The Impact of Intraoperative Diuretic Use on Delayed Graft Function Following Deceased Donor Renal Transplantation
A Pilot Randomized, Surgeon-blinded, Trial of Intraoperative Furosemide Versus Mannitol Among Deceased Donor Kidney Transplant Recipients
Studienübersicht
Status
Status
Bedingungen
Bedingungen
Intervention / Behandlung
Intervention / Behandlung
Detaillierte Beschreibung
Studientyp
Studientyp
Einschreibung (Geschätzt)
Einschreibung
Phase
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
Studienkontakt
- Name: Cadence Research Manager, BSc, MSc
- Telefonnummer: 34769 (519) 685-8500
- E-Mail: Cadence.Baker@lhsc.on.ca
Studienorte
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Ontario
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London, Ontario, Kanada, N6A 5A5
- Rekrutierung
- University Hospital - London Health Sciences Centre
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Kontakt:
- Cadence Baker, BSc, MSc
- Telefonnummer: 34769 5196858500
- E-Mail: Cadence.Baker@lhsc.on.ca
-
Hauptermittler:
- Dr. Alp Sener, MD, PhD
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London, Ontario, Kanada, n6a 5a5
- Noch keine Rekrutierung
- London Health Sciences Centre
-
Kontakt:
- Cadence Research Manager, BSc, MSc
- Telefonnummer: 34769 +15196858500
- E-Mail: Cadence.Baker@lhsc.on.ca
-
-
Teilnahmekriterien
Zulassungskriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Doppelt
Anzahl der Arme
Waffen und Interventionen
Teilnehmergruppe / ArmTeilnehmergruppe / Arm |
Intervention / BehandlungIntervention / Behandlung |
|---|---|
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Aktiver Komparator: 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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Aktiver Komparator: 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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Was misst die Studie?
Primäre Ergebnismessungen
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Recruitment rate
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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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Sekundäre Ergebnismessungen
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Early graft function
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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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Mitarbeiter und Ermittler
Sponsor
Sponsor
Publikationen und hilfreiche Links
Allgemeine Veröffentlichungen
- 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.
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Studienbeginn
Primärer Abschluss (Geschätzt)
Primärer Abschluss
Studienabschluss (Geschätzt)
Studienabschluss
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Zuerst gepostet
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes Update gepostet
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Gefäßerkrankungen
- Herz-Kreislauf-Erkrankungen
- Postoperative Komplikationen
- Pathologische Prozesse
- Pathologische Zustände, Anzeichen und Symptome
- Verzögerte Graft-Funktion
- Reperfusionsverletzung
- Schwefelverbindungen
- Organische Chemikalien
- Kohlenhydrate
- Amides
- Anilinverbindungen
- Amine
- Alkohole
- Sulfonamide
- Sulfanilamide
- Sulfone
- Zuckeralkohole
- Furosemid
- Mannit
Andere Studien-ID-Nummern
Andere Studien-ID-Nummern
- 16816
- AHSC AFP Innovation Fund (Andere Zuschuss-/Finanzierungsnummer: Academic Medical Organization of Southwestern Ontario)
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