EPI-STORM: Cytokine Storm in Organ Donors

Launched by UNIVERSITÉ DE SHERBROOKE · Dec 19, 2018

Keywords

ClinConnect Summary

The EPI-STORM trial is studying how the immune system reacts in organ donors who have suffered brain death, particularly focusing on kidneys and livers. When someone experiences neurological death, their body can go into a state of inflammation that may affect the quality of the organs available for transplantation. This trial aims to understand these inflammatory processes better, which could lead to improved treatments for donors and ultimately enhance the success of organ transplants for patients in need.

To participate in this study, donors must be adults aged 18 or older who have been declared brain dead and have consented to organ donation. The study will not include individuals with certain infections, cancers, or those who have been on immunosuppressive therapy for an extended period. Participants will be closely monitored in the intensive care unit to gather important information about their health and the condition of the organs for transplantation. This research is crucial because it aims to increase the number of viable organs available and improve the survival rates of patients receiving these transplants.

Gender

ALL

Eligibility 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