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: 9.1 Le
Conditions
Interventions
Product Name: Arginin-Vasopressin
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Vasopressin
CAS Number: 113-79-1
Current Sponsor code: Vitiris
Concentration unit: IU international u
Sponsors
Medizinische Universität Innsbruck - Univ.-Klinik für Anästhesie und Allgemeine Intensivmedizin
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria will be adult trauma patients presenting with presumed life-threatening traumatic hemorrhagic shock (systolic arterial blood pressure =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Exclusion criteria are terminal illness, no intravenous access, age 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Austria, Germany
Outcome results
None listed