HYDROCORTISONE for Kidney transplant recipient | Septic shock | Acute respiratory failure (presumed infectious)

Inclusion criteria

• {"criterion_text":"- Adult patients, aged 18 years-old and over\n- Kidney transplant recipients, with transplantation occurring more than 3 months prior to ICU admission\n- Patients admitted to the ICU in the setting of: o\tSeptic shock (sepsis requiring vasopressor support, with or without hyperlactatemia), o\tAnd/or acute respiratory failure of presumed infectious origin (invasive or non-invasive ventilation, FiO2 greater than or equal to 50%),\n- Patients treated with at least an immunosuppressive bitherapy (including steroids, calcineurin inhibitors, mTOR inhibitors, azathioprine, or mycophenolate mofetil),\n- Patients affiliated with a social health insurance protection scheme\n- 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\n- Women of childbearing potential, provided they have a negative blood pregnancy test on the day of the inclusion visit"}

Exclusion criteria

• {"criterion_text":"- Minor patients\n- Patients unable to consent: under legal protection measures, patients deprived of liberty\n- 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\n- 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\n- Transplant renal recipients who have already resumed RRT (hemodialysis or peritoneal dialysis),\n- Multi-organ transplant recipients\n- Pregnant women"}

Primary endpoints

• {"endpoint_text":"- The primary endpoint is the rate of patients showing a reduction in the SOFA (Sequential Organ Failure Assessment) score of at least 4 points at day 5","definition_or_measurement_approach":"Reduction in SOFA score by at least 4 points measured using the Sequential Organ Failure Assessment (SOFA) at day 5."}

Secondary endpoints

• {"endpoint_text":"- Vital status at discharge from the ICU and at month 6","definition_or_measurement_approach":"Vital status (alive/dead) assessed at ICU discharge and at 6 months."}
• {"endpoint_text":"- Daily evolution of the SOFA score (from day 1 to day 7)","definition_or_measurement_approach":"Daily SOFA scores recorded from day 1 to day 7."}
• {"endpoint_text":"- Serum creatinine level and glomerular filtration rate (GFR, in ml/min) at discharge from the ICU, assessed by the UV/P method (urine creatinine * diuresis / plasma creatinine). Given the usual collection of 24-hour urine in intensive care, this cost-effective approach is easily achievable and is the most relevant in intensive care","definition_or_measurement_approach":"Serum creatinine and GFR at ICU discharge; GFR assessed by UV/P method (urine creatinine * diuresis / plasma creatinine), based on 24-hour urine collection."}
• {"endpoint_text":"- Dialysis status (during ICU stay and at month 6): use of dialysis, modality of dialysis, weaning from RRT at discharge between ICU discharge and month 6","definition_or_measurement_approach":"Record of use of dialysis, dialysis modality, and whether patient was weaned from renal replacement therapy during ICU stay and at 6 months."}
• {"endpoint_text":"- Histological evidence (graft biopsy) and characterization of rejection according to the Banff classification, for any sample taken between discharge from the ICU and month 6 (biopsy for cause only).","definition_or_measurement_approach":"Biopsy-proven graft rejection characterized per Banff classification for any for-cause graft biopsy taken between ICU discharge and month 6."}
• {"endpoint_text":"- Evaluation of anti-HLA immunization will be performed on a blood sample at month 6, with screening for Donor-Specific Antibodies","definition_or_measurement_approach":"Anti-HLA antibody testing on blood at month 6, including screening for donor-specific antibodies (DSA)."}
• {"endpoint_text":"- Collection of significant infection episodes from ICU discharge to month 6. An infection will be considered significant if it requires hospitalization. Additionally, during the 6-month consultation, blood replication for CMV, EBV, and BK virus and urinary replication of BK virus (assessed with Polymerase Chain Reaction tests) will be collected as part of routine care","definition_or_measurement_approach":"Collection of infection episodes requiring hospitalization from ICU discharge to 6 months; PCR testing for CMV, EBV, BK (blood) and BK (urine) at 6-month visit as part of routine care."}

France

Earliest CTIS Part Ii Submission Date

26-06-2025

Latest Decision Or Authorization Date

07-08-2025

Processing Time Days

42

Number Of Sites

10

Number Of Participants

212

Primary sponsor

Full Name

Les Hopitaux Universitaires De Strasbourg

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France