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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 study about?

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.

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 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 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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
University Hospital Of Clermont-Ferrand Clermont Ferrand France
Groupe Hospitalier Du Sud Ile De France Melun France
Centre Hospitalier Regional Et Universitaire De Brest Brest France

Other Sites

Site Name City Country Status
Centre Hospitalier Victor Dupouy Argenteuil France
Hospital Foch Suresnes France
Centre Hospitalier Universitaire De Poitiers Poitiers France
Centre Hospitalier Sud Francilien Corbeil Essonnes France
Centre Hospitalier Saint Joseph Saint Luc Lyon France
Hopitaux Prives De Metz Vantoux France
Centre Hospitalier Universitaire De Nice Nice France
Grand Hopital De L Est Francilien Meaux France
Centre Hospitalier Universitaire Amiens Picardie Amiens France
Centre Hospitalier Universitaire De Rennes Rennes France
Centre Hospitalier Lyon Sud Pierre Benite France
Hopital Beaujon Clichy France
Centre Hospitalier Intercommunal De Poissy Saint Germain St Germain En Laye France
Hlrsmyf Svpem Cepejuy Bry-sur-Marne France
Cehute Hcispgszurw Rchdfurc Uwvyzxxvakvzx Dk Tafvr Tours France
Hdxievra Urcutyakklrryf Sjmdnungro &tvqwvb Hbsbrtu dl Hewhkklzzyg STRASBOURG, Alsace France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Recruiting
26.02.2021

Trial locations

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.

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 ID:
2024-515019-22-00
Protocol code:
P160925J
NCT ID:
NCT04031573
Trial Phase:
Therapeutic confirmatory (Phase III)

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