Status:
NOT_YET_RECRUITING
Eduction in ImmunoSuppressive Regimen Among Kidney Transplant Recipients Patients Admitted to the Intensive Care Unit for Septic Shock and/or Acute Respiratory Failure
Lead Sponsor:
University Hospital, Strasbourg, France
Conditions:
Sepsis and Septic Shock
Acute Respiratory Failure
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Kidney transplantation is the treatment of choice for end-stage chronic kidney disease. Kidney transplantation is at the first rank of solid organ transplantation in France, with 3,376 grafts performe...
Eligibility Criteria
Inclusion
- \- Adult patients, aged 18 years-old and over,
- Kidney transplant recipients, with transplantation occurring more than 3 months prior to ICU admission
- Patients admitted to the ICU in the setting of:
- Septic shock (sepsis requiring vasopressor support, with or without hyperlactatemia),
- And/or acute respiratory failure of presumed infectious origin (invasive or non-invasive ventilation, FiO2 greater than or equal to 50%),
- Patients treated with at least an immunosuppressive bitherapy (including steroids, calcineurin inhibitors, mTOR inhibitors, azathioprine, or mycophenolate mofetil),
- Patients affiliated with a social health insurance protection scheme,
- Patients able of understanding the objectives and risks related to the research and providing a dated and signed informed consent. If patient is unable to consent: consent from relatives will be searched, and if absent, an emergency procedure will be process.
- Women of childbearing potential, provided they have a negative blood pregnancy test on the day of the inclusion visit.
Exclusion
- Minor patients,
- Patients unable to consent: under legal protection measures, patients deprived of liberty,
- Kidney transplant recipients treated with Belatacept due to the persistent effect of Belatacept, it is not possible to modulate this treatment in a short term period,
- Patients with severe chronic graft dysfunction (glomerular filtration rate \< 20 ml/min/1.73m² according to the CKD-EPI formula in the month prior to admission),
- Transplant renal recipients who have already resumed RRT (hemodialysis or peritoneal dialysis),
- Multi-organ transplant recipients,
- Pregnant women
Key Trial Info
Start Date :
February 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2029
Estimated Enrollment :
212 Patients enrolled
Trial Details
Trial ID
NCT06881927
Start Date
February 1 2026
End Date
June 1 2029
Last Update
November 18 2025
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