EUCTR2006-004252-20-AT进行中（未招募）不适用
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 个研究点目标入组 200 人开始时间: 2008年3月6日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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.
研究者
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进行中（未招募）
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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)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 complicationsEUCTR2006-004252-20-DEMedizinische Universität Innsbruck - Univ.-Klinik f. Anästhesie u. Intensivmedizin200
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