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Noradrenaline plus placebo vs noradrenaline plus terlipressin for the treatment of septic shock
EU CTIS ID: 2024-514149-12-00
What this study is testing
Main objective is composed by: -Reduction of organ failure evaluated by Sepsis realted Organ failure Assessment score (SOFA scale) 72 h after administration of terlipressin / placebo. -Increase in ICU-free days of life measured 28 days after administration of terlipressin / placebo
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Adult patients (18 years or older).
- Patients with septic shock.
- Patients with a SOFA index> 4 points. (If the patient is going to be intubated at the time of randomization, take the neurological SOFA score from the medical record)
- Signature of the informed consent by the patient or his or her legal representative. (Informed consent may be granted by phone if the legal representative is not present at the center at the time of signing, with written re-consent required as soon as possible)
You likely can't join if
- Pregnant or lactating patients
- Previous use of terlipressin during your stay in the ICU
- Previous use of vasopressin.
- Known allergy to terlipressin
- Pathologies on which terlipressin is clinically indicated: gastrointestinal bleeding due to esophageal-gastric varices, hepatorenal syndrome.
- Patients diagnosed with unstable acute coronary syndrome.
See the full eligibility criteria
- Adult patients (18 years or older).
- Patients with septic shock.
- Patients with a SOFA index> 4 points. (If the patient is going to be intubated at the time of randomization, take the neurological SOFA score from the medical record)
- Signature of the informed consent by the patient or his or her legal representative. (Informed consent may be granted by phone if the legal representative is not present at the center at the time of signing, with written re-consent required as soon as possible)
- Pregnant or lactating patients
- Previous use of terlipressin during your stay in the ICU
- Previous use of vasopressin.
- Known allergy to terlipressin
- Pathologies on which terlipressin is clinically indicated: gastrointestinal bleeding due to esophageal-gastric varices, hepatorenal syndrome.
- Patients diagnosed with unstable acute coronary syndrome.
- Patients with acute or chronic mesenteric ischemia
- Patients with Raynaud's Phenomenon, or vasospastic disease.
- Patients participating in another intervention clinical trial.
- Patients with active bleeding.
- Patients with renal replacement technique at the time of randomization.
- Patients with some limitation of life support treatment (LLST).
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.