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

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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)

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

Trial contacts and locations

1

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Central trial contact

Tom Darius, Phd; Nathalie Staumont

Data sourced from clinicaltrials.gov

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