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Study on Ivabradine for Heart Rate Control and Survival in Adults with Septic Shock

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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 ivabradine on patients experiencing septic shock. Septic shock is a serious condition that occurs when an infection leads to dangerously low blood pressure, which does not improve with fluid treatment and requires medication to maintain adequate blood pressure. The trial aims to see if ivabradine can help control heart rate and improve survival over a 28-day period for these patients.

Participants in the study will receive either ivabradine or a placebo, which looks like the real medication but does not contain any active ingredients. The study will be conducted in two stages. The first stage will focus on how well ivabradine controls heart rate, while the second stage will assess its impact on survival rates. The trial will also look at how well patients tolerate ivabradine and its effects on heart function, organ health, and overall recovery in intensive care.

The study will last for a period of time, during which participants will be monitored closely to track their heart rate and overall health. The goal is to determine if ivabradine can be an effective treatment for managing heart rate and improving outcomes in patients with septic shock. This research could provide valuable insights into better treatment options for this serious condition.

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 trial

    Upon joining the clinical trial, you will be required to provide informed consent. This means you agree to participate after understanding the trial's purpose, procedures, and potential risks.

    You must be at least 18 years old, have a proven or suspected site of infection, and be experiencing septic shock. Your heart rate should be 95 beats per minute or higher at the time of joining.

  2. Step 2

    Randomization

    You will be randomly assigned to one of the study groups. This process ensures that each participant has an equal chance of receiving either the Procoralan 5 mg film-coated tablets or a placebo (a tablet with no active medication).

  3. Step 3

    Medication administration

    If you are assigned to the group receiving the active medication, you will take Procoralan 5 mg tablets. The medication is administered through an enteral feeding tube.

    The dosage and frequency of the medication will be determined by the study team based on your specific needs and the trial protocol.

  4. Step 4

    Monitoring and assessments

    Your heart rate will be closely monitored to ensure it falls within the predefined threshold of 80-94 beats per minute by hour 48 of the trial.

    Additional assessments will be conducted to evaluate the impact of the medication on your overall health, including heart function and any potential side effects.

  5. Step 5

    Follow-up and final analysis

    The trial will continue for a period of 28 days, during which your health and response to the medication will be regularly evaluated.

    The final analysis will focus on your survival rate at the end of the 28-day period and any changes in your heart rate and overall health.

Who can join the trial?

6 criteria

  • Must be 18 years of age or older.
  • Must have a proven or suspected site of infection.
  • Must have septic shock, which means low blood pressure that doesn't improve with fluids and needs medication to maintain adequate blood pressure, for at least 2 hours and less than 24 hours. If medication doses are increasing, inclusion is possible before 2 hours.
  • Must have a heart rate of 95 beats per minute or higher at the time of joining the study. Heart rate is the number of times your heart beats in one minute.
  • Must provide informed consent, which means agreeing to participate after understanding the study details, according to local rules.
  • Must be affiliated with a social security regime, meaning you should be part of a system that provides health insurance or benefits.

Who cannot join the trial?

5 criteria

  • Patients who are not experiencing septic shock cannot participate. Septic shock is a serious condition that occurs when an infection leads to dangerously low blood pressure.
  • Patients who are not within the specified age range cannot participate. The study is open to certain age groups only.
  • Patients who are not part of the specified clinical trial groups cannot participate. This means the study is looking for specific types of patients.
  • Patients who are not male or female cannot participate. The study includes both male and female participants.
  • Patients who are not considered part of a vulnerable population cannot participate. A vulnerable population includes groups that may need special protection.
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Investigated drugs

Ivabradine is a medication used in this clinical trial to help control the heart rate of patients. It works by slowing down the heart rate, which can be beneficial for patients experiencing septic shock. The goal is to see if controlling the heart rate with ivabradine can improve the chances of survival over a 28-day period. This trial is conducted in two stages: the first stage focuses on how well ivabradine can control heart rate, and the second stage looks at whether it can help reduce mortality in patients.

What is already known about the treatment

Ivabradine – Ivabradine is administered orally in the form of tablets and is currently being studied in clinical trials for its potential benefits in treating septic shock. It is primarily used to control heart rate and improve survival rates in patients with this condition. Ivabradine works by selectively inhibiting the funny current (If) in the sinoatrial node of the heart, which reduces heart rate without affecting blood pressure. It is classified as a heart rate-reducing agent and is being evaluated for its effectiveness in improving outcomes in septic shock patients.

Investigated diseases

Septic shock – Septic shock is a severe and widespread infection that leads to dangerously low blood pressure and abnormalities in cellular metabolism. It begins with an infection that triggers a systemic inflammatory response, causing blood vessels to dilate and blood pressure to drop. As the condition progresses, organs may not receive enough oxygen and nutrients, leading to organ dysfunction. The body attempts to compensate by increasing heart rate and constricting blood vessels, but these measures can eventually fail. If not managed, the lack of adequate blood flow can cause multiple organ systems to fail. The progression of septic shock can be rapid, requiring immediate medical attention to stabilize the patient.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-515019-22-00Protocol codeP160925JEstimated enrolment429 patientsSponsorAssistance Publique Hopitaux De Paris

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