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Eduction in ImmunoSuppressive Regimen Among Kidney Transplant Recipients Patients Admitted to the Intensive Care Unit for Septic Shock and/or Acute Respiratory Failure
Sponsor: University Hospital, Strasbourg, France
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 performed in 2022. Immunosuppressive therapy, required to prevent graft rejection, exposes graft recipients to complications related to decreased immunity, including opportunistic infections and neoplastic complications. After the earlt post-transplantation period, up to 10% of kidney transplant recipients will require admission to the intensive care unit (ICU). The main reasons for admission are septic shock and acute hypoxemic respiratory failure. ICU stay has a significant impact on these patients with a mortality rate reaching 40%, that remains increased even after ICU discharge. Furthermore, an impact on graft function has been demonstrated, with deterioration of graft function in 1/3 of patients, and among those, up to one in two will require resumption of renal replacement therapy (RRT). Although the occurrence of septic shock or acute respiratory failure related to an infection is more common and severe, the optimal management strategy for immunosuppressors is not defined in kidney transplant recipients admitted to the ICU in those settings. Maintain a high level of immunosuppressive therapies may hinder the recovery from the acute critical condition. Furthermore, these treatments have a narrow therapeutic index; for instance, the management of calcineurin inhibitors is challenging in the ICU due to pharmacodynamic changes associated with the acute situation (distribution volume, organ failure) and the numerous potential drug interactions that carry inherent risks of overdose. the investigators hypothesize that a reduction in the level of immunosuppressive treatments could promote recovery in kidney transplant recipients admitted to the ICU for septic shock and/or acute hypoxemic respiratory failure, without adversely affecting the risk of rejection or long-term renal prognosis.
Official title: Reduction in ImmunoSuppressive Regimen Among Kidney Transplant Recipients Patients Admitted to the Intensive Care Unit for Septic Shock and/or Acute Respiratory Failure: a Multicenter, Open-label, Phase IIb Randomized Controlled Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
212
Start Date
2026-02-01
Completion Date
2029-06-01
Last Updated
2025-11-18
Healthy Volunteers
No
Conditions
Interventions
Hydrocortisone Hemisuccinate: 200 mg per day.
The hydrocortisone hemisuccinate is a powder and solvent for injectable solution at 100 mg. The powder must be dissolved in the solvent to ensure final isotonicity. The solution must be used within 24 hours. The injection is performed as a slow direct IV injection, either via an electric syringe pump or as a bolus of 50 mg every 6 hours
reduction of the level of immunosuppression
In this arm, the usual immunosuppressive treatment of the patients will be discontinued. Patients will receive hydrocortisone hemisuccinate 200 mg per day (slow direct intraveinous injection of 50 mg four times a day, or through an electric syringe pump).