Delayed Graft FunctionNCT07726134
The Impact of Intraoperative Diuretic Use on Delayed Graft Function Following Deceased Donor Renal Transplantation
A study testing Furosemide and Mannitol in people with Delayed Graft Function and Kidney Transplantation, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 2 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Delayed Graft Function, Kidney Transplantation
- What is being tested?
- Furosemide and Mannitol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 2 sitesCanada
- Study dates
- Sep 2026to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >18 years;
- Patient is scheduled to receive a deceased-donor kidney transplant (including both NDD and DCD donors)
- 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
Who cannot join
- Patient is receiving another organ at the time of their kidney transplant (e.g., simultaneous kidney-pancreas or kidney-liver)
- Known allergy or contraindication to mannitol or furosemide
- Inability to provide informed consent
- Pediatric recipients (<18 years of age)
- Previously enrolled in this clinical trial
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada2 sites, 2 recruiting
- Not yet recruiting
London Health Sciences Centre
London, Ontario, n6a 5a5
Cadence Research Manager, BSc, MSc, +15196858500 ext. 34769, Cadence.Baker@lhsc.on.ca
- Recruiting
University Hospital - London Health Sciences Centre
London, Ontario, N6A 5A5
Cadence Baker, BSc, MSc, 5196858500 ext. 34769, Cadence.Baker@lhsc.on.ca
Dr. Alp Sener, MD, PhD
About this study
Official title: A Pilot Randomized, Surgeon-blinded, Trial of Intraoperative Furosemide Versus Mannitol Among Deceased Donor Kidney Transplant Recipients
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.
Read the detailed description
Kidney transplantation has been the treatment of choice for end-stage renal disease for over six decades, yet delayed graft function (DGF) remains one of the most common and clinically significant complications of deceased-donor kidney transplantation. Defined as the requirement for at least one session of dialysis within the first seven days following transplantation, DGF affects 20-40% of deceased-donor kidney transplant recipients depending on the donor population and centre. DGF is associated with prolonged hospitalization, increased healthcare costs, a 1.4- to 2-fold increase in acute rejection risk, and inferior long-term graft survival. The pathophysiology centres on ischemia-reperfusion injury (IRI), which causes acute tubular necrosis, endothelial dysfunction, microvascular thrombosis, and upregulation of allograft immunogenicity through increased expression of MHC molecules and damage-associated molecular patterns. Donor type significantly influences DGF risk: donation after circulatory death (DCD) organs carry the highest historic rates due to sustained hypoperfusion and anaerobic metabolism during the agonal phase, while donation after neurological death (NDD) organs are affected by systemic inflammatory responses driven by loss of sympathetic regulation. Intraoperative diuretics, furosemide and mannitol, have been used for decades during reperfusion to enhance early urine output and mitigate IRI. Furosemide, a loop diuretic, inhibits the NKCC2 co-transporter in the thick ascending limb, reducing tubular metabolic oxygen demand, promoting tubular flushing, and stimulating renal prostaglandin-mediated vasodilation. Mannitol, an osmotic diuretic, maintains high tubular flow rates, reduces tubular cell swelling, acts as a hydroxyl radical scavenger, and promotes intrarenal vasodilation through prostaglandin and natriuretic peptide release. Despite these plausible mechanisms, the evidence supporting either agent remains weak. A comprehensive review by Sandal et al. (2018) found that the evidence supporting loop diuretics in preventing DGF was poor, with no data on patient survival identified. Schnuelle and van der Woude similarly concluded that loop diuretics had not been shown to affect DGF rates or improve outcomes. For mannitol, while van Valenberg et al. described its intraoperative use as "indispensable" based on early trial data, and a systematic review by van de Laar et al. (2021) suggested lower rates of DGF with mannitol use, that review emphasized significant limitations in evidence quality and heterogeneity. A randomized trial by Reiterer et al. evaluating mannitol versus placebo in 34 deceased-donor recipients found no significant effect on oxidation-reduction potential. A preclinical study by Bipat et al. demonstrated that mannitol preserved diuresis and creatinine clearance in a rabbit model of hypoxic kidneys, providing mechanistic support but not clinical confirmation. Current clinical practice is highly heterogeneous. A UK survey of 40 transplant surgeons from 18 centres revealed that 13 used no intraoperative diuretics, 10 used mannitol alone, 6 used furosemide alone, and 11 used a combination, underscoring the complete lack of consensus. A Canadian survey similarly demonstrated wide variation in practice patterns across transplant centres. Retrospective data from the investigators' centre suggest DGF rates of approximately 30% with furosemide and 22% with mannitol, but these non-randomized data preclude definitive conclusions. The existing literature is limited by small sample sizes, retrospective designs, inconsistent dosing protocols, heterogeneous patient populations, and the absence of standardized outcome definitions. No adequately powered, prospective, randomized trial has compared furosemide head-to-head against mannitol. Multiple reviews have concluded that well designed prospective randomized data are needed. This pilot trial addresses that evidence gap by providing the first direct, randomized, blinded comparison of these two agents with standardized dosing and timing, generating feasibility data, effect-size estimates, and operational infrastructure to support a future definitive multicentre trial.
- Conditions
- Delayed Graft Function, Kidney Transplantation
- Being tested
- Furosemide, Mannitol
- 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
- Medical subject headings
- Delayed Graft Function, Reperfusion Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FurosemideDrug
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.
MannitolDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Furosemide | Active comparator | In the Furosemide arm, 80 mg IV will be administered at 10-15 minutes prior to reperfusion of the transplanted kidney. Receives: Drug: Furosemide |
| Mannitol | Active comparator | In the Mannitol arm, mannitol 0.5 g/kg IV will be administered at 10-15 minutes prior to reperfusion of the transplanted kidney. Receives: Drug: Mannitol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rate
Proportion of eligible patients who were approached and consented to enroll. Recruitment rate = number enrolled ÷ number of eligible patients screened. Reported as a percentage.
Measured: From enrollment to the end of the study (1 year)
Consent Rate
Consent rate = number who consented ÷ number approached. Reported as a percentage.
Measured: From enrollment to the end of the study (1 year).
Protocol Adherence
Proportion of study drug administrations (Lasix or Mannitol) delivered in accordance with the protocol, defined as correct dose given within the protocol specified time window.
Measured: From enrollment to end of study (1 year)
Data Completeness
Proportion of expected data points that were successfully collected for the key outcome variables (e.g., DGF status, serum creatinine, urine output, and other pre-specified outcomes). Calculated as the number of data points collected ÷ number of data points expected per protocol, across all enrolled participants. Reported as a percentage.
Measured: From enrollment to end of study (1 year)
Delayed Graft Function (DGF)
Defined as the requirement for at least one session of dialysis within the first seven days following kidney transplantation. This is a dichotomous outcome assessed at day 7 post-transplant (yes/no).
Measured: From the administration of study drug until the end of post-op day 7.
Secondary outcomes (4)
Early graft function
- To compare early graft function between groups, as measured by urine output in the first 24-72 hours, serum creatinine levels during postoperative days 1-7.
Measured: From the time of enrollment up until post op day 7.
Postoperative dialysis requirement
- To compare postoperative dialysis requirements, including number and duration of dialysis sessions.
Measured: Post-op day 0 until the end of enrollment (1 year)
Post-operative Outcomes
- To evaluate the incidence of perioperative complications, including electrolyte abnormalities, hypotension requiring vasopressor support, pulmonary edema, transfusion requirements, biopsy-proven rejection, and 30-day readmission
Measured: Post-op day 0 until the end of post-op day 30
Survival
- To compare length of hospital stay and 1-year graft and patient survival between groups.
Measured: Post-op day 0 up until post-op day 365 (1 year post enrollment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2026
- Study startSep 2026 (estimated)
- Primary completionAug 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for Delayed Graft FunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alp Sener, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07726134
- Sponsor's protocol ID
- 16816
- Other IDs
- AHSC AFP Innovation Fund
- Status last verified
- Sep 2026
- First submitted
- 14 Jul 2026
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data are not currently planned to be shared with researchers outside the study team. Any future sharing of deidentified data would require approval from the research ethics board and all applicable institutional and privacy approvals.
Publications
Levine MA, Luke PP, Sener A. Canadian survey on the rates of use of intraoperative diuretics and justification for their use during renal allograft reperfusion. Can J Surg. 2020 Sep-Oct;63(5):E483-E488. doi: 10.1503/cjs.016019.
PubMed 33107815Reiterer C, Hu K, Sljivic S, Falkner von Sonnenburg M, Fleischmann E, Kabon B. The effect of mannitol on oxidation-reduction potential in patients undergoing deceased donor renal transplantation-A randomized controlled trial. Acta Anaesthesiol Scand. 2021 Feb;65(2):162-168. doi: 10.1111/aas.13713. Epub 2020 Oct 15.
PubMed 32966587van Valenberg PL, Hoitsma AJ, Tiggeler RG, Berden JH, van Lier HJ, Koene RA. Mannitol as an indispensable constituent of an intraoperative hydration protocol for the prevention of acute renal failure after renal cadaveric transplantation. Transplantation. 1987 Dec;44(6):784-8. doi: 10.1097/00007890-198712000-00012.
PubMed 3122381Bipat R, Steels P, Cuypers Y, Toelsie JR. Mannitol Reduces the Hydrostatic Pressure in the Proximal Tubule of the Isolated Blood-Perfused Rabbit Kidney during Hypoxic Stress and Improves Its Function. Nephron Extra. 2011 Jan;1(1):201-11. doi: 10.1159/000333478. Epub 2011 Nov 4.
PubMed 22470393Waskowski J, Pfortmueller CA, Erdoes G, Buehlmann R, Messmer AS, Luedi MM, Schmidli J, Schefold JC. Mannitol for the Prevention of Peri-Operative Acute Kidney Injury: A Systematic Review. Eur J Vasc Endovasc Surg. 2019 Jul;58(1):130-140. doi: 10.1016/j.ejvs.2019.02.003. Epub 2019 May 9.
PubMed 31078413Schnuelle P, Johannes van der Woude F. Perioperative fluid management in renal transplantation: a narrative review of the literature. Transpl Int. 2006 Dec;19(12):947-59. doi: 10.1111/j.1432-2277.2006.00356.x.
PubMed 17081224McMahon BA, Koyner JL, Novick T, Menez S, Moran RA, Lonze BE, Desai N, Alasfar S, Borja M, Merritt WT, Ariyo P, Chawla LS, Kraus E. The prognostic value of the furosemide stress test in predicting delayed graft function following deceased donor kidney transplantation. Biomarkers. 2018 Feb;23(1):61-69. doi: 10.1080/1354750X.2017.1387934. Epub 2017 Oct 16.
PubMed 29034718Sandal S, Bansal P, Cantarovich M. The evidence and rationale for the perioperative use of loop diuretics during kidney transplantation: A comprehensive review. Transplant Rev (Orlando). 2018 Apr;32(2):92-101. doi: 10.1016/j.trre.2017.11.002. Epub 2017 Nov 23.
PubMed 29242033Tiggeler RG, Berden JH, Hoitsma AJ, Koene RA. Prevention of acute tubular necrosis in cadaveric kidney transplantation by the combined use of mannitol and moderate hydration. Ann Surg. 1985 Feb;201(2):246-51. doi: 10.1097/00000658-198502000-00020.
PubMed 3918517Iguchi N, Lankadeva YR, Mori TA, Osawa EA, Cutuli SL, Evans RG, Bellomo R, May CN. Furosemide reverses medullary tissue hypoxia in ovine septic acute kidney injury. Am J Physiol Regul Integr Comp Physiol. 2019 Aug 1;317(2):R232-R239. doi: 10.1152/ajpregu.00371.2018. Epub 2019 May 29.
PubMed 31141418Kim DW, Tsapepas D, King KL, Husain SA, Corvino FA, Dillon A, Wang W, Mayne TJ, Mohan S. Financial impact of delayed graft function in kidney transplantation. Clin Transplant. 2020 Oct;34(10):e14022. doi: 10.1111/ctr.14022. Epub 2020 Aug 11.
PubMed 32573812Wu WK, Famure O, Li Y, Kim SJ. Delayed graft function and the risk of acute rejection in the modern era of kidney transplantation. Kidney Int. 2015 Oct;88(4):851-8. doi: 10.1038/ki.2015.190. Epub 2015 Jun 24.
PubMed 26108067Zhao H, Alam A, Soo AP, George AJT, Ma D. Ischemia-Reperfusion Injury Reduces Long Term Renal Graft Survival: Mechanism and Beyond. EBioMedicine. 2018 Feb;28:31-42. doi: 10.1016/j.ebiom.2018.01.025. Epub 2018 Feb 2.
PubMed 29398595Irish WD, Ilsley JN, Schnitzler MA, Feng S, Brennan DC. A risk prediction model for delayed graft function in the current era of deceased donor renal transplantation. Am J Transplant. 2010 Oct;10(10):2279-86. doi: 10.1111/j.1600-6143.2010.03179.x.
PubMed 20883559Belzer FO, Southard JH. Principles of solid-organ preservation by cold storage. Transplantation. 1988 Apr;45(4):673-6. doi: 10.1097/00007890-198804000-00001. No abstract available.
PubMed 3282347
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Randomized, Surgeon-blinded, Trial of Intraoperative Furosemide Versus Mannitol Among Deceased Donor Kidney Transplant Recipients
- ClinicalTrials.gov ID
- NCT07726134
- Acronym / sponsor ID
- 16816
- Conditions
- Delayed Graft Function, Kidney Transplantation
- Keywords
- Furosemide, Lasix, Mannitol, Intraoperative diuretics, Kidney transplantation, Renal transplantation, Deceased donor kidney transplantation, Delayed graft function
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Aug 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 24 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Kidney transplantation has been the treatment of choice for end-stage renal disease for over six decades, yet delayed graft function (DGF) remains one of the most common and clinically significant complications of deceased-donor kidney transplantation. Defined as the requirement for at least one session of dialysis within the first seven days following transplantation, DGF affects 20-40% of deceased-donor kidney transplant recipients depending on the donor population and centre. DGF is associated with prolonged hospitalization, increased healthcare costs, a 1.4- to 2-fold increase in acute rejection risk, and inferior long-term graft survival. The pathophysiology centres on ischemia-reperfusion injury (IRI), which causes acute tubular necrosis, endothelial dysfunction, microvascular thrombosis, and upregulation of allograft immunogenicity through increased expression of MHC molecules and damage-associated molecular patterns. Donor type significantly influences DGF risk: donation after circulatory death (DCD) organs carry the highest historic rates due to sustained hypoperfusion and anaerobic metabolism during the agonal phase, while donation after neurological death (NDD) organs are affected by systemic inflammatory responses driven by loss of sympathetic regulation. Intraoperative diuretics, furosemide and mannitol, have been used for decades during reperfusion to enhance early urine output and mitigate IRI. Furosemide, a loop diuretic, inhibits the NKCC2 co-transporter in the thick ascending limb, reducing tubular metabolic oxygen demand, promoting tubular flushing, and stimulating renal prostaglandin-mediated vasodilation. Mannitol, an osmotic diuretic, maintains high tubular flow rates, reduces tubular cell swelling, acts as a hydroxyl radical scavenger, and promotes intrarenal vasodilation through prostaglandin and natriuretic peptide release. Despite these plausible mechanisms, the evidence supporting either agent remains weak. A comprehensive review by Sandal et al. (2018) found that the evidence supporting loop diuretics in preventing DGF was poor, with no data on patient survival identified. Schnuelle and van der Woude similarly concluded that loop diuretics had not been shown to affect DGF rates or improve outcomes. For mannitol, while van Valenberg et al. described its intraoperative use as "indispensable" based on early trial data, and a systematic review by van de Laar et al. (2021) suggested lower rates of DGF with mannitol use, that review emphasized significant limitations in evidence quality and heterogeneity. A randomized trial by Reiterer et al. evaluating mannitol versus placebo in 34 deceased-donor recipients found no significant effect on oxidation-reduction potential. A preclinical study by Bipat et al. demonstrated that mannitol preserved diuresis and creatinine clearance in a rabbit model of hypoxic kidneys, providing mechanistic support but not clinical confirmation. Current clinical practice is highly heterogeneous. A UK survey of 40 transplant surgeons from 18 centres revealed that 13 used no intraoperative diuretics, 10 used mannitol alone, 6 used furosemide alone, and 11 used a combination, underscoring the complete lack of consensus. A Canadian survey similarly demonstrated wide variation in practice patterns across transplant centres. Retrospective data from the investigators' centre suggest DGF rates of approximately 30% with furosemide and 22% with mannitol, but these non-randomized data preclude definitive conclusions. The existing literature is limited by small sample sizes, retrospective designs, inconsistent dosing protocols, heterogeneous patient populations, and the absence of standardized outcome definitions. No adequately powered, prospective, randomized trial has compared furosemide head-to-head against mannitol. Multiple reviews have concluded that well designed prospective randomized data are needed. This pilot trial addresses that evidence gap by providing the first direct, randomized, blinded comparison of these two agents with standardized dosing and timing, generating feasibility data, effect-size estimates, and operational infrastructure to support a future definitive multicentre trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Furosemide | Active comparator | Drug: FurosemideIn the Furosemide arm, 80 mg IV will be administered at 10-15 minutes prior to reperfusion of the transplanted kidney. |
| Mannitol | Active comparator | Drug: MannitolIn the Mannitol arm, mannitol 0.5 g/kg IV will be administered at 10-15 minutes prior to reperfusion of the transplanted kidney. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age >18 years;
- Patient is scheduled to receive a deceased-donor kidney transplant (including both NDD and DCD donors)
- 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
Key exclusion criteria (5 listed)
- Patient is receiving another organ at the time of their kidney transplant (e.g., simultaneous kidney-pancreas or kidney-liver)
- Known allergy or contraindication to mannitol or furosemide
- Inability to provide informed consent
- Pediatric recipients (<18 years of age)
- Previously enrolled in this clinical trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FurosemideFurosemide 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. | Drug | Furosemide |
| MannitolMannitol 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. | Drug | Mannitol |
Primary outcome
Recruitment rate
Time frame: From enrollment to the end of the study (1 year)
Proportion of eligible patients who were approached and consented to enroll. Recruitment rate = number enrolled ÷ number of eligible patients screened. Reported as a percentage.
Consent Rate
Time frame: From enrollment to the end of the study (1 year).
Consent rate = number who consented ÷ number approached. Reported as a percentage.
Protocol Adherence
Time frame: From enrollment to end of study (1 year)
Proportion of study drug administrations (Lasix or Mannitol) delivered in accordance with the protocol, defined as correct dose given within the protocol specified time window.
Data Completeness
Time frame: From enrollment to end of study (1 year)
Proportion of expected data points that were successfully collected for the key outcome variables (e.g., DGF status, serum creatinine, urine output, and other pre-specified outcomes). Calculated as the number of data points collected ÷ number of data points expected per protocol, across all enrolled participants. Reported as a percentage.
Delayed Graft Function (DGF)
Time frame: From the administration of study drug until the end of post-op day 7.
Defined as the requirement for at least one session of dialysis within the first seven days following kidney transplantation. This is a dichotomous outcome assessed at day 7 post-transplant (yes/no).
4 secondary outcomes
Early graft function
Time frame: From the time of enrollment up until post op day 7.
Postoperative dialysis requirement
Time frame: Post-op day 0 until the end of enrollment (1 year)
Post-operative Outcomes
Time frame: Post-op day 0 until the end of post-op day 30
Survival
Time frame: Post-op day 0 up until post-op day 365 (1 year post enrollment)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
- Background: PubMed 33107815Levine MA, Luke PP, Sener A. Canadian survey on the rates of use of intraoperative diuretics and justification for their use during renal allograft reperfusion. Can J Surg. 2020 Sep-Oct;63(5):E483-E488. doi: 10.1503/cjs.016019.
- Background: PubMed 32966587Reiterer C, Hu K, Sljivic S, Falkner von Sonnenburg M, Fleischmann E, Kabon B. The effect of mannitol on oxidation-reduction potential in patients undergoing deceased donor renal transplantation-A randomized controlled trial. Acta Anaesthesiol Scand. 2021 Feb;65(2):162-168. doi: 10.1111/aas.13713. Epub 2020 Oct 15.
- Background: PubMed 3122381van Valenberg PL, Hoitsma AJ, Tiggeler RG, Berden JH, van Lier HJ, Koene RA. Mannitol as an indispensable constituent of an intraoperative hydration protocol for the prevention of acute renal failure after renal cadaveric transplantation. Transplantation. 1987 Dec;44(6):784-8. doi: 10.1097/00007890-198712000-00012.
- Background: PubMed 22470393Bipat R, Steels P, Cuypers Y, Toelsie JR. Mannitol Reduces the Hydrostatic Pressure in the Proximal Tubule of the Isolated Blood-Perfused Rabbit Kidney during Hypoxic Stress and Improves Its Function. Nephron Extra. 2011 Jan;1(1):201-11. doi: 10.1159/000333478. Epub 2011 Nov 4.
- Background: PubMed 31078413Waskowski J, Pfortmueller CA, Erdoes G, Buehlmann R, Messmer AS, Luedi MM, Schmidli J, Schefold JC. Mannitol for the Prevention of Peri-Operative Acute Kidney Injury: A Systematic Review. Eur J Vasc Endovasc Surg. 2019 Jul;58(1):130-140. doi: 10.1016/j.ejvs.2019.02.003. Epub 2019 May 9.
- Background: PubMed 17081224Schnuelle P, Johannes van der Woude F. Perioperative fluid management in renal transplantation: a narrative review of the literature. Transpl Int. 2006 Dec;19(12):947-59. doi: 10.1111/j.1432-2277.2006.00356.x.
- Background: PubMed 29034718McMahon BA, Koyner JL, Novick T, Menez S, Moran RA, Lonze BE, Desai N, Alasfar S, Borja M, Merritt WT, Ariyo P, Chawla LS, Kraus E. The prognostic value of the furosemide stress test in predicting delayed graft function following deceased donor kidney transplantation. Biomarkers. 2018 Feb;23(1):61-69. doi: 10.1080/1354750X.2017.1387934. Epub 2017 Oct 16.
- Background: PubMed 29242033Sandal S, Bansal P, Cantarovich M. The evidence and rationale for the perioperative use of loop diuretics during kidney transplantation: A comprehensive review. Transplant Rev (Orlando). 2018 Apr;32(2):92-101. doi: 10.1016/j.trre.2017.11.002. Epub 2017 Nov 23.
- Background: PubMed 3918517Tiggeler RG, Berden JH, Hoitsma AJ, Koene RA. Prevention of acute tubular necrosis in cadaveric kidney transplantation by the combined use of mannitol and moderate hydration. Ann Surg. 1985 Feb;201(2):246-51. doi: 10.1097/00000658-198502000-00020.
- Background: PubMed 31141418Iguchi N, Lankadeva YR, Mori TA, Osawa EA, Cutuli SL, Evans RG, Bellomo R, May CN. Furosemide reverses medullary tissue hypoxia in ovine septic acute kidney injury. Am J Physiol Regul Integr Comp Physiol. 2019 Aug 1;317(2):R232-R239. doi: 10.1152/ajpregu.00371.2018. Epub 2019 May 29.
- Background: PubMed 32573812Kim DW, Tsapepas D, King KL, Husain SA, Corvino FA, Dillon A, Wang W, Mayne TJ, Mohan S. Financial impact of delayed graft function in kidney transplantation. Clin Transplant. 2020 Oct;34(10):e14022. doi: 10.1111/ctr.14022. Epub 2020 Aug 11.
- Background: PubMed 26108067Wu WK, Famure O, Li Y, Kim SJ. Delayed graft function and the risk of acute rejection in the modern era of kidney transplantation. Kidney Int. 2015 Oct;88(4):851-8. doi: 10.1038/ki.2015.190. Epub 2015 Jun 24.
- Individual participant dataSharing planned: No. Individual participant data are not currently planned to be shared with researchers outside the study team. Any future sharing of deidentified data would require approval from the research ethics board and all applicable institutional and privacy approvals.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Furosemide and Mannitol in people with Delayed Graft Function and Kidney Transplantation, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cadence Research Manager, BSc, MSc ((519) 685-8500 ext. 34769, Cadence.Baker@lhsc.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rate (time frame: From enrollment to the end of the study (1 year)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07726134, which also lists 24 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2026.