Terlipressin in the treatment of catecholamine-resistant septic shock - Terlipressin in septic shock

Phase 1

• Conditions: Septic shock refractory to standard dose of norepinephrine; MedDRA version: 9.1Level: LLTClassification code 10040070Term: Septic shock

• Registration Number: EUCTR2007-000513-12-CZ
• Lead Sponsor: Úrazová nemocnice brno

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-02-08
• Last Update Posted: 21 August 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Age >18 years
Male or non-pregnant female
Refractory septic shock (norepinehprine 0.3 microg/kg/min) with hemodynamic instability (MAP<60 mm Hg)
Proven or suspected bacterial infection
Informed consent in accordance with Act 129/2003, §34, sect. 8 or 3d and GCP E6, sect. 4.8.15)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Pregnancy
Known hypersensitivity to terlipressine
Acute coronary artery disease
Vasospastic diathesis
Acute mesenteric ischemia
Epilepsy

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The trial is designed to evaluate the hemodynamic effects of terlipressin in septic shock patients refractory to standard high dose of norepinephrine.;Secondary Objective: To assess ventilated days, ICU days, and 30 days mortality in patients treated with terlipressin. ;Primary end point(s): We will test the statistical null hypothesis that there is no difference in hemodynamic parameters in those receiving terlipressine compared with those receiving standard treatment (norepinephrine).