Study on Adding Vasopressin to Treat Patients with Septic Shock

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What is this study about?

This clinical trial is focused on studying the effects of adding a medication called vasopressin to the treatment of patients experiencing a severe condition known as septic shock. Septic shock is a serious medical condition that occurs when an infection leads to dangerously low blood pressure and organ failure. The study aims to understand how the addition of vasopressin affects organ function in these patients.

In this study, participants will receive either vasopressin or a placebo in addition to their standard treatment, which includes a medication called noradrenaline. Noradrenaline is commonly used to help maintain blood pressure in patients with septic shock. The study will compare the effects of vasopressin with those of a placebo to see if there is a difference in how well the organs function after treatment. The treatment will be administered through an intravenous infusion, which means it will be given directly into the bloodstream over a period of time.

The study will last for a maximum of five days, during which the health of the participants will be closely monitored. Researchers will look at various health indicators, such as changes in organ function and overall survival rates, to determine the effectiveness of the treatment. The goal is to gather information that could lead to improved treatment options for patients with septic shock in the future.

1 joining the study

Upon joining the study, you will be informed about the purpose and procedures involved. You will need to provide consent to participate, or a close relative may do so on your behalf if necessary.

2 initial assessment

An initial assessment will be conducted to confirm your eligibility. This includes verifying that you are 18 years or older and experiencing septic shock with specific medical criteria.

3 randomization

You will be randomly assigned to one of two groups. This process is double-blind, meaning neither you nor the medical staff will know which group you are in.

4 medication administration

You will receive an intravenous infusion of either argipressin or a placebo. The infusion will be administered through a vein, and the dosage will be determined by the study protocol.

5 monitoring and follow-up

Your health will be closely monitored for changes in your condition. This includes measuring the SOFA score at 48 hours and at day 5, as well as other health indicators over a 28-day period.

Regular assessments will be conducted to track your progress and any side effects. This includes monitoring for any changes in heart function, blood flow, and other vital signs.

6 end of participation

Your participation in the study will conclude after the 28-day monitoring period. The results will contribute to understanding the effects of the medication on septic shock.

Who Can Join the Study?

Patient must be 18 years of age or older.
Patient must have consented to participate in the research, or a close relative must have consented, or the patient is included in an emergency situation.
Patient must be in septic shock with the following conditions:
- A proven or suspected infection that requires antibiotic treatment.
- Lactatemia (a measure of lactic acid in the blood) greater than 2.0 mmol/L.
- Receiving a noradrenaline dosage greater than 0.3 µg/kg/min for more than one hour to keep blood pressure above 65 mmHg, despite fluid treatment.
- Adequate heart function, shown by a cardiac index (a measure of heart output) of 3.0 L/min/m² or more, or central venous oxygen saturation (ScvO2) of 70% or more.
Patient’s noradrenaline dosage must have been greater than 0.3 µg/kg/min for less than 12 hours at the time of joining the study.
Patient must be benefiting from or affiliated with a social security system.

Who Cannot Join the Study?

Patients who are not experiencing septic shock cannot participate. Septic shock is a serious condition that happens 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. The study is designed for specific groups 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. The study includes individuals who may need special protection or care.

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name	City	Country
Centre Hospitalier Universitaire De Nimes	Nimes	France
Centre Hospitalier Du Pays D Aix Centre Hospitalier Intercommunal Aix-Pertuis	Aix En Provence	France
Arcvibnveu Pehhtcjy Hrluforq Dm Mrgpriinh	Marseille	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	01.03.2025

Trial locations

Investigated drugs:

Vasopressin is a medication used in this clinical trial to help manage septic shock, a serious condition that occurs when an infection leads to dangerously low blood pressure and organ failure. Vasopressin works by narrowing blood vessels, which helps to increase blood pressure and improve blood flow to vital organs. In this study, the researchers are investigating whether adding vasopressin to the treatment of patients with a specific type of septic shock, known as hyperkinetic septic shock, can help reduce organ failure and improve patient outcomes.

Investigated diseases:

Septic shock

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 leak, leading to a drop in blood pressure. As the condition progresses, organs may start to fail due to inadequate blood flow and oxygen delivery. The body attempts to compensate by increasing heart rate and constricting blood vessels, but these efforts may not be sufficient. If untreated, the condition can lead to multiple organ dysfunction. The progression of septic shock can be rapid, requiring immediate medical attention to stabilize the patient.

Trial ID:

2024-513401-31-00

Protocol code:

RCAPHM23_0465

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Adding Vasopressin to Treat Patients with Septic Shock

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?