Delayed Renal Allograft Function and Furosemide Treatment (NCT02312115) | Clinical Trial Compass
WithdrawnPhase 2
Delayed Renal Allograft Function and Furosemide Treatment
Stopped: Lack of funding
United States0Started 2016-09
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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.