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Study on Early Use of Vasopressin and Norepinephrine for Patients 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 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.

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

    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. Step 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. Step 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. Step 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. Step 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 trial?

6 criteria

  • 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 trial?

4 criteria

  • 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.
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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.

What is already known about the treatment

  • Vasopressin

    Vasopressin is administered intravenously and is used in the treatment of septic shock. It is currently being studied in clinical trials to assess its effectiveness in improving renal outcomes when used early in combination with norepinephrine. The main therapeutic indication for vasopressin is to support blood pressure in patients experiencing septic shock. At the molecular level, vasopressin works by binding to V1 receptors on blood vessels, causing them to constrict and thereby increasing blood pressure. It is classified as a vasopressor, which is a type of medication that raises blood pressure.

  • Norepinephrine

    Norepinephrine is also administered intravenously and is commonly used in the management of septic shock. It is a well-established medication in medical practice and literature, often used to maintain blood pressure in critically ill patients. The primary therapeutic indication for norepinephrine is to treat low blood pressure, particularly in septic shock. Its mechanism of action involves stimulating alpha-adrenergic receptors, leading to vasoconstriction and increased blood pressure. Norepinephrine is classified as a vasopressor, similar to vasopressin, and is a key medication in critical care settings.

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 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 detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-509071-16-00Protocol codeEVSSEstimated enrolment242 patientsSponsorAzienda Unita Sanitaria Locale Di Bologna

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