Intermittent Versus Continuous Surface O2 During HMP of DCD Kidneys (HMPO2)

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Status and phase: Enrolling; Phase 3

Conditions: Mitochondrial; Kidney Transplant; Complications; Ischemia Reperfusion Injury; Delayed Graft Function

Treatments: Drug: Oxygen

Study type: Interventional

Funder types: Other

Identifiers

NCT05430620

2021/21MAI/239

Details and patient eligibility

About

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.

Full 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).

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

I-HMPO2

Experimental group

Description:

intermittent surface oxygenation during hypothermic machine perfusion (surface oxygenation interrupted during organ transport)

Treatment:

Drug: Oxygen

C-HMPO2

Active Comparator group

Description:

continuous surface oxygenation during HMP (surface oxygenation during the whole machine preservation period included organ transport)

Treatment:

Drug: Oxygen