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Study on Hydrocortisone and Fludrocortisone for Adults with Critical Illness-Related Corticosteroid Insufficiency

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a condition known as Critical Illness-Related Corticosteroid Insufficiency (CIRCI), which affects patients who are critically ill. The study aims to evaluate the effectiveness of a combination of medications, specifically Hydrocortisone Hemisuccinate and Fludrocortisone Acetate, compared to a placebo. These medications are types of corticosteroids, which are hormones that help reduce inflammation and support the body's response to stress.

Participants in the study will receive either the combination of Hydrocortisone Hemisuccinate and Fludrocortisone Acetate or a placebo. The treatment will be administered over a period of up to seven days. The study will monitor the number of days participants are alive and free from the need for a ventilator or vasopressors, which are medications that help maintain blood pressure, within 30 days after starting the treatment. The goal is to see if the combination of these medications can help improve recovery in patients with CIRCI.

In addition to the primary focus, the study will also look at other outcomes, such as the length of stay in the intensive care unit (ICU) and hospital, the rate of re-admission to the ICU, and overall survival rates at different time points. The study will also assess the safety of the treatment and any potential side effects. This research is important for understanding how to better support critically ill patients who may have insufficient levels of corticosteroids in their bodies.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the patient is required to provide informed written consent. If the patient is unable to provide consent, a legally authorized person or next of kin may do so on their behalf. In emergency situations, consent may be deferred and obtained as soon as possible.

  2. Step 2

    Randomization

    The patient is randomly assigned to receive either the treatment or a placebo. This process ensures that the study results are unbiased.

  3. Step 3

    Treatment administration

    The treatment involves the administration of hydrocortisone and fludrocortisone or their respective placebos. Hydrocortisone is given intravenously, while fludrocortisone is taken orally.

    The specific dosage and frequency of administration are determined by the study protocol and are monitored by the medical team.

  4. Step 4

    Monitoring and assessment

    The patient's health is closely monitored throughout the study. This includes tracking the number of days the patient is free from mechanical ventilation and vasopressor treatment within 30 days after randomization.

    Additional assessments include mortality rates at various intervals, the number of days without renal replacement therapy, and the patient's overall health status using specific questionnaires.

  5. Step 5

    Completion of study participation

    The study participation concludes after the specified monitoring period, which includes assessments up to 180 days post-randomization.

    The patient's data is analyzed to determine the effectiveness of the treatment compared to the placebo.

Who can join the trial?

5 criteria

  • Must be an adult (18 years or older).
  • Must be hospitalized in an intensive care unit (ICU).
  • Must have a SOFA score of 4 or higher for at least 6 consecutive hours. The SOFA score is a way to measure how well the body's organs are working.
  • Must provide written consent to participate. If the patient cannot give consent, a legally authorized person or next of kin can do so. If no one is available, the patient can still be included, but consent must be obtained as soon as possible.
  • Must be affiliated with a social security system or have universal health coverage.

Who cannot join the trial?

5 criteria

  • Patients who are not critically ill or do not have a condition called **CIRCI**. CIRCI stands for **Critical Illness Related Corticosteroid Insufficiency**, which is a condition where the body does not produce enough of certain hormones during a severe illness.
  • Patients who are not in the **ICU**. ICU stands for **Intensive Care Unit**, which is a special department in a hospital for people who are very sick and need close monitoring.
  • Patients who are not adults. This means the study is only for people who are 18 years or older.
  • Patients who are not able to breathe on their own and need a machine called a **ventilator** to help them breathe.
  • Patients who are not using medications called **vasopressors**. Vasopressors are drugs that help raise blood pressure in people who have very low blood pressure.
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Investigated drugs

  • Hydrocortisone

    is a medication used in this trial to help manage inflammation and support the body in dealing with stress, especially in critically ill patients. It is a type of corticosteroid that can help improve the body's response to illness by reducing inflammation and supporting blood pressure.

  • Fludrocortisone

    is another corticosteroid used in the trial. It helps maintain the balance of water and salts in the body, which is crucial for patients with critical illness-related corticosteroid insufficiency. This medication works alongside hydrocortisone to support the body's functions during severe illness.

What is already known about the treatment

  • Hydrocortisone

    This medication is administered intravenously and is used in the treatment of critically ill patients with corticosteroid insufficiency. It is currently being studied in clinical trials to evaluate its effectiveness in reducing the need for ventilators and vasopressors in ICU patients. Hydrocortisone is primarily indicated for conditions where the body does not produce enough corticosteroids. It works by mimicking the effects of cortisol, a natural hormone, to reduce inflammation and support various bodily functions. It is classified as a corticosteroid.

  • Fludrocortisone

    This medication is taken orally and is used alongside hydrocortisone in the treatment of critically ill patients with corticosteroid insufficiency. It is being evaluated in clinical trials to determine its efficacy in improving outcomes for ICU patients. Fludrocortisone is mainly used to help maintain proper salt and water balance in the body. It acts by mimicking the hormone aldosterone, which helps regulate sodium and potassium levels. It is classified as a mineralocorticoid.

Investigated diseases

Critical Illness-Related Corticosteroid Insufficiency (CIRCI) – This condition occurs in critically ill patients when the body is unable to produce adequate levels of corticosteroids, which are essential for managing stress and inflammation. It often arises during severe illnesses or injuries, leading to an inadequate response to stress. Patients with CIRCI may experience low blood pressure, difficulty maintaining blood sugar levels, and an increased need for mechanical ventilation or vasopressors. The condition can complicate the management of critically ill patients, as the body's normal stress response is impaired. It is typically identified in intensive care settings, where patients require close monitoring and support. CIRCI can affect the overall recovery process, making it a significant concern in critical care medicine.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-516021-32-00Protocol codeAPHP200018Estimated enrolment3 276 patientsSponsorAssistance Publique Hopitaux De Paris

sourced from the EU Clinical Trials Register and site verification

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