Intermittent Versus Continuous Surface O2 During HMP of DCD Kidneys

NCT05430620 | Recruiting Phase 3

• 1 other identifier: 2021/21MAI/239
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Hypothermic oxygenated machine perfusion; Kidney preservation; bubble and surface oxygenation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• Need for dialysis after transplantation

  0-30 days after transplantation

• Delayed graft function

  first 7 days after transplantation

• Serum creatinine reduction ratio

  Day 1-2 after transplantation

• Graft survival

  From 1-365 days after transplantation

• Patient survival (censored and uncensored for death)

  From 1-365 days after transplantation

Study Arms (2)

I-HMPO2

EXPERIMENTAL

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

Drug: Oxygen

C-HMPO2

ACTIVE COMPARATOR

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

Drug: Oxygen

Interventions

Oxygen 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

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

C-HMPO2; I-HMPO2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Multi-organ recipients
• Dual kidney transplantation

Sponsors & Collaborators

• Cliniques universitaires Saint-Luc- Université Catholique de Louvain: lead

Study Sites (1)

Cliniques Universitaires Saint-Luc

Brussels, Woluwé-Saint-Lambert, 1200, Belgium

RECRUITING

MeSH Terms

Conditions

Delayed Graft Function; Reperfusion Injury

Interventions

Oxygen

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases; Postoperative Complications

Intervention Hierarchy (Ancestors)

Chalcogens; Elements; Inorganic Chemicals; Gases

Study Officials

• Tom Darius, MD, PhD

  Cliniques universitaires Saint-Luc- Université Catholique de Louvain

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tom Darius, Phd

CONTACT

003227642218; tom.darius@saintluc.uclouvain.be

Nathalie Staumont

CONTACT

003227642218; nathalie.Staumont@saintluc.uclouvain.be

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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)

Study Record Dates

• First Submitted: June 17, 2022
• First Posted: June 24, 2022
• Study Start: March 20, 2022
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2026
• Last Updated: May 23, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)