Trial intelligence / Profile preview

Terlipressin Versus Placebo for Septic Shock Refractory to High Doses Catecholamine Vasopressors

NCT04339868Phase 2

Key facts

Status
Unknown
Start
Apr 2020
Primary completion
Mar 2025
Countries
1
Sponsor
Mahidol University
Modality
Peptides, Small Molecules
Conditions
septic shock
01

Overview

Phase 2, randomised, double-blind trial in septic shock comparing Terlipressin group with Placebo group (2 arms). Primary endpoint: Achieve target blood pressure with low dose adrenergic agents at 6 hours. Status: unknown.

02

Design

2 arms
Study design
RandomizedDouble-blind
  • Terlipressin group

    Terlipressin acetate 20-100 mcg/hr plus standard of care (norepinephrine/epinephrine)

  • Placebo group

    Placebo (0.9% NaCl) plus standard of care (norepinephrine/epinephrine)

03

Who it enrols

Patients with septic shock refractory to high-dose norepinephrine (>= 0.2 mcg/kg/min) or norepinephrine plus epinephrine, with MAP < 65 mmHg or lactate > 2 mmol/L, excluding those with severe cardiac conditions, end-stage renal or liver disease, or refractory malignancies.

04

Endpoints

Primary

  • Achieve target blood pressure with low dose adrenergic agents

Secondary

  • 28 day mortality

  • Mean arterial blood pressure

  • Hospital mortality

  • ICU mortality

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