160 Participants NeededMy employer runs this trial

Furosemide vs Mannitol for Kidney Transplant

Recruiting at 1 trial location
CR
Overseen ByCadence Research Manager, BSc, MSc
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

Delayed graft function, defined as the need for dialysis within seven days of kidney transplantation, is a common complication affecting deceased-donor kidney transplant recipients. It is associated with prolonged hospitalization, increased healthcare costs, higher rates of acute rejection, and poorer long-term graft survival. Intraoperative diuretics are routinely administered during kidney transplant surgery to promote early urine output and protect the kidney from injury during reperfusion. The two most commonly used agents are furosemide and mannitol. Despite decades of clinical use, no prospective randomized trial has directly compared these two medications, and practice remains highly variable across centres and individual surgeons. This single-centre, prospective, randomized, surgeon-blinded pilot trial will enroll 240 deceased-donor kidney transplant recipients at London Health Sciences Centre. Participants will be randomized in a 1:1 ratio, stratified by donor type, to receive either intraoperative furosemide or intraoperative mannitol. The primary feasibility outcomes include recruitment rate. The primary clinical outcome is the incidence of delayed graft function. Secondary outcomes include serum creatinine trajectory, urine output, dialysis requirements, perioperative complications, length of stay, and one-year graft and patient survival. This pilot trial will provide feasibility data and effect-size estimates necessary to inform the design of a future definitive multicentre randomized controlled trial.

Are You a Good Fit for This Trial?

This trial is for adults over 18 who are scheduled to receive a kidney transplant from a deceased donor and can give informed consent (or have someone do so for them). People can't join if they're under 18, getting another organ at the same time, allergic to furosemide or mannitol, or already in this study.

Inclusion Criteria

I am older than 18 years.
I am scheduled to receive a kidney transplant from a deceased donor.
I am able and willing to give written consent, or my decision maker can sign for me.

Exclusion Criteria

Previously enrolled in this clinical trial
I am under 18 years old.
I am getting a kidney transplant along with another organ.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive intraoperative administration of either furosemide or mannitol during kidney transplantation

Intraoperative
1 visit (in-person)

Post-operative Monitoring

Participants are monitored for delayed graft function and other post-operative outcomes

7 days
Daily monitoring (in-person)

Follow-up

Participants are monitored for safety, effectiveness, and survival outcomes

1 year
Regular follow-up visits

What Are the Treatments Tested in This Trial?

Interventions

  • Furosemide
  • Mannitol

Trial Overview

The study compares two medications—furosemide and mannitol—given during kidney transplant surgery. Participants are randomly assigned to one of these drugs to see which better prevents delayed graft function after receiving a deceased-donor kidney.

How Is the Trial Designed?

2

Treatment groups

Active Control

Group I: FurosemideActive Control1 Intervention
Group II: MannitolActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Lead Sponsor

Trials
678
Recruited
421,000+