Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 5:05 AM
Ignite Modification Date:
2025-12-25 @ 5:05 AM
NCT ID:
NCT06881927
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06881927
Study Brief:
Protocol Section:
NCT06881927