AuthorisedTherapeutic confirmatory (Phase III)Interventional

ADRESS : Efficacy of the Alpha 2 agonist dexmedetomidine for sympathetic Deactivation in REfractory Septic Shock: a randomized, controlled trial

This study, called ADRESS, is looking into a medication called dexmedetomidine, which helps calm the body's overactive stress response in people with very severe blood poisoning (septic shock). Septic shock is a life-threatening condition where the body's reaction to an infection causes dangerously low blood pressure and organ damage. The main goal is to find out if patients who receive dexmedetomidine, in addition to standard care, have a better chance of surviving 30 days after starting treatment. Researchers will also look at how much other medicines are needed, how quickly blood pressure improves, and how long people stay in the intensive care unit. This research aims to see if current treatments for septic shock can be improved.

At a glance

Status

Authorised

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Hospices Civils De Lyon

Enrolment target

360

Start

24 Apr 2026

Septic shock

What is this study about?

When someone has a severe infection, their body can react very strongly, leading to a life-threatening condition called septic shock. This can cause dangerously low blood pressure and stop organs from working properly. Doctors often use medicines to raise blood pressure and fight the infection, but sometimes these aren't enough, or they have side effects.

This study is testing a medicine called dexmedetomidine. It's already used for calming patients, but doctors want to see if it can also help to 'switch off' some of the body's overactive stress responses that happen in septic shock. By doing this, they hope to improve blood pressure, reduce the need for other strong medicines, and ultimately help people recover better.

The ADRESS study is a 'Phase III' trial, which means it's a large, important step to confirm if this treatment works well and is safe. The results will help doctors understand if dexmedetomidine could become a new, valuable part of how we treat septic shock, potentially improving outcomes for many patients.

Key takeaways

This study investigates a medicine for severe blood poisoning (septic shock).
It aims to see if dexmedetomidine improves survival and recovery.
Participation involves receiving the study drug or a dummy treatment.
Close monitoring over 90 days is part of the study.
The goal is to find better treatments for this serious condition.

Who may be eligible?

This study is looking for adults who are at least 18 years old and are currently experiencing septic shock. Septic shock is a very serious condition, and the medical team will make sure you fit the specific criteria for the study.

Because this is a specific medical condition being studied, there are likely other detailed medical requirements that your doctors will check. These might include certain blood test results, how long you've been unwell, and if you have other serious health problems.

During your time in the Intensive Care Unit, your medical team will assess whether this study is suitable and safe for you. They will discuss all the details with you or your family.

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 at least 18 years old?
Do you have a diagnosis of septic shock?
Are you currently in an Intensive Care Unit (ICU) setting?
Is your medical team considering all possible treatment options for your condition?

Answer every question to see your result.

What does participation involve?

If you are eligible and agree to take part, you would receive either the study medicine (dexmedetomidine) or a dummy treatment (placebo), alongside all your usual care for septic shock. This is given as a continuous drip (infusion).

Throughout your time in the hospital, and especially in the intensive care unit, the medical team would carefully monitor your vital signs (like blood pressure and heart rate), blood tests, and how you are responding to treatment. This includes regular checks at specific times like 6, 12, and 24 hours, and then for up to 30 days.

After leaving the intensive care unit, researchers will continue to check on your health at 30 days and again at 90 days after you started the study, to see how you are recovering overall. The full length of participation, including follow-up, would be up to 90 days.

Potential risks and benefits

Taking part in this study could potentially help advance medical understanding of how to treat septic shock, which might benefit future patients. For you, there's a chance the study medicine could help your condition or reduce the need for other strong medications. However, like all medicines, dexmedetomidine has potential side effects, such as a slower heart rate. You will be closely monitored for any adverse reactions, and your safety is the top priority. There's also a chance the study medicine may not work for you, or you might receive the dummy treatment and not experience any direct benefit. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

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 septic shock?

Septic shock is a very severe reaction to an infection where your body overreacts, causing dangerously low blood pressure and organs to struggle. It's a medical emergency.

What is dexmedetomidine?

It's a medicine often used to calm patients. In this study, doctors are investigating if it can also help control the body's extreme stress response in septic shock.

Will I definitely get the new medicine?

No, because it's a 'randomised' study, you will either receive the study drug or a placebo (dummy treatment), along with your usual care. You won't know which one you're getting.

How long will I be in the study?

You'll be closely monitored during your hospital stay, and then your health will be checked at 30 days and 90 days after starting the treatment.

Will taking part affect my usual treatment?

No, you will still receive all the standard, necessary medical care for your septic shock, regardless of whether you are in the study.