Randomized Clinical Trial Comparing Noradrenaline Plus Placebo Versus Terlipressin Plus Noradrenaline for the Treatment of Septic Shock

NCT05207280 Phase 3 UNKNOWN

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.

Details

Lead sponsor	Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Phase	Phase 3
Status	UNKNOWN
Enrolment	152
Start date	2022-10-11
Completion	2024-11

Conditions

• Septic Shock

Interventions

• Noradrenaline plus Terlipressin

Primary outcomes

• Organ failure — 72 hours
  Number of organ failures related sepsis. Assessment Sepsis related Organ Failure Assessmen scale (SOFA scale) after administration of terlipressin / placebo. These scale assesses organ dysfunction. In patients with infection, a SOFA score ≥ 2 points (in patients with chronic organ dysfunction, a 2 point increase from baseline score) is diagnostic of sepsis.
• Days of life free of stay in the Intensive Care Unit — 28 days
  Number of the days of life free of stay in the Intensive Care Unit measured after the administration of terlipressin / placebo

Countries

Spain