Mannitol Use During Cadaveric Kidney Transplantation
Summary
We propose a placebo controlled randomized study on the use of mannitol as an agent to protect against delayed graft function, during the surgical procedure of kidney transplantation from a cadaver. Patients undergoing kidney transplantation for the treatment of end stage kidney disease will be randomized in a ratio of 1:1 to receive either intravenous mannitol or saline during their procedure, administered prior to renal artery clamp release and reperfusion of the kidney. Changes in renal function following surgery and the incidence and duration of delayed graft function (DGF) will be monitored using calculated glomerular filtration rate (eGFR) and the need for dialysis performed post-operatively, as part of routine standard of care. Additionally biological samples will be collected and analyzed for use of a non invasive biomarker for delayed graft function.
Timeline
- Start
- 2022-02
- Primary completion
- 2022-02
- Completion
- 2022-02
Publications
- Background Lugo-Baruqui JA, Ayyathurai R, Sriram A, Pragatheeshwar KD. Use of Mannitol for Ischemia Reperfusion Injury in Kidney Transplant and Partial Nephrectomies-Review of Literature. Curr Urol Rep. 2019 Jan 26;20(1):6. doi: 10.1007/s11934-019-0868-6.
- Background Gagandeep S, Matsuoka L, Mateo R, Cho YW, Genyk Y, Sher L, Cicciarelli J, Aswad S, Jabbour N, Selby R. Expanding the donor kidney pool: utility of renal allografts procured in a setting of uncontrolled cardiac death. Am J Transplant. 2006 Jul;6(7):1682-8. doi: 10.1111/j.1600-6143.2006.01386.x.
- Background Foroutan F, Friesen EL, Clark KE, Motaghi S, Zyla R, Lee Y, Kamran R, Ali E, De Snoo M, Orchanian-Cheff A, Ribic C, Treleaven DJ, Guyatt G, Meade MO. Risk Factors for 1-Year Graft Loss After Kidney Transplantation: Systematic Review and Meta-Analysis. Clin J Am Soc Nephrol. 2019 Nov 7;14(11):1642-1650. doi: 10.2215/CJN.05560519. Epub 2019 Sep 20.
- Background de Sandes-Freitas TV, Felipe CR, Aguiar WF, Cristelli MP, Tedesco-Silva H, Medina-Pestana JO. Prolonged Delayed Graft Function Is Associated with Inferior Patient and Kidney Allograft Survivals. PLoS One. 2015 Dec 17;10(12):e0144188. doi: 10.1371/journal.pone.0144188. eCollection 2015.
- Background Dawidson IJ, Sandor ZF, Coorpender L, Palmer B, Peters P, Lu C, Sagalowsky A, Risser R, Willms C. Intraoperative albumin administration affects the outcome of cadaver renal transplantation. Transplantation. 1992 Apr;53(4):774-82. doi: 10.1097/00007890-199204000-00014.
- Background Willms CD, Dawidson IJ, Dickerman R, Drake D, Sandor ZF, Trevino G. Intraoperative blood volume expansion induces primary function after renal transplantation: a study of 96 paired cadaver kidneys. Transplant Proc. 1991 Feb;23(1 Pt 2):1338-9. No abstract available.
- Background Lewis SR, Pritchard MW, Evans DJ, Butler AR, Alderson P, Smith AF, Roberts I. Colloids versus crystalloids for fluid resuscitation in critically ill people. Cochrane Database Syst Rev. 2018 Aug 3;8(8):CD000567. doi: 10.1002/14651858.CD000567.pub7.
- Background Weimar W, Geerlings W, Bijnen AB, Obertop H, van Urk H, Lameijer LD, Wolff ED, Jeekel J. A controlled study on the effect of mannitol on immediate renal function after cadaver donor kidney transplantation. Transplantation. 1983 Jan;35(1):99-101. No abstract available.
- Background 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.
- Background von Moos S, Akalin E, Mas V, Mueller TF. Assessment of Organ Quality in Kidney Transplantation by Molecular Analysis and Why It May Not Have Been Achieved, Yet. Front Immunol. 2020 May 12;11:833. doi: 10.3389/fimmu.2020.00833. eCollection 2020.
- Background Reiterer C, Hu K, Sljivic S, Falkner von Sonnenburg M, Fleischmann E, Kainz A, Kabon B. Mannitol and renal graft injury in patients undergoing deceased donor renal transplantation - a randomized controlled clinical trial. BMC Nephrol. 2020 Jul 28;21(1):307. doi: 10.1186/s12882-020-01961-z.
- Background Gremmels H, de Jong OG, Toorop RJ, Michielsen L, van Zuilen AD, Vlassov AV, Verhaar MC, van Balkom BWM. The Small RNA Repertoire of Small Extracellular Vesicles Isolated From Donor Kidney Preservation Fluid Provides a Source for Biomarker Discovery for Organ Quality and Posttransplantation Graft Function. Transplant Direct. 2019 Aug 12;5(9):e484. doi: 10.1097/TXD.0000000000000929. eCollection 2019 Sep.
- Background Siew ED, Ware LB, Ikizler TA. Biological markers of acute kidney injury. J Am Soc Nephrol. 2011 May;22(5):810-20. doi: 10.1681/ASN.2010080796. Epub 2011 Apr 14.
- Background Tataruch-Weinert D, Musante L, Kretz O, Holthofer H. Urinary extracellular vesicles for RNA extraction: optimization of a protocol devoid of prokaryote contamination. J Extracell Vesicles. 2016 Jun 24;5:30281. doi: 10.3402/jev.v5.30281. eCollection 2016.
- Background Feng Y, Lv LL, Wu WJ, Li ZL, Chen J, Ni HF, Zhou LT, Tang TT, Wang FM, Wang B, Chen PS, Crowley SD, Liu BC. Urinary Exosomes and Exosomal CCL2 mRNA as Biomarkers of Active Histologic Injury in IgA Nephropathy. Am J Pathol. 2018 Nov;188(11):2542-2552. doi: 10.1016/j.ajpath.2018.07.017. Epub 2018 Aug 22.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Mannitol | Diagnostic / imaging agent | 0.5 g/kg | Intravenous |
Indications
No indication recorded.