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oradrenaline plus placebo vs noradrenaline plus terlipressin for thetreatment of septic shock

Phase 1
Conditions
Septic Shock
MedDRA version: 20.0Level: LLTClassification code: 10040089Term: Septicemia Class: 10021881
MedDRA version: 23.1Level: PTClassification code: 10040070Term: Septic shock Class: 100000004862
Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
Registration Number
CTIS2024-514149-12-00
Lead Sponsor
Fundacion Publica Andaluza Para La Gestion De La Investigacion En Salud De Sevilla
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Recruiting
Sex
All
Target Recruitment
152
Inclusion 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)

Exclusion Criteria

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).

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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