Actively Recruiting

Age: 18Years - 80Years
All Genders
NCT03786991

EPI-STORM: Cytokine Storm in Organ Donors

Led by Université de Sherbrooke · Updated on 2025-04-02

105

Participants Needed

4

Research Sites

363 weeks

Total Duration

On this page

Sponsors

U

Université de Sherbrooke

Lead Sponsor

C

Centre de recherche du CHUS

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

EPI-STORM: Cytokine Storm in Organ Donors

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient admitted to the intensive care unit with a serious neurologic lesion
  • Glasgow Coma Scale score �3C= 4
  • Absence of sedation for the last 6 hours
  • Age �3E= 18 years old
  • Organ donor after neurologic death declaration as determined by the attending physician
  • Consent to organ donation obtained
Not Eligible

You will not qualify if you...

  • S. aureus bacteremia
  • Active neoplasia
  • Receiving immunosuppressive therapy (including steroids) for more than 3 months
  • For potential liver donors: Hepatic insufficiency defined as i) INR > 1.5, ii) hepatic encephalopathy, iii) AST or ALT more than 2 times normal value
  • For potential kidney donors: Polycystic kidney disease
  • Chronic renal failure with eGFR less than 60 ml/min

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 4 locations

1

Hôpital Maisonneuve-Rosemont

Montreal, Quebec, Canada, H1T 2M4

Actively Recruiting

2

Centre Hospitalier Universitaire de Montréal

Montreal, Quebec, Canada, H2X 3E4

Actively Recruiting

3

Centre Hospitalier Universitaire de Québec- Université Laval

Québec, Quebec, Canada, G1V 4G2

Actively Recruiting

4

CIUSSS de l'Estrie-CHUS

Sherbrooke, Quebec, Canada, J1H 5N4

Actively Recruiting

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Research Team

M

Marie-Hélène Masse, RRT, M.Sc.

CONTACT

D

Daphnée Lamarche, PhD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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