HORNbILL. HydrOcortisone and fludRocortisoNe for critical ILLness-related corticosteroid insufficiency
The HORNbILL study is investigating treatments for seriously ill patients in intensive care who have a condition called critical illness-related corticosteroid insufficiency (CIRCI). This means their body isn't producing enough of certain stress hormones naturally. The study wants to see if giving patients specific hormone medicines, such as hydrocortisone and fludrocortisone, can help them recover faster. Researchers will measure how many days patients can breathe on their own and don't need medicines to support their blood pressure. The goal is to find better ways to help critically ill patients get well sooner and leave intensive care. The study compares these treatments to dummy medicines (placebos) to understand their effectiveness.
At a glance
What is this study about?
When people become very unwell, especially in intensive care, their bodies are under a lot of stress. Sometimes, their adrenal glands, which are small glands above the kidneys, don't make enough of certain important hormones, like cortisol. This condition is called critical illness-related corticosteroid insufficiency, or CIRCI for short. These hormones are essential for helping the body cope with stress, control blood pressure, and manage swelling.
The HORNbILL study is looking into whether giving patients extra doses of these hormones, specifically hydrocortisone and fludrocortisone, can help them get better. Hydrocortisone is similar to cortisol, and fludrocortisone helps balance body fluids and blood pressure. Researchers want to see if these treatments help patients reduce their need for breathing machines (ventilators) and medicines that support their blood pressure (vasopressors) more quickly. Getting off these supports sooner is a good sign that a patient is recovering well and can potentially lead to a quicker discharge from intensive care.
This study is in a late stage, known as Phase III, which means it’s a detailed investigation into whether these treatments are safe and effective. By comparing these hormone treatments to 'dummy' medicines (placebos), the researchers hope to clearly understand if they make a real difference to patient recovery. The main goal is to find out if patients receiving these hormones have more days where they can breathe on their own and don't need blood pressure support, within the first 30 days of treatment. This research is important because it could lead to better ways of caring for very sick people in the intensive care unit.
Key takeaways
- The study aims to improve recovery for critically ill patients in intensive care.
- It's testing if hormone medicines (hydrocortisone, fludrocortisone) help patients get off breathing machines and blood pressure support faster.
- Patients will be randomly assigned to receive either the study medicines or 'dummy' medicines (placebos).
- The main goal is to see how many days patients can breathe on their own and don't need blood pressure support within 30 days.
- Doctors will closely monitor all participants for their recovery and any potential side effects.
- Participation is voluntary, and you can withdraw at any time without affecting your care.
Who may be eligible?
This study is looking for adults who are 18 years old or older. Both men and women can take part. The most important requirement is that you must be critically ill and in intensive care, and doctors believe you might have critical illness-related corticosteroid insufficiency (CIRCI).
Doctors participating in the study will check if you meet all the specific health requirements. They will look at your medical condition and other factors to make sure that taking part in the study is appropriate and safe for you. This ensures that the study is testing the treatments on the right group of patients.
- Are you 18 years old or older?
- Are you currently critically ill and in an intensive care unit?
- Do doctors suspect you have a condition called critical illness-related corticosteroid insufficiency (CIRCI)?
- Have your doctors confirmed that you meet all the specific health criteria for the study?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you or your family agree for you to take part in this study, you would be randomly assigned to receive either the study medicines (hydrocortisone, fludrocortisone, or a combination) or 'dummy' medicines (placebos). You wouldn't know which one you are getting, and neither would your doctors. Doctors and nurses would continue to provide your usual intensive care treatment.
The study would involve close monitoring of your health over 30 days and then further checks up to 180 days after starting the study. This includes how long you need a breathing machine or blood pressure support, and your general recovery. Researchers would also look at your progress in the intensive care unit and after leaving the hospital, as well as checking for any side effects. There wouldn't be additional visits or appointments beyond what your intensive care doctors would normally do for your condition.
Potential risks and benefits
Locations (1)
- —France
Common questions
What is CIRCI?
CIRCI stands for critical illness-related corticosteroid insufficiency. It means your body isn't making enough stress hormones when you are very ill, which can affect your recovery.
What are hydrocortisone and fludrocortisone?
These are medicines that act like the natural stress hormones your body makes. They are being tested to see if they help critically ill patients.
What is a 'placebo'?
A placebo is a 'dummy' medicine that looks like the real treatment but contains no active drug. It helps researchers understand if the active medicine truly works.
Why 30 days specifically?
The first 30 days are a key period to see how quickly patients recover, particularly how soon they can breathe on their own and don't need blood pressure support.
What happens if I or my family decide to stop participating?
You can withdraw from the study at any time. Your decision will not affect the quality of medical care you receive.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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