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Vasopressin in Traumatic Hemorrhagic Shock Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Volker Wenzel, Medical University Innsbruck
ClinicalTrials.gov Identifier:
NCT00379522
First received: September 21, 2006
Last updated: November 4, 2014
Last verified: November 2014

September 21, 2006
November 4, 2014
July 2010
October 2014   (final data collection date for primary outcome measure)
Primary end point will be hospital admission rate [ Time Frame: time from trauma to hospital admission ] [ Designated as safety issue: No ]
Primary end point will be hospital admission rate
Complete list of historical versions of study NCT00379522 on ClinicalTrials.gov Archive Site
  • Hemodynamic variables [ Time Frame: time from trauma to hospital discharge ] [ Designated as safety issue: No ]
  • Fluid resuscitation requirements [ Time Frame: time from trauma to hospital discharge ] [ Designated as safety issue: No ]
  • Hospital discharge rate [ Time Frame: time from trauma to hospital discharge ] [ Designated as safety issue: No ]
  • hemodynamic variables
  • luid resuscitation requirements
  • hospital discharge rate
Not Provided
Not Provided
 
Vasopressin in Traumatic Hemorrhagic Shock Study
A Multicenter, Randomized, Controlled Trial Assessing Arginine Vasopressin Versus Saline Placebo in Refractory Traumatic Hemorrhagic Shock Patients (VITRIS-study)

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.

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.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
  • Shock
  • Hypovolemia
  • Hemorrhagic Shock
  • 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
    • Vasopressin
  • Drug: Saline placebo
    Placebo for arginine vasopressin
    Other Names:
    • Kochsalz
    • Saline
  • Active Comparator: Vasopressin
    Vasopressin, 10 I.U./4 ml, Solution for Injection
    Intervention: Drug: Vasopressin
  • Placebo Comparator: Saline
    Saline placebo 4 ml, Solution for Injection
    Intervention: Drug: Saline placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
64
October 2014
October 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Austria,   Germany
 
NCT00379522
Vitris
Yes
Volker Wenzel, Medical University Innsbruck
Volker Wenzel
Not Provided
Study Chair: Prof. Dr. Volker Wenzel, M.Sc., M.D. Innsbruck Medical University, Dep. for Anaesthesia and Crit. Care Management
Medical University Innsbruck
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP