- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT07726134
The Impact of Intraoperative Diuretic Use on Delayed Graft Function Following Deceased Donor Renal Transplantation
15 de setembro de 2026 atualizado por: Alp Sener, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
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.
Visão geral do estudo
Status
Recrutamento
Condições
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Intervencional
Inscrição (Estimado)
160
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Cadence Research Manager, BSc, MSc
- Número de telefone: 34769 (519) 685-8500
- E-mail: Cadence.Baker@lhsc.on.ca
Locais de estudo
-
-
Ontario
-
London, Ontario, Canadá, N6A 5A5
- Recrutamento
- University Hospital - London Health Sciences Centre
-
Contato:
- Cadence Baker, BSc, MSc
- Número de telefone: 34769 5196858500
- E-mail: Cadence.Baker@lhsc.on.ca
-
Investigador principal:
- Dr. Alp Sener, MD, PhD
-
London, Ontario, Canadá, n6a 5a5
- Ainda não está recrutando
- London Health Sciences Centre
-
Contato:
- Cadence Research Manager, BSc, MSc
- Número de telefone: 34769 +15196858500
- E-mail: Cadence.Baker@lhsc.on.ca
-
-
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Descrição
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Comparador Ativo: Furosemide
In the Furosemide arm, 80 mg IV will be administered at 10-15 minutes prior to reperfusion of the transplanted kidney.
|
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.
|
|
Comparador Ativo: 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.
|
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.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Recruitment rate
Prazo: 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.
|
From enrollment to the end of the study (1 year)
|
|
Consent Rate
Prazo: From enrollment to the end of the study (1 year).
|
Consent rate = number who consented ÷ number approached.
Reported as a percentage.
|
From enrollment to the end of the study (1 year).
|
|
Protocol Adherence
Prazo: 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.
|
From enrollment to end of study (1 year)
|
|
Data Completeness
Prazo: 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.
|
From enrollment to end of study (1 year)
|
|
Delayed Graft Function (DGF)
Prazo: 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).
|
From the administration of study drug until the end of post-op day 7.
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Early graft function
Prazo: From the time of enrollment up until post op day 7.
|
1. 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.
|
From the time of enrollment up until post op day 7.
|
|
Postoperative dialysis requirement
Prazo: Post-op day 0 until the end of enrollment (1 year)
|
2. To compare postoperative dialysis requirements, including number and duration of dialysis sessions.
|
Post-op day 0 until the end of enrollment (1 year)
|
|
Post-operative Outcomes
Prazo: Post-op day 0 until the end of post-op day 30
|
3. 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
|
Post-op day 0 until the end of post-op day 30
|
|
Survival
Prazo: Post-op day 0 up until post-op day 365 (1 year post enrollment)
|
4. To compare length of hospital stay and 1-year graft and patient survival between groups.
|
Post-op day 0 up until post-op day 365 (1 year post enrollment)
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Publicações Gerais
- Belzer 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.
- Tiggeler 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.
- Siedlecki A, Irish W, Brennan DC. Delayed graft function in the kidney transplant. Am J Transplant. 2011 Nov;11(11):2279-96. doi: 10.1111/j.1600-6143.2011.03754.x. Epub 2011 Sep 19.
- Perico N, Cattaneo D, Sayegh MH, Remuzzi G. Delayed graft function in kidney transplantation. Lancet. 2004 Nov 13-19;364(9447):1814-27. doi: 10.1016/S0140-6736(04)17406-0.
- Schnuelle 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.
- 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.
- Reiterer 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.
- van 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.
- Bipat 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.
- Waskowski 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.
- McMahon 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.
- Sandal 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.
- Iguchi 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.
- Kim 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.
- Wu 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.
- Zhao 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.
- Irish 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.
- Laar SCV, Schouten GN, IJzermans JNM, Minnee RC. Effect of Mannitol on Kidney Function After Kidney Transplantation: A Systematic Review and Meta-Analysis. Transplant Proc. 2021 Sep;53(7):2122-2132. doi: 10.1016/j.transproceed.2021.07.001. Epub 2021 Aug 16.
- Snoeijs MG, Winkens B, Heemskerk MB, Hoitsma AJ, Christiaans MH, Buurman WA, van Heurn LW. Kidney transplantation from donors after cardiac death: a 25-year experience. Transplantation. 2010 Nov 27;90(10):1106-12. doi: 10.1097/TP.0b013e3181f83b0b.
- Thuillier R, Favreau F, Celhay O, Macchi L, Milin S, Hauet T. Thrombin inhibition during kidney ischemia-reperfusion reduces chronic graft inflammation and tubular atrophy. Transplantation. 2010 Sep 27;90(6):612-21. doi: 10.1097/tp.0b013e3181d72117.
- Koo DD, Welsh KI, Roake JA, Morris PJ, Fuggle SV. Ischemia/reperfusion injury in human kidney transplantation: an immunohistochemical analysis of changes after reperfusion. Am J Pathol. 1998 Aug;153(2):557-66. doi: 10.1016/S0002-9440(10)65598-8.
- Levine MA, Rasmussen A, Lee D, Rim C, Farokhi K, Luke PP, Sener A. Prospective assessment of the impact of intraoperative diuretics in kidney transplant recipient surgery. Can J Surg. 2024 Apr 4;67(2):E158-E164. doi: 10.1503/cjs.006422. Print 2024 Jan-Feb.
- Yarlagadda SG, Coca SG, Formica RN Jr, Poggio ED, Parikh CR. Association between delayed graft function and allograft and patient survival: a systematic review and meta-analysis. Nephrol Dial Transplant. 2009 Mar;24(3):1039-47. doi: 10.1093/ndt/gfn667. Epub 2008 Dec 22.
- Levine MA, Chin JL, Rasmussen A, Sener A, Luke PP. The history of renal transplantation in Canada: A urologic perspective. Can Urol Assoc J. 2020 Dec;14(12):372-379. doi: 10.5489/cuaj.6744.
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Estimado)
1 de setembro de 2026
Conclusão Primária (Estimado)
1 de agosto de 2028
Conclusão do estudo (Estimado)
1 de dezembro de 2028
Datas de inscrição no estudo
Enviado pela primeira vez
14 de julho de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
20 de julho de 2026
Primeira postagem (Real)
24 de julho de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
18 de setembro de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
15 de setembro de 2026
Última verificação
1 de setembro de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Doenças Vasculares
- Doenças cardiovasculares
- Complicações pós-operatórias
- Processos Patológicos
- Condições Patológicas, Sinais e Sintomas
- Função de Enxerto Retardada
- Lesão de Reperfusão
- Compostos de enxofre
- Produtos químicos orgânicos
- Carboidratos
- Amidas
- Compostos de anilina
- Aminas
- Álcoons
- Sulfonamidas
- Sulfanilamidas
- Sulfonas
- Álcoois de açúcar
- Furosemida
- Manitol
Outros números de identificação do estudo
- 16816
- AHSC AFP Innovation Fund (Número de outro subsídio/financiamento: Academic Medical Organization of Southwestern Ontario)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Descrição do plano IPD
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.
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .