Intermittent Versus Continuous Surface O2 During HMP of DCD Kidneys

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-20

Study Completion Date

2026-01-01

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Delayed Graft Function Kidney Transplant; Complications Ischemia Reperfusion Injury Mitochondrial

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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I-HMPO2

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

Group Type EXPERIMENTAL

Oxygen

Intervention Type DRUG

Active oxygenation during hypothermic machine perfusion by bubble and surface oxygenation. Intermittent surface oxygenation is compared with continuous surface oxygenation during hypothermic machine perfusion

C-HMPO2

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

Group Type ACTIVE_COMPARATOR

Oxygen

Intervention Type DRUG

Active oxygenation during hypothermic machine perfusion by bubble and surface oxygenation. Intermittent surface oxygenation is compared with continuous surface oxygenation during hypothermic machine perfusion

Interventions

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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

Intervention Type DRUG

Other Intervention Names

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feasibility of bubble and surface oxygenation applied to the LifePort Kidney Transporter (Organ Recovery Systems, Diegem, Belgium)

Eligibility Criteria

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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.