drugset / Trial / NCT00379522

Vasopressin in Traumatic Hemorrhagic Shock Study

NCT00379522

Phase 2/3 Completed 64 enrolled Volker Wenzel
RandomizedSingle-groupDouble-blindTreatment

Summary

The purpose of the present trial is therefore to assess effects of arginine vasopressin vs. saline placebo on hospital admission rate (primary end point), as well as hemodynamic variables, fluid resuscitation requirements and hospital discharge rate (secondary study end points) in presumed traumatic hemorrhagic shock patients with a systolic arterial blood pressure \<90 mm Hg after 10 min of standard shock treatment. Accordingly, the study reflects an add-on design to standard traumatic shock therapy. The hypothesis is that both arginine vasopressin and saline placebo have comparable effects on hemodynamic variables, fluid resuscitation requirements, and hospital admission and discharge rate. The alternative hypothesis is that arginine vasopressin has more beneficial effects on hemodynamic variables, fluid resuscitation requirements, and hospital admission and discharge rate than saline placebo.

Timeline

Start
2010-07
Primary completion
2014-10
Completion
2014-10

Publications

Drugs

EvaluationDrugModalityDoseRoute
Comparator Vasopressin Peptide 10 iu Intravenous

Indications

No indication recorded.