Impact of Perioperative Organ Resuscitation of Brain-dead Deceased Organ Donor on Kidney Graft Function in the Recipient (OPTI-PMO 2)

Brain-dead patients are the primary source of grafts for those awaiting organ transplantation. Recommendations exist for the management of these potential donors, based on the concept of organ resuscitation, according to which targeted resuscitation would improve graft quality and quantity.

Graft performance thus depends on fixed factors (donor/recipient age, medical history, etc.) but also potentially modifiable factors.

Through this study, the investigators aim to identify potentially modifiable factors in our donor care (in intensive care and the operating room) that may influence graft function in the recipient. For simplicity, the investigators will focus on kidney grafts. The aim is to improve the effectiveness of the transplant and reduce waiting times.

Study Overview

• Status: Recruiting
• Conditions: Kidney Graft

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Charlotte POUSSARDIN, MD; Phone Number: 33.3.69.55.16.21; Email: charlotte.poussardin@chru-strasbourg.fr

Study Locations

• France
  • Strasbourg, France, 67091
    • Recruiting
    • Service d'Anesthésie, Réanimation et Médecine Périopératoire - CHU de Strasbourg - France
    • Sub-Investigator: Benjamin Lebas, MD
    • Contact: Charlotte POUSSARDIN, MD; Phone Number: 33.3.69.55.16.21; Email: charlotte.poussardin@chru-strasbourg.fr
    • Principal Investigator: Charlotte POUSSARDIN, MD
    • Sub-Investigator: Quentin GISSELBRECHT, MD
    • Sub-Investigator: Cédric Fuchs, MD
    • Sub-Investigator: Julien Godet, Statician

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Subject adulte

Description

Inclusion Criteria:

The inclusion criteria for organ donor patients are as follows:

• Adult patient
• Brain dead
• Hospitalized in surgical intensive care at Strasbourg University Hospital (NHC cardiovascular intensive care unit, NHC multi-purpose intensive care unit, Hautepierre surgical intensive care unit) from January 1, 2018 to December 31, 2023
• Having undergone multi-organ transplantation
• At least one of the donor kidneys has been transplanted to a patient at Strasbourg University Hospital
• Absence of written objection in the medical file of the subject (and/or their legal representative, if applicable) to the reuse of their data for scientific research purposes.

The inclusion criteria for kidney transplant recipients are as follows:

• Adult patient
• Recipient of a kidney transplant from an organ donor who meets the inclusion criteria for donor patients mentioned above
• Patient who has undergone surgery and is hospitalized post-operatively at Strasbourg University Hospital
• Patient monitored by the Strasbourg University Hospital transplant team
• Absence of written objection in the subject's medical file (and/or their legal representative, if applicable) to the reuse of their data for scientific research purposes.

Exclusion Criteria:

• Subject (and/or their legal representative, if applicable) who has expressed their opposition to the reuse of their data for scientific research purposes
• Brain-dead patient who has not undergone organ retrieval
• Brain-dead patient whose kidney has not been allocated to a recipient in Strasbourg
• Patient transferred to the Strasbourg University Hospital's intensive care unit from another hospital in a state of already diagnosed brain death solely for organ retrieval
• Kidney transplant patient with a graft from a living donor
• Kidney transplant patient with a graft from a deceased donor who is not brain-dead
• Kidney transplant patient with a graft from a deceased donor who is brain-dead and hospitalized in a hospital other than Strasbourg

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ratio of creatinine decrease	Ratio of creatinine decrease on days 1 and 2 in kidney transplant recipients (formula: CRR2% = ((Cr1-Cr2)*100)/Cr1) or the need for dialysis before day 2.	Days 1 and 2 in kidney transplant recipients

Collaborators and Investigators

• Sponsor: University Hospital, Strasbourg, France

Study record dates

Study Major Dates

• Study Start (Actual): April 10, 2024
• Primary Completion (Estimated): December 10, 2025
• Study Completion (Estimated): December 10, 2025

Study Registration Dates

• First Submitted: March 26, 2025
• First Submitted That Met QC Criteria: March 26, 2025
• First Posted (Actual): April 2, 2025

Study Record Updates

• Last Update Posted (Actual): April 2, 2025
• Last Update Submitted That Met QC Criteria: March 26, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Grafts; Organ transplantation; Kidney Graft
• Additional Relevant MeSH Terms: Neurologic Manifestations; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pathologic Processes; Neurobehavioral Manifestations; Death; Consciousness Disorders; Unconsciousness; Coma; Brain Death
• Other Study ID Numbers: 9245 (Fred Hutch/University of Washington Cancer Consortium)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No