Study on Noradrenaline and Terlipressin for Treating Septic Shock in Patients

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What is this study about?

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.

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 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 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 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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Hospital Jerez de la Frontera Jerez De La Frontera Spain

Other Sites

Site Name City Country Status
Hospital Universitario Puerta Del Mar Cadiz Spain
Hospital Universitario De Jaen Jaen Spain
Hospital Universitario Virgen De Las Nieves Granada Spain

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

Trial status

Country Status Recruitment Start
Spain Spain
Not recruiting
01.02.2022

Trial locations

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.

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 ID:
2024-514149-12-00
Protocol code:
CONTENTSS
NCT ID:
NCT05207280
Trial Phase:
Therapeutic confirmatory (Phase III)

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