Effects of cyclosporine A pretreatment of deceased organ donors on kidney graft function (Cis-A-rein): study protocol for a randomized controlled trial
Abstract Background Renal transplantation represents the treatment of choice of end-stage kidney disease. Delayed graft function (DGF) remains the most frequent complication after this procedure, reaching more than 30%. Its prevention is essential as it impedes early- and long-term prognosis of tran...
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| Format: | Article |
| Language: | English |
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BMC
2018-04-01
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| Series: | Trials |
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| Online Access: | http://link.springer.com/article/10.1186/s13063-018-2597-4 |
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| author | Jean-Christophe Orban Eric Fontaine Elisabeth Cassuto Karine Baumstarck Marc Leone Jean-Michel Constantin Carole Ichai for the AzuRéa network |
| author_facet | Jean-Christophe Orban Eric Fontaine Elisabeth Cassuto Karine Baumstarck Marc Leone Jean-Michel Constantin Carole Ichai for the AzuRéa network |
| author_sort | Jean-Christophe Orban |
| collection | DOAJ |
| description | Abstract Background Renal transplantation represents the treatment of choice of end-stage kidney disease. Delayed graft function (DGF) remains the most frequent complication after this procedure, reaching more than 30%. Its prevention is essential as it impedes early- and long-term prognosis of transplantation. Numerous pharmacological interventions aiming to prevent ischemia-reperfusion injuries failed to reduce the rate of DGF. We hypothesize that cyclosporine as an early preconditioning procedure in donors would be associated with decreased DGF. Methods The Cis-A-rein study is an investigator-initiated, prospective, multicenter, double-blind, randomized, controlled study performed to assess the effects of a donor preconditioning with cyclosporine A on kidney grafts function in transplanted patients. After randomization, a brain dead donor will receive 2.5 mg kg−1 of cyclosporine A or the same volume of 5% glucose solution. The primary objective is to compare the rate of DGF, defined as the need for at least one dialysis session within the 7 days following transplantation, between both groups. The secondary objectives include rate of slow graft function, mild and severe DGF, urine output and serum creatinine during the first week after transplantation, rate of primary graft dysfunction, renal function and mortality at 1 year. The sample size (n = 648) was determined to obtain 80% power to detect a 10% difference for rate of DGF at day 7 between the two groups (30% of the patients in the placebo group and 20% of the patients in the intervention group). Discussion Delayed graft function is a major issue after renal transplantation, impeding long-term prognosis. Cyclosporine A pretreatment in deceased donors could improve the outcome of patients after renal transplantation. Trial registration ClinicalTrials.gov, ID: NCT02907554 Registered on 20 September 2016. |
| first_indexed | 2024-04-12T15:56:15Z |
| format | Article |
| id | doaj.art-93909cae26584355883a97e0ca960ec7 |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-04-12T15:56:15Z |
| publishDate | 2018-04-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-93909cae26584355883a97e0ca960ec72022-12-22T03:26:21ZengBMCTrials1745-62152018-04-011911610.1186/s13063-018-2597-4Effects of cyclosporine A pretreatment of deceased organ donors on kidney graft function (Cis-A-rein): study protocol for a randomized controlled trialJean-Christophe Orban0Eric Fontaine1Elisabeth Cassuto2Karine Baumstarck3Marc Leone4Jean-Michel Constantin5Carole Ichai6for the AzuRéa networkUniversité Côte d’Azur, Service de Réanimation Polyvalente, Hôpital Pasteur 2Unité de Nutrition artificielle, CHU de GrenobleTransplantation Rénale, Hôpital Pasteur 2, CHU NiceDélégation à la Recherche Clinique et à l’Innovation, Assistance Publique Hôpitaux de MarseilleService Anesthésie et Réanimation, Hôpital Nord, Aix Marseille Université, Assistance Publique Hôpitaux de MarseilleDépartement de Médecine Péri-opératoire, CHU de Clermont-FerrandUniversité Côte d’Azur, Service de Réanimation Polyvalente, Hôpital Pasteur 2Abstract Background Renal transplantation represents the treatment of choice of end-stage kidney disease. Delayed graft function (DGF) remains the most frequent complication after this procedure, reaching more than 30%. Its prevention is essential as it impedes early- and long-term prognosis of transplantation. Numerous pharmacological interventions aiming to prevent ischemia-reperfusion injuries failed to reduce the rate of DGF. We hypothesize that cyclosporine as an early preconditioning procedure in donors would be associated with decreased DGF. Methods The Cis-A-rein study is an investigator-initiated, prospective, multicenter, double-blind, randomized, controlled study performed to assess the effects of a donor preconditioning with cyclosporine A on kidney grafts function in transplanted patients. After randomization, a brain dead donor will receive 2.5 mg kg−1 of cyclosporine A or the same volume of 5% glucose solution. The primary objective is to compare the rate of DGF, defined as the need for at least one dialysis session within the 7 days following transplantation, between both groups. The secondary objectives include rate of slow graft function, mild and severe DGF, urine output and serum creatinine during the first week after transplantation, rate of primary graft dysfunction, renal function and mortality at 1 year. The sample size (n = 648) was determined to obtain 80% power to detect a 10% difference for rate of DGF at day 7 between the two groups (30% of the patients in the placebo group and 20% of the patients in the intervention group). Discussion Delayed graft function is a major issue after renal transplantation, impeding long-term prognosis. Cyclosporine A pretreatment in deceased donors could improve the outcome of patients after renal transplantation. Trial registration ClinicalTrials.gov, ID: NCT02907554 Registered on 20 September 2016.http://link.springer.com/article/10.1186/s13063-018-2597-4Cyclosporine APreconditioningTransplantationKidneyDelayed graft function |
| spellingShingle | Jean-Christophe Orban Eric Fontaine Elisabeth Cassuto Karine Baumstarck Marc Leone Jean-Michel Constantin Carole Ichai for the AzuRéa network Effects of cyclosporine A pretreatment of deceased organ donors on kidney graft function (Cis-A-rein): study protocol for a randomized controlled trial Trials Cyclosporine A Preconditioning Transplantation Kidney Delayed graft function |
| title | Effects of cyclosporine A pretreatment of deceased organ donors on kidney graft function (Cis-A-rein): study protocol for a randomized controlled trial |
| title_full | Effects of cyclosporine A pretreatment of deceased organ donors on kidney graft function (Cis-A-rein): study protocol for a randomized controlled trial |
| title_fullStr | Effects of cyclosporine A pretreatment of deceased organ donors on kidney graft function (Cis-A-rein): study protocol for a randomized controlled trial |
| title_full_unstemmed | Effects of cyclosporine A pretreatment of deceased organ donors on kidney graft function (Cis-A-rein): study protocol for a randomized controlled trial |
| title_short | Effects of cyclosporine A pretreatment of deceased organ donors on kidney graft function (Cis-A-rein): study protocol for a randomized controlled trial |
| title_sort | effects of cyclosporine a pretreatment of deceased organ donors on kidney graft function cis a rein study protocol for a randomized controlled trial |
| topic | Cyclosporine A Preconditioning Transplantation Kidney Delayed graft function |
| url | http://link.springer.com/article/10.1186/s13063-018-2597-4 |
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