RecruitingPHASE3INTERVENTIONAL

Hydrocortisone and Fludrocortisone for Critical Illness-related Corticosteroid Insufficiency

This study looks at adults in intensive care who have a condition called Critical Illness-Related Corticosteroid Insufficiency (CIRCI). This means their body isn't making enough of certain hormones to cope with severe illness. Researchers want to see if giving a combination of hydrocortisone and fludrocortisone – which are like the body's natural stress hormones – can help these patients get better. Some patients will receive these medications, while others will get a placebo (a dummy drug) to allow for a fair comparison. The aim is to find out if this treatment is safe and effective in improving recovery for those who are seriously ill but don't have septic shock.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Assistance Publique - Hôpitaux de Paris

Enrolment target

1,092

Start

17 Feb 2022

Estimated completion

01 Feb 2026

Critical Illness Related Corticosteroids Insufficiency

What is this study about?

When someone is critically ill, their body normally produces stress hormones to help them cope. But sometimes, especially during very severe illness, the body can struggle to produce enough of these vital hormones, or the hormones might not work properly. This condition is called Critical Illness-Related Corticosteroid Insufficiency, or CIRCI for short.

This study is designed to investigate whether giving two specific medications – hydrocortisone and fludrocortisone – can help adults in intensive care who have CIRCI. These medications are similar to the natural stress hormones the body produces. Doctors want to see if this treatment can improve how quickly people recover from critical illness, especially if they don't have another severe condition called septic shock, which has already been studied.

The research includes comparing the medication combination with a placebo, which is a treatment that looks the same but contains no active drug. This is a standard way to test new treatments, as it helps doctors understand if any improvements are genuinely due to the medications or other factors. By taking part, patients could help doctors learn more about the best ways to treat CIRCI in the future.

Key takeaways

Tests if hydrocortisone and fludrocortisone help adults in intensive care with CIRCI.
Compares the drug combination to a placebo (dummy treatment).
Aims to improve recovery for critically ill patients without septic shock.
Participants are closely monitored for 90 days.
Participation is voluntary and you can withdraw anytime.

Who may be eligible?

This study is looking for adults aged 18 or over who are currently in intensive care and have a severe illness. To be considered, your illness must be serious enough to warrant a specific score on a medical assessment (SOFA score of 4 or higher) for at least six hours. You or your family will need to give written permission for you to join the study.

However, there are several reasons why someone might not be able to join. For example, if you already have a known long-term problem with your adrenal glands (which produce these hormones), or if doctors expect you might pass away within 48 hours, you wouldn't be eligible. Also, if you have certain infections like active tuberculosis, a severe fungal infection, or some viral infections, you cannot participate. If you're pregnant or breastfeeding, or if you're already taking high doses of similar steroid medications for a long time, you won't be able to join this particular study.

The study also cannot include patients with severe complications of diabetes like diabetic ketoacidosis, or anyone receiving treatment for septic shock. If you're involved in another study looking at similar treatments or conditions, you also wouldn't be able to join this one.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you an adult aged 18 or older?
Are you currently in an intensive care unit (ICU)?
Do you or your family agree to give written permission to join?
Do you NOT have a long-term problem with your adrenal glands?
Are you NOT pregnant or breastfeeding?
Are you NOT currently receiving treatment for septic shock?

Answer every question to see your result.

What does participation involve?

If you are eligible and agree to take part, you would be randomly assigned to receive either the study medications (hydrocortisone and fludrocortisone) or a placebo (a dummy treatment) through an IV drip. The medical team will monitor your health closely throughout your time in the intensive care unit, as they would for any critically ill patient.

For those who are not found to have CIRCI but still meet other study criteria, there may be an option to be part of an observational group. This means doctors would simply follow your progress and collect information on your health for 90 days, without giving you any experimental medication. The total duration of active treatment in the study would depend on your medical needs, but all participants would be followed up for a period of 90 days to track their recovery and health outcomes.

Potential risks and benefits

Participating in this study might offer potential benefits if the medications prove to be effective in treating CIRCI. However, like all medications, hydrocortisone and fludrocortisone can have side effects, which the medical team will monitor closely. There might also be risks associated with the extra tests or procedures required for the study, although these would be kept to a minimum and explained beforehand. It's important to remember that you have the right to withdraw from the study at any time, for any reason, without affecting your usual medical care.

Locations (1)

General Intensive care Unit, Raymond Poincaré Hospital, APHP
Verified postcode
Garches, France· Recruiting

Common questions

What is CIRCI?

CIRCI stands for Critical Illness-Related Corticosteroid Insufficiency. It means your body isn't making enough of certain hormones to handle severe illness.

What medications are being tested?

The study is testing a combination of hydrocortisone and fludrocortisone, which are treatments that act like your body's natural stress hormones.

Will I definitely get the active drugs?

No, you will be randomly assigned to either receive the active drugs or a placebo (a dummy drug). This helps researchers fairly compare the effects.

How long will I be involved in the study?

You'll be closely monitored while in intensive care, and all participants will have their health followed for 90 days after joining the study.

What is a placebo?

A placebo is a treatment that looks exactly like the real medication but doesn't contain any active drug. It helps ensure the study results are accurate.

How to find out more

Nicholas HEMING, MD, PhD

nicholas.heming@aphp.fr + 33 1 47 10 77 78 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.