Education on Immunosuppressive Therapy Reduction in Kidney Transplant Recipients in ICU with Sepsis or Respiratory Failure

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 4 interventional trial investigates whether a structured approach to moderating immunosuppression, alongside hydrocortisone 200 mg daily, can improve outcomes for kidney transplant recipients admitted to the ICU with septic shock or acute respiratory failure. The protocol includes reducing immunosuppressive exposure and providing education to care teams and patients to guide management. Eligible adults who are at least 3 months post-transplant and meet ICU admission criteria are enrolled, with consent obtained directly or via an approved emergency process. Primary endpoints may include safety and graft function, infection rates, and ICU outcomes, while secondary endpoints may assess mortality and need for renal replacement therapy. The study is conducted at Hôpitaux Universitaires de Strasbourg as the lead site.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* \- 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 Criteria:

* 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

Where it's running

• Hôpitaux Universitaires de Strasbourg
  Strasbourg, France Recruiting

Study contacts

• Study coordinator: Sarah Hustache
• Email: dpidric@chru-strasbourg.fr
• Phone: 00338811

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.