EUCTR2006-004252-20-DE
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).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)
Medizinische Universität Innsbruck - Univ.-Klinik f. Anästhesie u. Intensivmedizin0 个研究点目标入组 200 人2008年5月28日
适应症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
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- 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.
- 发起方
- Medizinische Universität Innsbruck - Univ.-Klinik f. Anästhesie u. Intensivmedizin
- 入组人数
- 200
- 状态
- 进行中（未招募）
- 最后更新
- 11年前
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •\- 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
排除标准
- •\- 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.
结局指标
主要结局
未指定
相似试验
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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.atThe 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 shockEUCTR2006-004252-20-ATMedizinische Universität Innsbruck - Univ.-Klinik für Anästhesie und Allgemeine Intensivmedizin200
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