Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

Rapid rEcognition of COrticosteroid Resistant or sentive Sepsis - RECORDS A Multicentre Concealed‐Allocation Multi-arms Blinded Randomized Controlled Trial to Identify the Best Sepsis Population for Corticotherapy

The RECORDS study is a large research project aiming to improve how we treat sepsis, a very serious reaction to an infection, in intensive care units. Doctors are trying to find out if certain steroid medications, specifically hydrocortisone, betamethasone, or fludrocortisone, can help patients recover better. They want to see if these medicines can reduce the time patients spend on life support or in hospital, and if they can improve survival. The study will also compare these active drugs with a placebo, which looks like the real medicine but contains no active ingredient, to understand their true effects. It's an important step to find the best treatments for people fighting severe infections.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Assistance Publique Hopitaux De Paris

Enrolment target

1,800

Start

05 Nov 2024

Patients admitted to the ICU proven or suspected infection as the main diagnosis.

What is this study about?

When someone has a very serious infection, their body can react in a dangerous way called sepsis. This can lead to organs not working properly, and people often need to be treated in an intensive care unit (ICU) and sometimes require life support machines. Doctors are always looking for better ways to help patients with sepsis recover fully.

This study, called RECORDS, is exploring different steroid medicines to see if they can improve recovery for people with sepsis. Steroids are powerful drugs that can reduce inflammation in the body. The study wants to find out if using these particular steroids – hydrocortisone, betamethasone, or fludrocortisone – can help patients get better faster, spend less time on breathing machines or other life support, and ultimately lead to a more complete recovery. Some patients in the study will also receive a dummy pill (placebo) to help doctors accurately compare the effects of the active medicines.

This type of research is really important because it helps doctors understand which treatments work best for different people with sepsis. By taking part, patients are contributing to medical knowledge that could improve care for many others in the future. The aim is to find effective ways to help people fight off these serious infections and get back to their normal lives.

Key takeaways

The study looks at different steroid medicines for severe infections (sepsis) in ICU.
It aims to find out if these steroids help patients recover better and faster.
Participants will receive either a steroid medicine or a look-alike dummy drug (placebo).
Doctors will closely monitor participants' health, including organ function and breathing support needs.
The study helps improve future treatments for sepsis.
Your medical care will not be affected if you choose not to join or decide to leave the study.

Who may be eligible?

To be considered for this study, you would need to be 18 years old or older. The study is open to both men and women.

The main requirement is that you have been admitted to an intensive care unit (ICU) because you have a confirmed or suspected serious infection, which doctors believe is the main reason you are unwell.

The research team will carefully check other details about your health to make sure the study is a safe and suitable option for you. Not everyone with a serious infection will be able to join, as there might be other medical reasons that mean the study isn't right for your specific situation.

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 18 years old or older?
Have you been admitted to intensive care?
Do doctors suspect or have they confirmed you have a serious infection as the main reason you are unwell?
Are you able to provide consent, or can a legal representative give consent on your behalf?

Answer every question to see your result.

What does participation involve?

If you are asked to take part in this study, you would receive either one of the steroid medications (betamethasone, hydrocortisone, or fludrocortisone) or a placebo, which looks like the medicine but contains no active drug. This would be given while you are in the intensive care unit.

The study would involve doctors and nurses closely monitoring your health and recovery over time. They would track things like how well your organs are working, if you need breathing support, and whether you need medicines to support your blood pressure. This monitoring would happen while you're in the ICU and also afterwards. Researchers would follow your progress for up to 90 days after you join the study, and some aspects, like your general health and quality of life, would be checked again at 6 months. There might also be a check-up for hospital readmissions up to 180 days (about 6 months) later.

Potential risks and benefits

Taking part in a study like this could potentially help future patients by finding better ways to treat sepsis. If the steroid medicines work, participants might recover faster or spend less time on life support. However, like all medicines, steroids can have side effects, and some patients might receive a placebo and get no direct benefit from the study drug. All participants will receive standard medical care for sepsis. You are free to withdraw from the study at any time without affecting your medical treatment.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
France

Common questions

What is sepsis?

Sepsis is a very serious reaction to an infection where your body's immune system overreacts, leading to inflammation and organ damage. It's a medical emergency.

What is a 'steroid' in this study?

In this study, 'steroids' refer to specific medications like hydrocortisone or betamethasone. These are powerful drugs that can help reduce severe inflammation in the body during conditions like sepsis.

What is a placebo?

A placebo is a treatment that looks exactly like the real medicine but contains no active drug. It helps researchers understand if the real medicine is truly making a difference compared to getting no active treatment.

Will I know if I'm getting a steroid or the placebo?

No, in this study, neither you nor your doctors will know if you are receiving an active steroid medicine or the placebo. This is called 'blinding' and helps ensure the results are fair.

How long will the study follow my progress?

The study will closely monitor your health for up to 90 days after you join. Some checks on your overall health and quality of life may continue up to 6 months, and they will also check for hospital readmissions for up to 180 days.