Intermittent Versus Continuous Surface O2 During HMP of DCD Kidneys

Kidney Transplant; Complications Clinical Trial

— HMPO2  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05430620
• Other study ID #: 2021/21MAI/239
• Status: Recruiting
• Phase: Phase 3
• Start date: March 20, 2022
• Est. completion date: January 1, 2026

Study information

• Verified date: May 2024
• Source: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• Contact: Tom Darius, Phd
• Phone: 003227642218
• Email: tom.darius[@]saintluc.uclouvain.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: January 1, 2026
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Delayed Graft Function
• Ischemia Reperfusion Injury
• Kidney Transplant; Complications
• Reperfusion Injury

Intervention

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

Locations

Country	Name	City	State
Belgium	Cliniques Universitaires Saint-Luc	Brussel	Woluwé-Saint-Lambert

Sponsors (1)

Lead Sponsor	Collaborator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Country where clinical trial is conducted

Belgium, 

Outcome

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