A Multicenter, Randomized, Controlled Trial Assessing Arginine Vasopressin vs. Saline Placebo in Refractory Traumatic Hemorrhagic Shock Patients (VITRIS.at-Study).Eine multizentrische, randomisierte, kontrollierte klinische Studie zur Untersuchung von Arginin-Vasopressin vs. Kochsalz-Placebo bei Patienten mit lebensbedrohlichem Blutungsschock nach einem Trauma (VITRIS.at Studie). - Vasopression in Traumatic Hemorrhagic Shock Study (VITRIS.at Study)

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 life-threatening 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: 14.1Level: PTClassification code 10044541Term: Traumatic shockSystem Organ Class: 10022117 - Injury, poisoning and procedural complications

Registration Number: EUCTR2006-004252-20-DE

Lead Sponsor: Medizinische Universität Innsbruck - Univ.-Klinik f. Anästhesie u. Intensivmedizin

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 200

Inclusion Criteria

- adult trauma patients age >=18 years

- presumed traumatic hemorrhagic shock (systolic arterial blood pressure < 90 mmHg)

- shock 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]

- randomization time: 10 minutes after arrival of first emergency physician until 30 minutes after arrival of first emergency physician
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

- 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 (DNR) order

- untreated tension pneumothorax

- untreated cardiac tamponade

- participation in another clinical study.