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Sponsored by: |
Medical University Innsbruck |
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Information provided by: | Medical University Innsbruck |
ClinicalTrials.gov Identifier: | NCT00379522 |
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 | Intervention | Phase |
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Shock Hypovolemia Hemorrhagic Shock |
Drug: Pressyn, arginine vasopressin Drug: Saline placebo |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver), Placebo Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Multicenter, Randomized, Controlled Trial Assessing Arginine Vasopressin Versus Saline Placebo in Refractory Traumatic Hemorrhagic Shock Patients (VITRIS-Study) |
Estimated Enrollment: | 200 |
Study Start Date: | January 2009 |
Estimated Study Completion Date: | April 2011 |
Estimated Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
arginine vasopressin
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Drug: Pressyn, arginine 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
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2: Placebo Comparator
Saline placebo
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Drug: Saline placebo
Placebo for arginine vasopressin
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Prof. Dr. Volker Wenzel, M.Sc. | +43 512 504 ext 80430 | volker.wenzel@uki.at |
Contact: Juergen Kaetzler | +43 512 504 ext 80472 | juergen.kaetzler@uki.at |
Study Chair: | Prof. Dr. Volker Wenzel, M.Sc., M.D. | Innsbruck Medical University, Dep. for Anaesthesia and Crit. Care Management |
Responsible Party: | Innsbruck Medical University - Dep. for Anaesthesia and Intensive Care Medicine ( Prof. Dr. Volker Wenzel, M.Sc. ) |
Study ID Numbers: | Vitris |
Study First Received: | September 21, 2006 |
Last Updated: | October 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00379522 History of Changes |
Health Authority: | Austria: Agency for Health and Food Safety; Germany: Federal Institute for Drugs and Medical Devices; Czech Republic: State Institute for Drug Control; France: Afssaps - French Health Products Safety Agency; Portugal: National Pharmacy and Medicines Institute |
hemorrhagic shock traumatic shock treatment |
vasopressin Circulatory Collapse Hypovolemic Shock |
Arginine Vasopressin Hypovolemia Shock Vasoconstrictor Agents Vasopressins |
Cardiovascular Agents Hemorrhage Hemostatics Shock, Hemorrhagic |
Hypovolemia Coagulants Hematologic Agents Physiological Effects of Drugs Cardiovascular Agents Hemorrhage Hemostatics Pharmacologic Actions Shock, Hemorrhagic |
Arginine Vasopressin Pathologic Processes Shock Natriuretic Agents Therapeutic Uses Vasopressins Vasoconstrictor Agents Antidiuretic Agents |