Study on Early Use of Vasopressin and Norepinephrine for Patients with Septic Shock

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What is this study about?

This clinical trial is focused on studying the effects of early treatment with a medication called vasopressin in patients experiencing septic shock. Septic shock is a severe condition that occurs when an infection leads to dangerously low blood pressure and organ failure. The study aims to determine if starting vasopressin earlier, alongside another medication called norepinephrine, can improve kidney function in these patients during their first week in the Intensive Care Unit (ICU).

Participants in the study will receive either vasopressin and norepinephrine together or norepinephrine alone initially, with vasopressin added later if needed. The study will monitor how these treatments affect the need for kidney support, such as dialysis, and other health outcomes. The medications used in this study include SonoVue, which contains sulfur hexafluoride, and Empressin, which contains argipressin. These medications are administered intravenously, meaning they are given directly into a vein.

The study will also look at other factors, such as how well blood flows to the kidneys, the balance of fluids in the body, and any side effects like heart rhythm problems or reduced blood flow to the intestines or limbs. The goal is to see if early use of vasopressin can lead to better outcomes for patients with septic shock, including shorter stays in the ICU and improved survival rates. The study is expected to continue until March 2026.

1 enrollment

Upon joining the study, the patient must be diagnosed with septic shock and hospitalized in an intensive care setting within 24 hours of diagnosis.

The patient must be able to provide informed consent and be between 18 and 80 years old.

The patient must have a norepinephrine dosage of at least 0.25 micrograms per kilogram per minute based on their ideal body weight.

2 initial treatment

The patient will receive vasopressin and norepinephrine intravenously. The timing of vasopressin administration is crucial and will be determined by the study protocol.

3 monitoring and evaluation

The patient’s renal function will be monitored to assess the need for renal replacement therapy within the first 7 days of ICU admission.

Renal perfusion will be evaluated using the CEUS method within 24 hours of enrollment and again 72 hours after the first evaluation. This involves checking for ischemic areas in the kidneys.

4 ongoing assessments

Water balance will be measured at 24, 48, and 72 hours after ICU admission.

The occurrence of any heart rhythm issues, such as atrial flutter or other arrhythmias, will be monitored. If these occur, additional treatments may be required.

5 final evaluations

The length of stay in the ICU and mortality rates at 28 and 90 days will be recorded.

The study aims to achieve a 30% reduction in patients needing continuous renal replacement therapy (CRRT) and to reduce the severity of kidney injury as classified by the KDIGO system.

Who Can Join the Study?

Patients must have a condition called septic shock, which is a serious infection that affects the whole body.
Patients need to be in a hospital’s intensive care unit within 24 hours after being diagnosed with septic shock.
Patients must be able to understand and agree to the treatment, which means they can give informed consent.
Patients should be between 18 and 80 years old.
Both men and women can participate.
Patients must be receiving a medication called norepinephrine at a dosage of 0.25 micrograms per kilogram per minute or more, based on their ideal body weight.

Who Cannot Join the Study?

Patients who are not experiencing septic shock. 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 for the study.
Patients who belong to a clinical trial group that is not included in this study.
Patients who are part of a vulnerable population, which means they might need special protection or care.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Azienda Unita Sanitaria Locale Di Bologna	Bologna	Italy

Trial status

Country	Status	Recruitment Start
Italy	Recruiting	01.03.2024

Trial locations

Investigated drugs:

Vasopressin is a medication used to help manage blood pressure in patients experiencing septic shock. In this trial, it is being studied to see if using it earlier can affect the need for kidney support treatments in patients during their first week in the Intensive Care Unit.

Norepinephrine is another medication used to increase blood pressure in patients with septic shock. The trial is examining how combining norepinephrine with vasopressin at different times might impact kidney function and the need for additional treatments.

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 occurs when an infection in the body triggers an extreme immune response, causing inflammation and blood clotting throughout the body. This can result in reduced blood flow to vital organs, leading to organ dysfunction. As the condition progresses, patients may experience symptoms such as confusion, rapid heart rate, and difficulty breathing. The body’s inability to maintain adequate blood pressure can lead to further complications. Without timely intervention, the condition can worsen, affecting multiple organ systems.

Trial ID:

2023-509071-16-00

Protocol code:

EVSS

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Early Use of Vasopressin and Norepinephrine for Patients with Septic Shock

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?