The Impact of Intraoperative Diuretic Use on Delayed Graft Function Following Deceased Donor Renal Transplantation
2026年9月15日 更新者: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.
調査の概要
詳細な説明
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.
研究の種類
介入
入学 (推定)
160
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前:Cadence Research Manager, BSc, MSc
- 電話番号:34769 (519) 685-8500
- メール:Cadence.Baker@lhsc.on.ca
研究場所
-
-
Ontario
-
London、Ontario、カナダ、N6A 5A5
- 募集
- University Hospital - London Health Sciences Centre
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コンタクト:
- Cadence Baker, BSc, MSc
- 電話番号:34769 5196858500
- メール:Cadence.Baker@lhsc.on.ca
-
主任研究者:
- Dr. Alp Sener, MD, PhD
-
London、Ontario、カナダ、n6a 5a5
- まだ募集していません
- London Health Sciences Centre
-
コンタクト:
- Cadence Research Manager, BSc, MSc
- 電話番号:34769 +15196858500
- メール:Cadence.Baker@lhsc.on.ca
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:処理
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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アクティブコンパレータ:Furosemide
In the Furosemide arm, 80 mg IV will be administered at 10-15 minutes prior to reperfusion of the transplanted kidney.
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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.
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アクティブコンパレータ: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.
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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.
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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Recruitment rate
時間枠:From enrollment to the end of the study (1 year)
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Proportion of eligible patients who were approached and consented to enroll.
Recruitment rate = number enrolled ÷ number of eligible patients screened.
Reported as a percentage.
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From enrollment to the end of the study (1 year)
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Consent Rate
時間枠:From enrollment to the end of the study (1 year).
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Consent rate = number who consented ÷ number approached.
Reported as a percentage.
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From enrollment to the end of the study (1 year).
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Protocol Adherence
時間枠:From enrollment to end of study (1 year)
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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.
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From enrollment to end of study (1 year)
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Data Completeness
時間枠:From enrollment to end of study (1 year)
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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.
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From enrollment to end of study (1 year)
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Delayed Graft Function (DGF)
時間枠:From the administration of study drug until the end of post-op day 7.
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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).
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From the administration of study drug until the end of post-op day 7.
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Early graft function
時間枠:From the time of enrollment up until post op day 7.
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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.
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From the time of enrollment up until post op day 7.
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Postoperative dialysis requirement
時間枠:Post-op day 0 until the end of enrollment (1 year)
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2. To compare postoperative dialysis requirements, including number and duration of dialysis sessions.
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Post-op day 0 until the end of enrollment (1 year)
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Post-operative Outcomes
時間枠:Post-op day 0 until the end of post-op day 30
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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
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Post-op day 0 until the end of post-op day 30
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Survival
時間枠:Post-op day 0 up until post-op day 365 (1 year post enrollment)
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4. To compare length of hospital stay and 1-year graft and patient survival between groups.
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Post-op day 0 up until post-op day 365 (1 year post enrollment)
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- 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.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年9月1日
一次修了 (推定)
2028年8月1日
研究の完了 (推定)
2028年12月1日
試験登録日
最初に提出
2026年7月14日
QC基準を満たした最初の提出物
2026年7月20日
最初の投稿 (実際)
2026年7月24日
学習記録の更新
投稿された最後の更新 (実際)
2026年9月18日
QC基準を満たした最後の更新が送信されました
2026年9月15日
最終確認日
2026年9月1日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- 16816
- AHSC AFP Innovation Fund (その他の助成金/資金番号:Academic Medical Organization of Southwestern Ontario)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
IPD プランの説明
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.
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
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