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Study on Epirubicin and Sodium Chloride for Patients with Sepsis or Septic Shock in Intensive Care Units

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What is this trial about?

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

This clinical trial is focused on studying the effects of a medication called epirubicin for patients suffering from sepsis or septic shock. Sepsis is a serious condition that occurs when the body's response to an infection causes injury to its own tissues and organs. Septic shock is a severe and potentially fatal condition that can occur as a result of sepsis, leading to dangerously low blood pressure and abnormalities in cellular metabolism. The trial aims to assess the safety of using low doses of epirubicin as an additional treatment for these conditions.

Participants in the study will receive either the medication epirubicin or a placebo. Epirubicin is administered as a solution for injection, and it is typically used in cancer treatment. In this study, it is being tested for its potential benefits in treating sepsis and septic shock. The study will also use a solution called sodium chloride, commonly known as saline, which is often used in medical settings to provide fluids and electrolytes to patients.

The purpose of the study is to determine if low-dose epirubicin is safe for patients with sepsis and septic shock. Participants will be monitored for safety, including any potential side effects, over a period of time. The study will also look at how the treatment affects organ function and overall survival rates. The trial is expected to continue until 2025, with the goal of providing valuable information on the use of epirubicin in treating these serious conditions.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Participation begins after providing written informed consent. If unable to provide consent, an authorized representative or legal representative may do so. In urgent cases, an independent consultant may confirm the necessity of participation.

  2. Step 2

    Initial assessment

    Eligibility is confirmed for patients over 18 years with sepsis or septic shock, currently hospitalized in the Intensive Care Unit (ICU) or Intermediate Care (IMC). The sepsis diagnosis must have been made within 48 hours prior to screening.

  3. Step 3

    Treatment administration

    The treatment involves the administration of epirubicin hydrochloride as a solution for injection and sodium chloride as a solution for infusion. Both are given intravenously. The specific dosage and frequency are determined by the medical team based on individual patient needs.

  4. Step 4

    Monitoring and evaluation

    Safety is assessed by monitoring for myelotoxicity until day 14. Other evaluations include the degree of organ dysfunction using the SOFA score, occurrence of adverse events, cardiotoxicity, and survival rates at days 14, 28, and 90.

    The SOFA 'Success' rate is defined by a decrease in procalcitonin (PCT) serum concentration by 80% or more of its peak value or to 0.5 µg/L or lower within 72 hours after randomization.

  5. Step 5

    Completion of trial

    The trial is estimated to end by October 19, 2025. Participation continues until the completion of the study or as determined by the medical team based on individual circumstances.

Who can join the trial?

4 criteria

  • The patient must have **sepsis** or **septic shock** and be currently hospitalized in the **Intensive Care Unit (ICU)** or **Intermediate Care (IMC)**. Sepsis is a serious condition caused by the body's response to an infection.
  • The patient must be over 18 years old.
  • The patient must have been diagnosed with sepsis within 48 hours before the screening, no matter where the infection started.
  • Written informed consent must be provided by the patient, or if the patient is unable, by an authorized representative or legal representative. If this is not possible, an independent consultant must confirm the urgency and potential benefit of participating in the trial.

Who cannot join the trial?

5 criteria

  • Patients who are not currently hospitalized in the Intensive Care Unit (ICU) or Intermediate Care (IMC).
  • Patients who do not have **sepsis** or **septic shock**. Sepsis is a serious condition where the body has a severe response to an infection, and septic shock is a severe form of sepsis that can cause dangerously low blood pressure.
  • Patients who are not within the specified age range for the study.
  • Patients who do not meet the gender requirements for the study.
  • Patients who are considered part of a vulnerable population that the study is not designed to include.
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Investigated drugs

Epirubicin is being studied as an additional treatment for patients with sepsis and septic shock. The trial aims to evaluate the safety of using low doses of this medication in combination with standard treatments for these conditions.

What is already known about the treatment

Epirubicin – Epirubicin is administered intravenously, typically in a hospital setting. It is currently being studied as an adjunctive therapy for patients with sepsis and septic shock, particularly in intensive care units. The main therapeutic indication in this trial is to evaluate its safety in treating these severe infections. At the molecular level, epirubicin works by intercalating DNA strands, which inhibits the synthesis of nucleic acids, leading to cell death. It is classified pharmacologically as an anthracycline antibiotic, commonly used in cancer treatment, but now being explored for its potential benefits in critical care settings.

Investigated diseases

Sepsis – Sepsis is a severe medical condition that occurs when the body's response to an infection causes widespread inflammation. This inflammation can lead to tissue damage, organ failure, and other serious complications. It typically begins with an infection in one part of the body, such as the lungs, urinary tract, or skin, and can spread through the bloodstream. As the condition progresses, it can cause a drop in blood pressure, leading to septic shock, which is a more severe form of sepsis. Septic shock is characterized by a significant decrease in blood flow, which can result in multiple organ dysfunction. Early recognition and management are crucial to prevent further complications.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-515776-12-00Protocol codeEPOS_ZKSJ0134Estimated enrolment45 patientsSponsorFriedrich-Schiller-Universitaet Jena

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