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New treatment option for Sepsis and Septic Shock
Official title Eduction in ImmunoSuppressive Regimen Among Kidney Transplant Recipients Patients Admitted to the Intensive Care Unit for Septic Shock and/or Acute Respiratory Failure
ClinicalTrials.gov ID: NCT06881927
What this study is testing
What is Hydrocortisone Hemisuccinate: 200 mg per day.?
Hydrocortisone Hemisuccinate: 200 mg per day. is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for sepsis and septic shock.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- \- 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%),
You likely can't join if
- 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...
- 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...
- Transplant renal recipients who have already resumed RRT (hemodialysis or peritoneal dialysis),
- Multi-organ transplant recipients,
See the full eligibility 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...
- Women of childbearing potential, provided they have a negative blood pregnancy test on the day of the inclusion visit.
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Strasbourg, France
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Strasbourg, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.