Comparison of Two Techniques of Renal Pre-transplant Infusion on the Evolution of Renal Function in the Recipient

Completed

• Conditions: Transplantation; Kidney
• Interventions: Device: Waves perfusion device; Device: LifePort® perfusion device

• Registration Number: NCT02826213
• Lead Sponsor: University Hospital, Tours

Brief Summary

Comparison of two techniques of renal pre-transplant infusion on the evolution of renal function in the recipient: multicentre randomized trial

Detailed Description

Both machines differ in their operation: the LifePort® machine manufactured by the "Organ Recovery System (ORS)," says renal perfusion by maintaining a continuous perfusion pressure that is adjustable, while the Waves machine company "Medical Waters" assures infusion maintaining a controlled pulsatile flow.

Both machines are now available but the investigators currently have no study of whether an infusion type is superior to the other in terms of results on renal function recipients.

Study the impact of both types of infusion on renal function recipients evaluated in the early days of transplantation, at three months and one year after the transplant.

Study Timeline

• Study First Submitted: 2016-07-05
• Study First Submitted QC: 2016-07-05
• Study First Posted: 2016-07-07
• Study Start: 2017-11-29
• Primary Completion: 2021-03-01
• Study Completion: 2021-09-01
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-02
• Last Update Posted: 2022-11-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 228

Inclusion Criteria

• Deceased donor in brain-dead
• Donor presenting the expanded criteria of kidney removal (ECD criteria: elderly over 60 or aged 50 to 59 years and has two of the three following criteria: hypertension, stroke deaths, serum creatinine> 1.5 mg / dL)
• Possibility of both kidneys perfused machines
• Sampling of both kidneys, for two distinct recipients

Exclusion Criteria

• none

RENAL recipients:

The grafts are addressed to transplant centers in France according to the distribution rules of the National Center of Distribution of transplants . (Pôle National de Répartition des Greffons (PNRG).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Kidney : perfusion device waves	Waves perfusion device	Each donor (n=140) will provide one kidney for continuous perfusion.
Kidney : perfusion device lifeport	LifePort® perfusion device	Each donor (n=140) will provide one kidney for pulsatile perfusion.

Primary Outcome Measures

Name	Time	Method
Glomerular Filtration Rate	3 months	Rate of patients with a Glomerular Filtration Rate (GFR) calculated by the MDRD ≥ 45 ml / min / 1,73m² (considered normal in a renal graft) at 3 months post-transplantation (MDRD: Modification of Diet in Renal the Disease)

Secondary Outcome Measures

Name	Time	Method
RFG	1 month	Absence of a recovery renal function at 1 month.
Creatinine <250 mg / dL	1 week	Time for obtaining a serum creatinine \<250 mg / dL and need for dialysis in recovery during the first seven days post transplant.
MDRD	1 year	Modification of Diet in Renal the Disease at 1 year
GSR	1 year	graft survival rate at 1 year.
Renal Biopsie results	3 months	Results of analyzes of kidney biopsies punctures to 3 months.

Trial Locations

Locations (7)

Coordination des prélèvements d'organes et de Tissus- CHU-Limoges -CHU- DUPUYTREN; 🇫🇷 Limoges, France

Chirurgien-Chirurgie de la transplantation et d'Urologie, Pavillon V, Hôpital Edouard HERRIOT; 🇫🇷 Lyon, France

Coordination des prélèvements d'organes et de Tissus Pôle Anesthésie-Réanimations,University Hospital; 🇫🇷 Tours, France

Coordination des prélèvements d'organes et de Tissus,CHU-NANTES; 🇫🇷 Nantes, France

Coordination Hospitalière de PMO , Pôle USSAR-Anestéthésie -Réa CHU-ANGERS; 🇫🇷 Angers, France

Coordination Hospitalière de PMO-Anestésiste -réanimateur, CHU-Bordeaux -GROUPE HOSPITALIER PELLEGRIN DAR I; 🇫🇷 Bordeaux, France

CHD-Vendée-Les Oudairies; 🇫🇷 La Roche-sur-Yon, France