Recruiting

Observational Study

Sponsor:

Université de Sherbrooke

Code:

NCT03786991

Conditions

Organ Donation

Liver Transplantation

Kidney Transplantation

Graft Dysfunction

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

No intervention

Study Details

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 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

Organ Donation

Liver Transplantation

Kidney Transplantation

Graft Dysfunction

Study ID

NCT03786991

Start date

Dec 16, 2018

Status verified date

May, 2024

Completion date

Dec 1, 2025

Anticipated

Primary completion date

Mar 24, 2025

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

105 participants

Anticipated

Interventions and Outcome Measures

Arms

Organ donors

Organ donors after neurologic death (NDD) of 18 years old and older for whom consent to organ donation has been obtained.

Liver and kidney Recipients

Liver and kidney recipients of 18 years old and older.

Interventions

No intervention

No intervention

Primary outcome measure

  • Kidney delayed graft function [ Time Frame: 7-days post-transplantation ]

Central Contacts and Locations

Central contacts

Locations

Hôpital Maisonneuve-Rosemont

Recruiting

Montréal, Quebec, Canada, H1T 2M4

Centre Hospitalier Universitaire de Montréal

Recruiting

Montréal, Quebec, Canada, H2X 3E4

Centre Hospitalier Universitaire de Québec- Université Laval

Recruiting

Quebec city, Quebec, Canada, G1V 4G2

CIUSSS de l'Estrie-CHUS

Recruiting

Sherbrooke, Quebec, Canada, J1H 5N4

Contacts

More Information

Sponsor

Université de Sherbrooke

Last update posted

Apr 2, 2025

Last verified

May, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Université de Sherbrooke on 2025-04-02.