Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06907758

Impact of Perioperative Organ Resuscitation of Brain-dead Deceased Organ Donor on Kidney Graft Function in the Recipient

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Kidney Graft

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Service d'Anesthésie, Réanimation et Médecine Périopératoire - CHU de Strasbourg - France

Strasbourg, 67091, France

Location status: Recruiting

Location contact

Benjamin Lebas, MD

SUB_INVESTIGATOR

Charlotte POUSSARDIN, MD

CONTACT

[email protected]

33.3.69.55.16.21

Charlotte POUSSARDIN, MD

PRINCIPAL_INVESTIGATOR

Cédric Fuchs, MD

SUB_INVESTIGATOR

Julien Godet, Statician

SUB_INVESTIGATOR

Quentin GISSELBRECHT, MD

SUB_INVESTIGATOR

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Ratio of creatinine decrease

    Time frame: Days 1 and 2 in kidney transplant recipients

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Charlotte POUSSARDIN, MD

CONTACT

[email protected]

33.3.69.55.16.21

Sponsors and collaborators

Lead sponsor

University Hospital, Strasbourg, France

Other

Registry information

Acronym: OPTI-PMO 2

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 2, 2025
Registry last updated
Apr 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.