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

Launched by UNIVERSITY HOSPITAL, STRASBOURG, FRANCE · Mar 17, 2025

Keywords

ClinConnect Summary

This clinical trial is investigating whether reducing the amount of immunosuppressive medications can help kidney transplant patients recover better when they are admitted to the Intensive Care Unit (ICU) due to serious conditions like septic shock or acute respiratory failure. Immunosuppressive drugs are necessary to prevent the body from rejecting the transplanted kidney, but they can weaken the immune system and lead to complications. The researchers believe that lowering these medications during critical illness might support recovery without increasing the risk of kidney rejection or affecting long-term kidney function.

To participate in this trial, patients must be over 18 years old and have received a kidney transplant at least three months before being admitted to the ICU. They should be experiencing septic shock or severe respiratory failure likely caused by an infection and must be using certain immunosuppressive treatments. Patients will be carefully monitored throughout the study to ensure their safety and to assess how changes in medication impact their recovery. This trial is not yet recruiting participants, but it aims to provide valuable insights into the best care for kidney transplant recipients facing serious health challenges.

Gender

ALL

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