Delayed Renal Allograft Function and Furosemide Treatment

Withdrawn before enrolling · Phase 2 · Has a placebo group

Conditions studied: Delayed Graft Function

In brief

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.

Key facts

Study ID

NCT02312115

Run by

Loma Linda University

People needed

0

Starts

2016-09-01

Expected to finish

2016-10-01

Last updated by the study team

2016-11-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥ 18 years
• Patient with ESRD who has been on RRT (Hemodialysis or Peritoneal dialysis)
• Recipient of deceased donor kidney transplant
• Urine output less than 0.5 mL/kg/h before transplant
• Patient consents to the study
• Patient is not allergic to furosemide or sulfa
• English or Spanish speaking patient
• Patient is oliguric (urine output less than 0.5mL/kg/h, as per AKIN criteria) or anuric (urine output less than 10 mL in 6 hours post-transplant or 2 mL/h) in the first 6 hours post kidney transplant

You may not qualify if…

• Recipients of a living donor kidney transplant
• Patients who do not consent for the study
• Patients age <18 years
• Patients who are allergic to furosemide or sulfa containing medications
• Non-oliguric patients
• Patients who require immediate dialysis within 6 hours of the transplant (before enrollment)
• Patients with renal ischemia due to vascular compromise that has been confirmed with Doppler Ultrasound right after transplant as per standard of care
• Patients who return to the operating room due to complications within 24 hours
• Simultaneous multi-organ transplant recipients
• Hypotensive patients with BP <90/60 or MAP <60 mmHg
• Patients who are on vasopressors at any time during study period
• Non-English or Spanish speaking patient

Where it is running

• Loma Linda University Medical Center — Loma Linda, California, United States

Full record on ClinicalTrials.gov

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