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Sepsis and Septic Shock / Hydrocortisone Hemisuccinate: 200 mg per day. / reduction of the level of immunosuppression · Phase 4 Trial
ClinicalTrials.gov · August 20, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a Phase 4 interventional trial registration for kidney transplant recipients admitted to intensive care with septic shock and/or acute respiratory failure. The study compares hydrocortisone hemisuccinate plus immunosuppression reduction against standard care, with primary endpoint of SOFA score change ≥4 points by day 5. No results are yet available; the study is actively recruiting.
Phase 4, Interventional, Randomized, Parallel, Open label, Supportive Care purpose. Sepsis and Septic Shock, Acute Respiratory Failure, Kidney Transplant Recipients, Immunosuppressive Agents; age from 18 Years. Intervention: reduction of the level of immunosuppression. Compared with: usual immunosuppression maintenance — Active Comparator. n = 212. 1 site: France.
This is a Phase 4 interventional trial registration for kidney transplant recipients admitted to intensive care with septic shock and/or acute respiratory failure. The study compares hydrocortisone hemisuccinate plus immunosuppression reduction against standard care, with primary endpoint of SOFA score change ≥4 points by day 5. No results are yet available; the study is actively recruiting.
Primary outcome measure is SOFA score change, a physiologic endpoint; hard clinical outcomes (mortality, graft survival, rejection) not specified as primary measures.
The source did not state who this applies to in practice.
This is a Phase 4 interventional trial registration with no results posted; the study is actively recruiting and has not yet reported outcomes, making it early-stage evidence.
As stated by the source record.
Quoted from the source exactly as published.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT06881927). This is a study registration, not published results. Lead sponsor: University Hospital, Strasbourg, France. Recruitment status: RECRUITING. Phase: PHASE4. Study type: INTERVENTIONAL. Enrollment: 212 participants (ESTIMATED). Conditions: Sepsis and Septic Shock, Acute Respiratory Failure, Kidney Transplant Recipients, Immunosuppressive Agents. Interventions: DRUG: Hydrocortisone Hemisuccinate: 200 mg per day.; OTHER: reduction of the level of immunosuppression. Primary outcome measures: The primary endpoint is the rate of patients showing a change in the SOFA (Sequential Organ Failure Assessment) score of at least 4 points , Day 5. Brief 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.
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