Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not yet recruiting

Efficacy of dapagliflozin in adult patients with septic shock and microcirculatory dysfunction

Verified siteRegistered drug
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

Patients with Septic shock, a serious condition where a severe infection causes dangerously low blood pressure, often develop problems in the tiny blood vessels that supply organs, known as microcirculatory dysfunction. The trial evaluates a medication called dapagliflozin, which is taken as a small tablet and is thought to protect blood vessels, compared with a matching placebo.

The purpose of the study is to determine whether adding dapagliflozin can lower the chance of death, reduce the need for a vasopressor (a drug that helps raise blood pressure), and decrease the requirement for renal replacement therapy (a machine that performs the work of the kidneys). Participants are randomly assigned to receive either the study drug or placebo for a short period while they are in the hospital, and they are followed for about four weeks to see how they recover.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Enrollment and randomization

    After you agree to take part, basic health information and laboratory results are recorded.

    You are then assigned by a computer to receive either dapagliflozin 10 mg tablets or a matching placebo without knowing which one you receive.

  2. Step 2

    Start of study medication

    The assigned tablet is taken by mouth once each day; if you cannot swallow, it may be given through a nasogastric tube or a gastrostomy tube.

    The dose is 10 mg of dapagliflozin (or identical placebo) and you continue taking it for the duration of the trial, which lasts up to 28 days after randomization.

  3. Step 3

    Daily clinical monitoring

    Each day you will have your blood pressure, heart rate, breathing rate and other vital signs checked.

    Blood samples may be taken to assess kidney function and other laboratory values.

    These measurements help the study team evaluate the effect of the medication on your condition.

  4. Step 4

    Assessment of vasopressor weaning

    On day 5 of the trial, doctors will evaluate whether the medication that supports your blood pressure, called a vasopressor, can be reduced or stopped.

    Your response to this assessment is recorded as part of the study outcome.

  5. Step 5

    Monitoring for renal replacement therapy

    Throughout the 28‑day period, the study team watches for signs that your kidneys are not working well enough.

    If kidney failure occurs, you may start renal replacement therapy (a treatment such as dialysis) and this event is documented.

  6. Step 6

    Final follow‑up at day 28

    On day 28, the study records whether you are alive, whether the vasopressor has been successfully stopped, and whether you required renal replacement therapy during the trial.

    These results are used to determine the overall effect of the medication.

Who can join the trial?

6 criteria

  • Age 18 or older – you must be an adult.
  • You must be staying in an intensive care unit (ICU) because of septic shock as defined by the Sepsis‑3 definition (a serious infection that causes dangerously low blood pressure and organ problems). The septic shock has to be the main reason you were admitted.
  • Your septic shock must have been diagnosed less than 12 hours before you are considered for the study.
  • You need to show signs of poor blood flow to the skin, such as skin mottling (a patchy, purple‑red discoloration) with a mottling score of 2 or higher, and/or a capillary refill time longer than 3 seconds (the time it takes for color to return to a fingertip after pressing it).
  • You must have social health insurance or a close family member who is covered by such insurance.
  • You or your legal representative must sign an informed consent form agreeing to join the study. If immediate consent is not possible, an emergency procedure will be used according to the law.

Who cannot join the trial?

14 criteria

  • Unable to take medication by mouth at the beginning (for example, after emergency stomach surgery or a sudden blockage of blood flow to the intestines).
  • Having a do‑not‑resuscitate (DNR) order at the time of joining the study, which means no life‑saving measures will be started if the heart stops.
  • Participating in another experimental treatment study at the same time.
  • Being in prison, under guardianship, conservatorship, or any other legal protection that limits personal freedom.
  • Being pregnant or breastfeeding.
  • Having any contraindication to dapagliflozin, which means a medical reason that makes the drug unsafe for you.
  • Having taken an SGLT‑2 inhibitor (a type of diabetes medicine) before arriving in the intensive care unit.
  • Having very low blood sugar (hypoglycemia) lower than 0.5 g/L (2.75 mmol/L).
  • Having end‑stage kidney disease and receiving regular dialysis (a machine that cleans the blood when kidneys no longer work).
  • Having a history of type 1 diabetes, for which gliflozin drugs are not approved.
  • Having a history of diabetic ketoacidosis, a serious condition where the blood becomes acidic because of insufficient insulin.
  • Having an active infection called Fournier’s gangrene, which affects the genital or anal area.
  • Currently taking lithium, a medication used for mood disorders.
  • Having severe liver scarring called cirrhosis at the Child‑C stage, the most advanced level of liver disease.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not yet recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

Forxiga (dapagliflozin) is a tablet taken by mouth (or through a feeding tube) that belongs to a group of medicines called SGLT‑2 inhibitors. It helps the kidneys get rid of extra sugar and water in the urine. In this trial, the drug is being tested to see if it can protect tiny blood vessels and improve blood flow in patients who are in septic shock and have problems with the small vessels that supply oxygen to organs. Researchers want to find out whether giving this medication can lower the chance of death, help patients stop using medications that raise blood pressure (vasopressors), and reduce the need for kidney‑replacement therapy such as dialysis.

What is already known about the treatment

Forxiga 10 mg film-coated tablets - This medication is taken by mouth as a film‑coated tablet and can also be given through a nasogastric or gastrostomy tube if needed. It is an approved drug for treating type 2 diabetes and is now being studied for use in patients with septic shock and poor blood flow. It works by blocking a protein called SGLT‑2 in the kidneys, which lets excess sugar leave the body in the urine and helps the body get rid of extra fluid, supporting blood vessels. Dapagliflozin belongs to the class of SGLT‑2 inhibitor oral diabetes medicines.

Investigated diseases

Septic shock - A severe condition that occurs when an infection triggers a widespread inflammatory response, causing the blood vessels to dilate and blood pressure to fall sharply. This drop in pressure reduces blood flow to vital organs, leading to progressive organ dysfunction. As the body’s circulatory system struggles to maintain perfusion, patients may develop worsening kidney, lung, and heart function. Without appropriate support, the condition can continue to deteriorate over several days.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-524820-23-00Protocol codeRC25_0052Estimated enrolment654 patientsSponsorLes Hopitaux Universitaires De Strasbourg

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.