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

Transplantation Clinical Trial

— RENOMAP  

Official title:

Comparison of Two Techniques of Renal Pre-transplant Infusion on the Evolution of Renal Function in the Recipient: Multicentre Randomized Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02826213
• Other study ID #: PHRI14-JCV-RENOMAP
• Status: Completed
• Start date: November 29, 2017
• Est. completion date: September 1, 2021

Study information

• Verified date: November 2022
• Source: University Hospital, Tours
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 228
• Est. completion date: September 1, 2021
• Est. primary completion date: March 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

RENAL Donors:

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).

Related Conditions & MeSH terms

• Kidney
• Transplantation

Intervention

Device:
• LifePort® perfusion device
Renal Perfusion with LifePort® perfusion device
• Waves perfusion device
Renal Perfusion with Waves perfusion device

Locations

Country	Name	City	State
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	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,CHU-NANTES	Nantes
France	Coordination des prélèvements d'organes et de Tissus Pôle Anesthésie-Réanimations,University Hospital	Tours

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Tours

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glomerular Filtration Rate	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)	3 months
Secondary	Creatinine <250 mg / dL	Time for obtaining a serum creatinine <250 mg / dL and need for dialysis in recovery during the first seven days post transplant.	1 week
Secondary	RFG	Absence of a recovery renal function at 1 month.	1 month
Secondary	MDRD	Modification of Diet in Renal the Disease at 1 year	1 year
Secondary	GSR	graft survival rate at 1 year.	1 year
Secondary	Renal Biopsie results	Results of analyzes of kidney biopsies punctures to 3 months.	3 months