 6, and 12 months after transplantation with window of 10 days
measure: Primary non-function
timeFrame: Until 3 months after transplantation
measure: Biopsy-proven acute rejection
timeFrame: Until 1 year after transplantation with window of 10 days
measure: Metabolic analysis on kidney preservation tissue
timeFrame: Baseline and pre-surgery
measure: Metabolic analysis on kidney preservation tissue
timeFrame: Baseline and pre-surgery
measure: Metabolic analysis on preservation fluid
timeFrame: Baseline and pre-surgery
Other outcomes:
Locations:
city: Brussel
country: Belgium
facility: Cliniques Universitaires Saint-Luc
state: Woluwé-Saint-Lambert
Study officials:
affiliation: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
name: Tom Darius, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: