Reducing Immunosuppressive Treatment in Kidney Transplant Patients Admitted to ICU for Septic Shock or Acute Respiratory Failure A Phase IV Multicenter Randomized Trial

What this Trial Is About

Kidney transplantation is a common treatment for end-stage chronic kidney disease, with many grafts performed annually in France. Immunosuppressive therapy is necessary to prevent graft rejection but increases the risk of infections and other complications. Up to 10% of kidney transplant recipients may require intensive care unit ICU admission due to septic shock or acute respiratory failure, conditions associated with high mortality and potential worsening of kidney graft function. The study aims to find the best way to manage immunosuppressive treatments in these critical situations to support patient recovery without increasing rejection risk. This trial compares two approaches for immunosuppressive therapy in kidney transplant patients admitted to the ICU for septic shock or acute respiratory failure. One group will have their usual immunosuppressive drugs stopped and receive hydrocortisone hemisuccinate 200 mg per day via slow intravenous injection. The other group will continue their standard immunosuppressive medications, including calcineurin inhibitors, mTOR inhibitors, azathioprine, or mycophenolate mofetil, with hydrocortisone also given. Dosage adjustments of some drugs may be made by clinicians as needed. Participants will be monitored for changes in organ function, specifically measuring the Sequential Organ Failure Assessment SOFA score by Day 5. Researchers will assess treatment impacts on recovery, graft function, and safety. The study involves random assignment to treatment groups and includes consent processes. The total study period and follow-up details are not specified, but the primary outcome focuses on early organ function changes after ICU admission and treatment modification.

Eduction in ImmunoSuppressive Regimen Among Kidney Transplant Recipients Patients Admitted to the Intensive Care Unit for Septic Shock and/or Acute Respiratory Failure