A Multicenter, Randomized, Controlled Trial Assessing Arginine Vasopressin vs. Saline Placebo in Refractory Traumatic Hemorrhagic Shock Patients (VITRIS.at-Study) - Vasopression in Traumatic Hemorrhagic Shock Study, www.vitris.at

• Conditions: The purpose of the trial is to assess effects of arginine vasopressin vs. saline placebo on hospital admission rate and hospital discharge rate in presumed traumatic hemorrhagic shock patients after 10 min of standard shock treatment. The study reflects an add-on design to standard traumatic shock thearpy. The alternative hypothesis is that arginine vasopressin is more beneficial on hemodynamic variables etc., and hospital admission and discharge rate than saline placebo.; MedDRA version: 9.1Level: LLTClassification code 10044541Term: Traumatic shock; MedDRA version: 9.1Level: PTClassification code 10044541Term: Traumatic shock

• Registration Number: EUCTR2006-004252-20-AT
• Lead Sponsor: Medizinische Universität Innsbruck - Univ.-Klinik für Anästhesie und Allgemeine Intensivmedizin

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-03-06
• Last Update Posted: 1 December 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Inclusion criteria will be adult trauma patients presenting with presumed life-threatening traumatic hemorrhagic shock (systolic arterial blood pressure < 90 mmHg) that does not respond to the first 10 min of standard shock treatment [endotracheal intubation, crystalloid- and hypertonic saline (up to 4 ml/kg) fluid resuscitation, and catecholamine (ephedrine, phenylephrine, norepinephrine, epinephrine) vasopressors].
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

Exclusion criteria are terminal illness, no intravenous access, age <18 years, injure >60 min before randomization, known pregnancy, cardiac arrest before randomization, presence of a do-not-resuscitate order, untreated tension pneumothorax, untreated cardiac tamponade, or participation in another clinical study.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: Primary end point will be hospital admission rate.;Secondary Objective: Secondary endpoints will be hemodynamic variables, fluid resuscitaion requirements hospital discharge rate.;Primary end point(s): Primary end point will be hospital admission rate; secondary end points will be hemodynamic variables, fluid resuscitaion requirements and hospital discharge rate.