Status:
RECRUITING
EPI-STORM: Cytokine Storm in Organ Donors
Lead Sponsor:
Université de Sherbrooke
Collaborating Sponsors:
Centre de recherche du CHUS
Conditions:
Organ Donation
Liver Transplantation
Eligibility:
All Genders
18-80 years
Brief 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 avai...
Detailed Description
Severe neurological injuries, such as those observed in neurologically deceased donors, trigger a pro-inflammatory state that activates the immune system, increases vascular permeability, and recruits...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
December 16 2018
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
105 Patients enrolled
Trial Details
Trial ID
NCT03786991
Start Date
December 16 2018
End Date
December 1 2025
Last Update
April 2 2025
Active Locations (4)
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1
Hôpital Maisonneuve-Rosemont
Montreal, Quebec, Canada, H1T 2M4
2
Centre Hospitalier Universitaire de Montréal
Montreal, Quebec, Canada, H2X 3E4
3
Centre Hospitalier Universitaire de Québec- Université Laval
Québec, Quebec, Canada, G1V 4G2
4
CIUSSS de l'Estrie-CHUS
Sherbrooke, Quebec, Canada, J1H 5N4