Vasopressin in Traumatic Hemorrhagic Shock Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00379522
Recruitment Status : Completed
First Posted : September 22, 2006
Last Update Posted : November 5, 2014
Information provided by (Responsible Party):
Volker Wenzel, Medical University Innsbruck

Brief 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.

Condition or disease Intervention/treatment Phase
Shock Hypovolemia Hemorrhagic Shock Drug: Vasopressin Drug: Saline placebo Phase 2 Phase 3

Detailed Description:

The study will be designed as a multicenter, randomized, placebo-controlled clinical trial with blinded assessment of the outcome in a study network with helicopter emergency medical service units in Austria, Germany, Switzerland, Italy, Czech Republic and the Netherlands.

The protocol, information and consent procedure will be approved by the institutional review board of each participating center. Since this is a study randomizing unconscious patients who are unable to give informed consent at the time of randomization (§43a Emergency study), the requirement of informed consent is planned to be waived in accordance with the ethical standards of national legislation in Germany, Austria, Switzerland, Italy, Czech Republic and the Netherlands and the guidelines for good clinical practice of the European Agency for the Evaluation of Medicinal products. Depending on the patient's outcome, either the surviving patient, or the patient's family in case of death of the patient or in case that the patient survives but remains mentally handicapped will be informed about the trial (see appendix for patient information sheet); the protocol specifies that if there are any objections, the patient will be withdrawn from the study.

Treatment assignments of blinded study drugs will be randomly generated by computer in blocks of two, with stratification according to center. Before the start of the trial, staff at participating centers will be informed about the rationale of the protocol and the study; participating centers will be subsequently contacted and visited to ensure proper enrollment.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Controlled Trial Assessing Arginine Vasopressin Versus Saline Placebo in Refractory Traumatic Hemorrhagic Shock Patients (VITRIS-study)
Study Start Date : July 2010
Primary Completion Date : October 2014
Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Vasopressin
Vasopressin, 10 I.U./4 ml, Solution for Injection
Drug: Vasopressin
10 minutes after standard shock treatment 10 IU arginine vasopressin will be injected; if shock persists for 5 minutes, another 10 IU arginine vasopressin will be injected; after 5 minutes persisting shock, the last 10 IU arginine vasopressin will be injected; Total duration: approx. 15 minutes; Dose per intravenous injection: 10 IU; max. dose: 30 IU arginine vasopressin
Other Names:
  • Pressyn
  • CPREssin
  • Pitressin
Placebo Comparator: Saline
Saline placebo 4 ml, Solution for Injection
Drug: Saline placebo
Placebo for arginine vasopressin
Other Names:
  • Kochsalz
  • Saline

Primary Outcome Measures :
  1. Primary end point will be hospital admission rate [ Time Frame: time from trauma to hospital admission ]

Secondary Outcome Measures :
  1. Hemodynamic variables [ Time Frame: time from trauma to hospital discharge ]
  2. Fluid resuscitation requirements [ Time Frame: time from trauma to hospital discharge ]
  3. Hospital discharge rate [ Time Frame: time from trauma to hospital discharge ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Adult trauma patients presenting with presumed traumatic hemorrhagic shock (systolic arterial blood pressure <90 mm Hg) that does not respond to the first 10 min of standard shock treatment [endotracheal intubation, crystalloid-, colloid-, and hypertonic saline (up to 4 ml/kg) fluid resuscitation, and catecholamine (ephedrine, phenylephrine, norepinephrine, epinephrine) vasopressors].

Exclusion Criteria:

  • Terminal illness
  • No intravenous access
  • Age < 18 years
  • Injury > 60 min before randomization
  • Known pregnancy
  • Cardiac arrest before randomization
  • Presence of a do-not-resuscitate order
  • Untreated tension pneumothorax
  • Untreated cardiac tamponade
  • Participation in another clinical study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00379522

HEMS Ybbsitz / Hospital Amstetten
Amstetten, Lower Austria, Austria, A-3300
Hospital Krems
Krems, Lower Austria, Austria, A-3500
Hospital Wiener Neustadt
Wiener Neustadt, Lower Austria, Austria, A-2700
Medical University of Graz
Graz, Styria, Austria, A-8036
Medical University of Innsbruck
Innsbruck, Tyrol, Austria, A-6020
Hospital Linz
Linz, Upper Austria, Austria, A-4021
HEMS Suben / Landeskrankenhaus Schärding
Schaerding, Upper Austria, Austria, A-4780
Hospital Salzburg
Salzburg, Austria, A-5020
University Hospital of Dresden
Dresden, Germany, D-01307
University Hospital of Goettingen
Goettingen, Germany, D-37075
University Hospital of Mannheim
Mannheim, Germany, D-68167
BG-Unfallklinik Murnau
Murnau, Germany, D-82418
Ev. Jung-Stilling-Krankenhaus
Siegen, Germany, D-57074
Bundeswehrkrankenhaus Ulm
Ulm, Germany, D-89070
Sponsors and Collaborators
Volker Wenzel
Study Chair: Prof. Dr. Volker Wenzel, M.Sc., M.D. Innsbruck Medical University, Dep. for Anaesthesia and Crit. Care Management

Additional Information:

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Volker Wenzel, Prof. Dr., Medical University Innsbruck Identifier: NCT00379522     History of Changes
Other Study ID Numbers: Vitris
First Posted: September 22, 2006    Key Record Dates
Last Update Posted: November 5, 2014
Last Verified: November 2014

Keywords provided by Volker Wenzel, Medical University Innsbruck:
shock treatment
Circulatory Collapse
Hypovolemic Shock

Additional relevant MeSH terms:
Shock, Hemorrhagic
Pathologic Processes
Arginine Vasopressin
Vasoconstrictor Agents
Antidiuretic Agents
Natriuretic Agents
Physiological Effects of Drugs