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Mannitol Use During Cadaveric Kidney Transplantation

NCT04705402 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2021-01-22

No results posted yet for this study

Summary

We propose a placebo controlled randomized study on the use of mannitol as an agent to protect against delayed graft function, during the surgical procedure of kidney transplantation from a cadaver. Patients undergoing kidney transplantation for the treatment of end stage kidney disease will be randomized in a ratio of 1:1 to receive either intravenous mannitol or saline during their procedure, administered prior to renal artery clamp release and reperfusion of the kidney. Changes in renal function following surgery and the incidence and duration of delayed graft function (DGF) will be monitored using calculated glomerular filtration rate (eGFR) and the need for dialysis performed post-operatively, as part of routine standard of care. Additionally biological samples will be collected and analyzed for use of a non invasive biomarker for delayed graft function.

Conditions

  • Renal Dialysis

Interventions

DRUG

Mannitol

Mannitol (Israeli Brand Name: Osmitrol) is in the osmotic diuretic pharmacologic categoryaccording to the American Hospital Formulary Service (AHFS) database. . During the procedure, volume of 2.8 cc / kg body weight of the solution bag (either mannitol or saline 0.9%) will be given. The bag itself will be covered so it cannot be identified which solution is in it and marked per patient. Mannitol is injected by intravenous infusion using an I-vac pump and infused over 15 minutes.

DRUG

Saline

Study participants randomized to this arm will receive a 0.9% saline solution at a dose of 2.8 cc / kg, infused within 15-30 minutes prior to renal artery reperfusion through an existing intravenous access catheter (either through an central or peripheral intravenous infusion).

Sponsors & Collaborators

  • Rabin Medical Center

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-28
Primary Completion
2022-02-28
Completion
2022-02-28

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04705402 on ClinicalTrials.gov