Recruiting

Furosemide vs. Mannitol

Sponsor:

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

Code:

NCT07726134

Conditions

Delayed Graft Function

Kidney Transplantation

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Furosemide

Mannitol

Study Details

Brief summary:

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.

Conditions

Delayed Graft Function

Kidney Transplantation

Study ID

NCT07726134

Start date

Sep, 2026

Status verified date

Sep, 2026

Completion date

Dec, 2028

Anticipated

Primary completion date

Aug, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Age >18 years;
2. Patient is scheduled to receive a deceased-donor kidney transplant (including both NDD and DCD donors)
3. Patient is willing and able to provide written and informed consent, or a substitute decision maker (SDM) is available to sign on the patient's behalf

Exclusion Criteria:

1. Patient is receiving another organ at the time of their kidney transplant (e.g., simultaneous kidney-pancreas or kidney-liver)
2. Known allergy or contraindication to mannitol or furosemide
3. Inability to provide informed consent
4. Pediatric recipients (<18 years of age)
5. Previously enrolled in this clinical trial

Study Design

Enrollment

160 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Furosemide

In the Furosemide arm, 80 mg IV will be administered at 10-15 minutes prior to reperfusion of the transplanted kidney.

active comparator: Mannitol

In the Mannitol arm, mannitol 0.5 g/kg IV will be administered at 10-15 minutes prior to reperfusion of the transplanted kidney.

Interventions

Furosemide

Furosemide is a potent loop diuretic that inhibits the sodium-potassium-2-chloride (Na+/K+/2Cl-) co-transporter (NKCC2) on the luminal surface of the thick ascending limb of the loop of Henle. By blocking this transporter, furosemide reduces sodium reabsorption, increases sodium and water delivery to the distal nephron, and produces a brisk natriuresis and diuresis. In participants randomized to the Furosemide arm, 80 mg IV will be administered at 10-15 minutes prior to reperfusion of the transplanted kidney.

Mannitol

Mannitol is a six-carbon sugar alcohol that is metabolically inert, freely filtered by the glomerulus, and largely unabsorbed by the renal tubules. It remains confined to the extracellular space and is excreted unchanged in the urine. As an osmotic diuretic, mannitol increases the osmolality of the glomerular filtrate, which opposes water reabsorption along the length of the nephron and produces dilute urine. In patients randomized to the Mannitol arm, mannitol 0.5 g/kg IV will be administered at 10-15 minutes prior to reperfusion of the transplanted kidney.

Primary outcome measure

  • Recruitment rate [ Time Frame: From enrollment to the end of the study (1 year) ]
  • Consent Rate [ Time Frame: From enrollment to the end of the study (1 year). ]
  • Protocol Adherence [ Time Frame: From enrollment to end of study (1 year) ]
  • Data Completeness [ Time Frame: From enrollment to end of study (1 year) ]
  • Delayed Graft Function (DGF) [ Time Frame: From the administration of study drug until the end of post-op day 7. ]

Central Contacts and Locations

Central contacts

Cadence Research Manager, BSc, MSc

(519) 685-8500Cadence.Baker@lhsc.on.ca

Locations

University Hospital - London Health Sciences Centre

Recruiting

London, Ontario, Canada, N6A 5A5

Contacts

Cadence Baker, BSc, MSc

5196858500Cadence.Baker@lhsc.on.ca

Principal Investigator:

Dr. Alp Sener, MD, PhD

More Information

Sponsor

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

Last update posted

Sep 18, 2026

Last verified

Sep, 2026

Keywords

  • Furosemide
  • Lasix
  • Mannitol
  • Intraoperative diuretics
  • Kidney transplantation
  • Renal transplantation
  • Deceased donor kidney transplantation
  • Delayed graft function
  • DGF
  • Early graft function
  • Ischemia-reperfusion injury
  • Kidney allograft

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-19. This information was provided to ClinicalTrials.gov by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's on 2026-09-18.