Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not recruiting

Study of hydrocortisone and fludrocortisone combination versus placebo in adults with sepsis in intensive care unit to determine corticosteroid response

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

This study focuses on patients with sepsis, a serious condition that occurs when the body's response to infection causes injury to its own tissues. The research aims to determine which patients with sepsis would benefit most from treatment with corticosteroid medications. The study will test two medications: hydrocortisone combined with fludrocortisone, comparing them against placebo in patients who are being treated in the intensive care unit due to suspected or proven infection.

The medications being studied belong to a group of drugs called corticosteroids, which help reduce inflammation in the body. Hydrocortisone hemisuccinate is given through a vein, while fludrocortisone is taken as a tablet. Some patients will receive the actual medications, while others will receive placebo versions that look the same but contain no active ingredients.

The study will track how patients respond to treatment over 90 days, focusing on their survival and recovery from organ problems. Specifically, the researchers will monitor whether patients still need breathing machines, blood pressure medications, or kidney support. The study will also follow patients' progress for up to 6 months after starting treatment to understand the long-term effects of these medications.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial treatment phase

    After joining the study, you will receive either hydrocortisone and fludrocortisone medications or their placebo alternatives

    The medications will be given in two ways: hydrocortisone through an intravenous line (directly into your vein), and fludrocortisone as oral tablets

    Your treatment will be determined randomly, and neither you nor your healthcare providers will know which treatment you are receiving

  2. Step 2

    Monitoring period in intensive care

    Your condition will be closely monitored in the intensive care unit (ICU)

    The medical team will track your need for breathing support through a ventilator

    Your blood pressure will be monitored, along with any need for medications to maintain it

    Your organ function will be regularly assessed using medical tests

  3. Step 3

    90-day follow-up

    Your health status will be evaluated at days 7, 14, 28, and 90

    The medical team will record how many days you spend without needing breathing support or blood pressure medications

    Your organ function will continue to be monitored

  4. Step 4

    6-month assessment

    A final health evaluation will occur at 6 months after starting the study

    You will complete a quality of life questionnaire called EuroQol-5D

    The medical team will record if you needed any additional ICU stays during the study period

Who can join the trial?

12 criteria

  • Must be at least 18 years old
  • Must be admitted to the Intensive Care Unit (ICU) with confirmed or suspected infection as the main diagnosis
  • Must have one of the following conditions:
    • Community-acquired pneumonia related sepsis (severe infection affecting the whole body), or
    • Need for medications to maintain blood pressure (such as norepinephrine), or
    • Septic shock (severe condition requiring medications to maintain blood pressure and having high blood lactate levels), or
    • Acute respiratory distress syndrome (ARDS) - a severe breathing condition with lung inflammation and fluid buildup
    • Must be able to provide written informed consent, or have a representative who can provide consent if the patient is unable to do so
    • Must have been tested for at least one of the study's specific biological markers
    • Must have health insurance coverage
    • Can participate if under legal guardianship or curatorship
    • Can participate in emergency situations when legally permitted
    • Must have COVID-19 and available biological samples

Who cannot join the trial?

12 criteria

  • Age below 18 years or above 89 years
  • Pregnancy or breastfeeding women
  • Known allergic reaction to hydrocortisone or fludrocortisone (medications used in the study)
  • Patients who already receive systemic corticosteroids (a type of anti-inflammatory medication)
  • Presence of a medical condition that, in the opinion of the study doctor, would make it unsafe to participate
  • Participation in another clinical trial within the past 30 days
  • Patients with terminal illness (a condition that cannot be cured and is likely to lead to death)
  • Patients unable to provide informed consent and without a legal representative
  • Patients with severe immunosuppression (weakened immune system)
  • Recent major surgery within the past 7 days
  • Patients with active bleeding or high risk of bleeding
  • Patients with severe 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 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

Hydrocortisone is a steroid medication that helps reduce inflammation in the body and suppresses the immune system. It is commonly used to treat severe inflammatory conditions and helps manage sepsis (a serious blood infection) by controlling the body's inflammatory response. Fludrocortisone is a synthetic steroid medication that works similarly to natural hormones produced by the adrenal glands. It helps regulate salt and water balance in the body and is often used alongside other steroids to help maintain proper blood pressure and mineral balance, particularly in critically ill patients. The trial compares these medications combined versus a placebo in patients with sepsis who are in intensive care units, focusing on how different patients respond to steroid treatment based on their individual immune responses.

What is already known about the treatment

  • Hydrocortisone

    A synthetic corticosteroid medication administered intravenously or orally that is widely used in intensive care settings for treating severe infections and sepsis. It works by suppressing excessive inflammatory responses and supporting blood pressure maintenance, while its mechanism of action involves binding to glucocorticoid receptors to regulate gene expression affecting inflammation and immune responses. This medication belongs to the glucocorticoid class of drugs and is considered a standard treatment option in critical care medicine for patients with septic shock.

  • Fludrocortisone

    A synthetic mineralocorticoid medication typically administered orally that works alongside hydrocortisone in critical care settings to help maintain blood pressure and electrolyte balance. It acts primarily by increasing sodium retention and potassium excretion in the kidneys, with its mechanism of action involving binding to mineralocorticoid receptors to regulate fluid and electrolyte homeostasis. This medication belongs to the mineralocorticoid class of drugs and is often used in combination therapy for treating severe infections and septic shock.

Investigated diseases

  • Sepsis

    A serious condition that occurs when the body's response to infection causes injury to its own tissues and organs. It develops when the chemicals released into the bloodstream to fight an infection trigger widespread inflammatory responses throughout the body. This condition can lead to changes in body temperature, heart rate, breathing, and organ function. The body's organs begin to work poorly as sepsis progresses, potentially causing alterations in mental status, breathing difficulties, and reduced urine output. Without proper immune system response, sepsis can progress to affect multiple organ systems.

  • Acute Respiratory Failure

    A condition where the respiratory system fails in one or both of its gas exchange functions: oxygenation and carbon dioxide elimination. It develops when the respiratory system cannot maintain adequate oxygen levels in the blood or remove enough carbon dioxide from it. The condition can develop rapidly or gradually, causing shortness of breath, rapid breathing, and air hunger. It often requires mechanical support to help with breathing.

  • Shock

    A critical condition where the body's organs and tissues don't receive adequate blood flow and oxygen. The condition causes blood pressure to drop significantly, leading to weakness, confusion, and organ dysfunction. As shock progresses, it can affect multiple body systems, causing various symptoms including rapid breathing, weak pulse, and cold, clammy skin.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-516407-16-00Protocol codeAPHP191110Estimated enrolment1 800 patientsSponsorAssistance Publique Hopitaux De Paris

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.