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Study on Noradrenaline and Terlipressin for Treating Septic Shock in Patients

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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 treatment of septic shock, a serious condition that occurs when an infection leads to dangerously low blood pressure and organ failure. The study involves two treatments: one group will receive noradrenaline combined with a placebo, while the other group will receive noradrenaline combined with terlipressin. Noradrenaline is a medication that helps increase blood pressure by narrowing blood vessels, and terlipressin is similar to a hormone that helps control blood pressure and reduce bleeding.

The purpose of the study is to see if adding terlipressin to noradrenaline can help reduce organ failure and increase the number of days patients can spend outside of the intensive care unit (ICU) within 28 days. Participants will be randomly assigned to one of the two treatment groups, and neither the participants nor the researchers will know which treatment each participant is receiving. This is known as a "double-blind" study, which helps ensure the results are not biased.

Throughout the study, researchers will monitor the participants' health, focusing on how well their organs are functioning and how many days they can spend without needing intensive care. The study will also look at other factors, such as the clearance of lactate (a substance that can build up in the blood during severe illness), the number of days without needing mechanical ventilation, and the overall survival rate. The study aims to provide valuable information on whether the combination of noradrenaline and terlipressin is more effective than noradrenaline alone in treating septic shock.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the patient must meet specific criteria: being 18 years or older, having septic shock, and a SOFA index greater than 4 points. The SOFA index is a score that helps assess the extent of a person's organ function or rate of failure.

    Informed consent must be signed by the patient or their legal representative. If the legal representative is not present, consent can be given by phone, with written confirmation required as soon as possible.

  2. Step 2

    Randomization and treatment assignment

    The patient will be randomly assigned to one of two groups: one receiving noradrenaline plus a placebo, and the other receiving noradrenaline plus terlipressin.

    Noradrenaline is administered as a solution for infusion, while terlipressin is given as a solution for injection.

  3. Step 3

    Treatment administration

    The treatment involves the administration of noradrenaline and either placebo or terlipressin. The specific dosage and frequency will be determined by the medical team based on the patient's condition.

    The main goal is to reduce organ failure, as evaluated by the SOFA scale, 72 hours after administration, and to increase the number of days the patient is free from intensive care unit (ICU) support within 28 days.

  4. Step 4

    Monitoring and evaluation

    The patient's response to the treatment will be closely monitored. This includes assessing organ function, lactate clearance, and the need for mechanical ventilation or renal replacement therapy.

    The study aims to increase the number of days the patient is free from vasopressors and to evaluate any potential adverse effects related to the treatment.

  5. Step 5

    Genetic analysis

    The study will also explore the association between genetic variants and the patient's response to treatment, including mortality and adverse effects.

    This involves analyzing genetic variants of the vasopressin 1a receptor and the LNPEP gene.

  6. Step 6

    Completion of the study

    The study is expected to conclude by June 30, 2025. The results will contribute to understanding the effectiveness and safety of the treatment options for septic shock.

Who can join the trial?

4 criteria

  • Adult patients who are **18 years or older**.
  • Patients who have **septic shock**.
  • Patients with a **SOFA index** greater than 4 points. The SOFA index is a score that helps doctors understand how well a patient's organs are working. If the patient is going to be put on a breathing machine (intubated) at the time of selection, the score from their medical record will be used.
  • The patient or their legal representative must sign an **informed consent** form. This is a document that explains the study and confirms that the patient agrees to participate. If the legal representative is not present, consent can be given over the phone, but a written consent must be provided as soon as possible.

Who cannot join the trial?

3 criteria

  • Patients who are not experiencing septic shock, which is a serious condition where the body has a severe response to an infection, cannot participate.
  • Patients who are not within the specified age range for the study cannot participate.
  • Patients who belong to a vulnerable population, which means they might need special protection or care, cannot participate.
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Investigated drugs

  • Noradrenaline

    is a medication used in this trial to help increase blood pressure in patients experiencing septic shock. It works by narrowing blood vessels, which helps to raise blood pressure and improve blood flow to vital organs.

  • Terlipressin

    is being tested in combination with noradrenaline to see if it can further help in reducing organ failure in patients with septic shock. It is thought to work by constricting blood vessels, which may help improve blood flow and support organ function.

What is already known about the treatment

  • Noradrenaline

    Noradrenaline is administered intravenously and is commonly used in critical care settings. It is well-established in medical literature as a first-line treatment for septic shock, helping to increase blood pressure in patients with severe infections. The medication works by stimulating alpha-adrenergic receptors, leading to vasoconstriction and increased blood pressure. It is classified as a vasopressor.

  • Terlipressin

    Terlipressin is also administered intravenously and is being studied for its potential benefits in treating septic shock. It is not as widely used as noradrenaline but is gaining attention in medical research for its ability to reduce organ failure and increase ICU-free days. Terlipressin acts by binding to vasopressin receptors, causing blood vessels to constrict and increasing blood pressure. It is classified as a vasopressin analog.

Investigated diseases

Septic Shock – Septic shock is a severe and potentially life-threatening condition that occurs when an infection leads to dangerously low blood pressure and abnormalities in cellular metabolism. It is a subset of sepsis, where the body's response to infection causes injury to its own tissues and organs. The progression of septic shock involves widespread inflammation, leading to a significant drop in blood pressure that can result in organ failure. Patients may experience symptoms such as confusion, shortness of breath, and a rapid heart rate. As the condition advances, it can lead to multiple organ dysfunction syndrome, where multiple organ systems in the body begin to fail. Early recognition and management are crucial to prevent further complications.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-514149-12-00Protocol codeCONTENTSSEstimated enrolment152 patientsSponsorFundacion Publica Andaluza Para La Gestion De La Investigacion En Salud De Sevilla

sourced from the EU Clinical Trials Register and site verification

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