EUCTR2006-004252-20-AT
Active, not recruiting
Not Applicable
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
Medizinische Universität Innsbruck - Univ.-Klinik für Anästhesie und Allgemeine Intensivmedizin0 sites200 target enrollmentMarch 6, 2008
ConditionsThe 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 shockMedDRA version: 9.1Level: PTClassification code 10044541Term: Traumatic shock
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- 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.
- Sponsor
- Medizinische Universität Innsbruck - Univ.-Klinik für Anästhesie und Allgemeine Intensivmedizin
- Enrollment
- 200
- Status
- Active, not recruiting
- Last Updated
- 11 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Not specified
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