Understanding cytokine storms in organ donors
EPI-STORM Cytokine Storm in Organ Donors: A Translational Study Linking Donor Epigenetic to Transplantation Success in Recipient
This study looks at how inflammation in organ donors after brain death affects the success of kidney and liver transplants for the people who receive them.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 105 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Université de Sherbrooke Academic / other |
| Locations | 4 sites (Montreal, Quebec and 3 other locations) |
| Trial ID | NCT03786991 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the pro-inflammatory status of neurologically deceased organ donors by examining circulating cytokines and miRNA biomarkers. It focuses on the inflammatory processes that occur in donors following neurological death, which may negatively impact graft function in recipients. By analyzing blood specimens from organ donors, the study seeks to establish a connection between the inflammatory state of the donor and the outcomes of kidney and liver transplants. The findings could inform future trials on personalized immunosuppressive therapies for improving transplant success.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals who are neurologically deceased and have consented to organ donation.
Not a fit: Patients with active neoplasia or those receiving long-term immunosuppressive therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved graft function and survival rates for kidney and liver transplant recipients.
How similar studies have performed: While the study explores a novel approach to understanding donor inflammatory states, similar studies have indicated that targeting inflammatory markers could improve transplant outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Montreal, Quebec and 3 other locations
- Hôpital Maisonneuve-Rosemont — Montreal, Quebec, Canada (Recruiting)
- Centre Hospitalier Universitaire de Montréal — Montreal, Quebec, Canada (Recruiting)
- Centre Hospitalier Universitaire de Québec- Université Laval — Québec, Quebec, Canada (Recruiting)
- CIUSSS de l'Estrie-CHUS — Sherbrooke, Quebec, Canada (Recruiting)
Study contacts
- Principal investigator: Dr Frédérick D'Aragon, MD FRCPC MSc — Université de Sherbrooke
- Study coordinator: Marie-Hélène Masse, RRT, M.Sc.
- Email: marie-helene.masse3@usherbrooke.ca
- Phone: 819-346-1110
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.