Clinical Trial: Delayed Renal Allograft Function and Furosemide Treatment

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

Official Title: DRAFFT Trial: Delayed Renal Allograft Function and Furosemide Treatment: A Randomized Prospective Double-blinded Placebo-controlled Clinical Pilot Trial

Brief Summary: This study will be a randomized prospective double-blind placebo-controlled clinical pilot trial. This will be a single center project that will take place at Loma Linda University Medical Center. All adult kidney recipients will be informed of the study prior to operation. The Nephrology fellows or attending physicians will attempt to obtain informed consent from all eligible patients, pre-transplant. Those patients who consent will be screened post operation for enrollment. Patients who do not meet all eligibility criteria and/or who meet some exclusion criteria will be deemed ineligible for the trial, and will be excluded. The Nephrology and Transplant teams will be blinded of patient assignment and only the pharmacy will know the patient's assignment.

Detailed Summary:

  1. Background/ Rationale Kidney Transplantation is a lifesaving modality in patients with end-stage renal disease (ESRD), and the numbers of transplants have been skyrocketing since the first successful trials. In 2013 alone, there were over 18,000 kidney transplants done in the United States of America. Of those, 11,161 were from a deceased donor (NKUDIC 2011, One Legacy 2014, USRDS 2013). One common complication of renal transplants is Delayed Graft Function (DGF). DGF is a serious complication, which is best defined as the need for renal replacement therapy, such as dialysis, within the first week after renal transplant (Mallon et al. 2013). DGF greatly increases the risk of acute and chronic transplant rejection, which decreases patient survival and quality of life, for those patients who do survive (Perico et al. 2004, Weber et al. 2014). Additionally, the rate of DGF is highest in patients who have received deceased donor transplants (One Legacy 2014). Therefore, it is crucial to the well-being of this large population to reduce the incidence of DGF. Our approach is to investigate current treatment modalities for patients post-deceased donor renal transplant, to understand how best to prevent DGF before it even starts. Currently, administration of loop diuretics such as furosemide is a common practice in order to prevent and treat oliguria in renal transplant patients. However, only animal models have been able to show a benefit in treating acute kidney injury (AKI), which occurs in the transplant kidney due to cold ischemia time, with furosemide. There is a lack of evidence that furosemide use leads to improved patient outcomes in patients with AKI (Nadeau-Fredette et al. 2013). Given that side effects of furosemide administration include ototoxicity, hypotension, electrolyte abnormalities, and hypersensitivity reactions, and the investigators hypothesize, may not significantly reduce
    Sponsor: Loma Linda University

    Current Primary Outcome: The percent of participants receiving a deceased donor kidney that develop Delayed Graft Function (DGF), defined as the need to undergo Renal Replacement Therapy (RRT) within the first seven days after renal transplant. [ Time Frame: 7 Days ]

    Original Primary Outcome: Same as current

    Current Secondary Outcome:

    • 30-day, 90-day and 12-month creatinine levels and estimated Glomerular Filtration Rate (eGFR) [ Time Frame: 30 days, 90 days and 12 months post-transplant ]
    • The need for Renal Replacement Therapy (RRT) 30 days, 90 days and 12 months post-transplant [ Time Frame: 30 days, 90 days and 12 months post-transplant ]
    • The time from transplant to Delayed Graft Function (DGF) development [ Time Frame: 24 hours ]
    • The incidence of Delayed Graft Function (DGF) [ Time Frame: 24 Hours ]
    • The incidence of primary graft non-function [ Time Frame: 12 months ]
    • Overall hospital length of stay [ Time Frame: 30 days ]
    • The Kidney Profile Donor Index (KDPI) score in relation to primary graft non-function [ Time Frame: 12 months ]


    Original Secondary Outcome: Same as current

    Information By: Loma Linda University

    Dates:
    Date Received: November 25, 2014
    Date Started: September 2016
    Date Completion:
    Last Updated: November 23, 2016
    Last Verified: November 2016