drugset / Trial / NCT05207280

Clinical Trial Comparing Noradrenaline (NA) Plus Placebo Versus Noradrenaline Plus Terlipressin (TP) in Septic Shock

NCT05207280

RandomizedParallel-groupDouble-blindTreatment

Summary

Septic shock is a major health problem. In the clinical practice guidelines of the Surviving Sepsis Campaign is recommended to add vasopressin (VP) or epinephrine in case of not reaching the goal of mean arterial pressure (MAP) although with a low level of evidence. This is a clinical trial with the purpose of comparing the efficacy and safety of norepinephrine (NE) plus placebo versus NE plus terlipressin (TP) in adult patients with septic shock and with a Sepsis related Organ Failure Assessment score (SOFA)\> 4 points. The primary objective will be a combined end-point: reduction of organic dysfunction measured at 72 h by SOFA score and by the increase in ICU (Intensive care unit) -free days measured at 28 days.

Timeline

Start
2022-10-11
Primary completion
2024-11
Completion
2024-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Terlipressin Peptide 1 mg Intravenous
Background Noradrenaline Unknown 0.2 ug/kg Intravenous