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

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What is this study about?

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.

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 randomization

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

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 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 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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Groupe Hospitalier Du Sud Ile De France	Melun	France
Centre Hospitalier Universitaire De Lille	Lille	France
CHU Grenoble Alpes	La Tronche	France

Other Sites

Site Name	City	Country
Centre Hospitalier Victor Dupouy	Argenteuil	France
Centre Hospitalier De Valenciennes	Valenciennes	France
Centre Hospitalier De Haguenau	Haguenau	France
Centre Hospitalier Universitaire d’Orléans	Orléans	France
Centre Hospitalier Universitaire De Montpellier	Montpellier	France
Centre Hospitalier Universitaire De Nantes	Nantes	France
Centre Hospitalier Universitaire Amiens Picardie	Amiens	France
Centre Hospitalier Lyon Sud	Pierre Benite	France
Hopital Beaujon	Clichy	France
Centre Hospitalier de Dieppe	Dieppe	France
Hopital Nord Franche-Comte	Belfort	France
Cxjlsv Hyuvfrirzvj Scn Exdoefrttqgcfkvtxwphdpi	Etampes	France
Cocuze Haieromysag Ueydgpvklrwfh Dt Dvwbe	Dijon	France
Groqdv Hkvfwknirpf Uhintxcxgysra Pxeeb Pemngveoytf Ep Nvjvaaagdhun	Paris	France
Hesfmacv Uibluiydzbnsqw Strgmfoejh &bfzsai Haovkyy dv Hyzbtisgtxv	STRASBOURG, Alsace	France

Trial status

Country	Status	Recruitment Start
France	Not recruiting	17.02.2022

Trial locations

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.

Investigated diseases:

Critical illness

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 ID:

2024-516021-32-00

Protocol code:

APHP200018

NCT ID:

NCT04404400

Trial Phase:

Therapeutic confirmatory (Phase III)

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

What is this study about?

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