Kidney Transplantation Clinical Trial
— EPI-STORMOfficial title:
EPI-STORM Cytokine Storm in Organ Donors: A Translational Study Linking Donor Epigenetic to Transplantation Success in Recipient
Kidney and liver transplantation are the treatment of choice and are often the last therapeutic option offered to patients with chronic renal and liver failure. More than 70% of kidneys and liver available for transplantation are obtained from donors following neurological death. Unfortunately, compared to living donation, transplant function, graft survival, and recipient survival are consistently inferior with kidneys and liver from neurologically deceased donors. This difference lies with the exacerbated pro-inflammatory state characteristic of deceased donors. Indeed, when neurologic death occurs, the immune system releases substances in the blood that could harm organs and particularly the liver and the kidneys. We believe that achieving a better understanding of the inflammatory processes of organ donors could be greatly informative to design future randomized controlled trial assessing the effect of personalized immunosuppressive therapy on organ donors to ultimately improve the care provided to donors so as to increase the number of organs available for transplantation and enhancing the survival of received grafts
Status | Recruiting |
Enrollment | 105 |
Est. completion date | December 1, 2025 |
Est. primary completion date | December 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Phase 1 of the study: Inclusion Criteria: - Patient admitted to the intensive care unit with a serious neurologic lesion - Glasgow Coma Scale score = 4 - Absence of sedation for the last 6 hours - Age = 18 years old Exclusion Criteria: - S. aureus bacteremia - Active neoplasia - Receiving immunosuppressive therapy (including steroids) for > 3 months Specific to potential liver donors: - Hepatic insufficiency defined as i) INR > 1.5, ii) hepatic encephalopathy, iii) AST, ALT > 2 times normal value Specific to potential kidney donors: - Polycystic kidney disease - Chronic renal failure (i.e., eGFR < 60 ml/min) Phase 2 of the study: Inclusion Criteria: - Organ donor after neurologic death (DND) declaration as determined by the attending physician - Consent to organ donation obtained |
Country | Name | City | State |
---|---|---|---|
Canada | Centre Hospitalier Universitaire de Montréal | Montréal | Quebec |
Canada | Hôpital Maisonneuve-Rosemont | Montréal | Quebec |
Canada | Centre Hospitalier Universitaire de Québec- Université Laval | Quebec city | Quebec |
Canada | CIUSSS de l'Estrie-CHUS | Sherbrooke | Quebec |
Lead Sponsor | Collaborator |
---|---|
Université de Sherbrooke | Centre de recherche du CHUS |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Kidney delayed graft function | Requirement for renal replacement therapy within the first 7 days following transplantation or decrease of < 10% of creatinine after 3 days after transplantation, or creatinine > 250 µmol/l at day 5 with evidence of delayed graft function by renal scintigraphy | 7-days post-transplantation | |
Secondary | Liver early graft dysfunction | Presence of one of the following three criteria: (i) peak AST or ALT > 2000 U/L during the first 7 days, (ii) bilirubin = 10 mg/dL on day 7 postoperatively, or (iii) INR = 1.6 on day 7 postoperatively | 7-days post-transplantation | |
Secondary | Quantification of circulatory cytokines | Quantification of IL-1ß, IL-2, IL-4, IL-6, IL-10, IL-12 (p70), IL-13, IFN-?, and TNF-a by Luminex (Multiplex human cytokine panel, Millipore) | From ICU admission up to organ recovery (5 timepoints(1:ICU admission; 2: consent to organ donation, 3: 4 to 8 hours after sample #2, 4: 24 hours after sample #2; 5: prior to transfer from ICU to operating room); 25 donors). | |
Secondary | Identification of inflammatory-related miRNA targets using micro-transcriptome analyses | Sequencing on an Illumina NovaSeq 6000 sequencing platform | From ICU admission up to organ recovery (5 timepoints (1:ICU admission; 2: consent to organ donation, 3: 4 to 8 hours after sample #2, 4: 24 hours after sample #2; 5: prior to transfer from ICU to operating room) ;25 donors). | |
Secondary | Validation of inflammatory-related miRNA targets using targeted quantification | Quantification by RT-qPCR using TaqMan Advanced miRNA Assays | From ICU admission up to organ recovery (5 timepoints(1:ICU admission; 2: consent to organ donation, 3: 4 to 8 hours after sample #2, 4: 24 hours after sample #2; 5: prior to transfer from ICU to operating room); 105 donors). | |
Secondary | Validation of circulatory cytokines | Quantification of identified cytokines (in the 25 donors cohort) by Luminex (Multiplex, Millipore) | From ICU admission up to organ recovery (5 timepoints (1:ICU admission; 2: consent to organ donation, 3: 4 to 8 hours after sample #2, 4: 24 hours after sample #2; 5: prior to transfer from ICU to operating room); 105 donors). |
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