EPI-STORM: Cytokine Storm in Organ Donors
EPI-STORM Cytokine Storm in Organ Donors: A Translational Study Linking Donor Epigenetic to Transplantation Success in Recipient
Université de Sherbrooke
105 participants
Dec 16, 2018
OBSERVATIONAL
Conditions
Summary
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
Eligibility
Inclusion Criteria7
- Phase 1 of the study:
- 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
- Organ donor after neurologic death (DND) declaration as determined by the attending physician
- Consent to organ donation obtained
Exclusion Criteria9
- 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:
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Interventions
No intervention
Locations(4)
View Full Details on ClinicalTrials.gov
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NCT03786991