Vasopressin in Traumatic Hemorrhagic Shock Study
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Purpose
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 |
|---|---|---|
|
Shock Hypovolemia Hemorrhagic Shock |
Drug: Pressyn, arginine vasopressin Drug: Saline placebo |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Caregiver) Primary Purpose: Treatment |
| Official Title: | A Multicenter, Randomized, Controlled Trial Assessing Arginine Vasopressin Versus Saline Placebo in Refractory Traumatic Hemorrhagic Shock Patients (VITRIS-Study) |
- Primary end point will be hospital admission rate [ Time Frame: time from trauma to hospital admission ] [ Designated as safety issue: No ]
- 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 ]
| 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 |
|---|---|
|
Active Comparator: 1
arginine vasopressin
|
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
Other Names:
|
|
Placebo Comparator: 2
Saline placebo
|
Drug: Saline placebo
Placebo for arginine vasopressin
Other Names:
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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.
Contacts and Locations| 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 |
Show 44 Study Locations| Study Chair: | Prof. Dr. Volker Wenzel, M.Sc., M.D. | Innsbruck Medical University, Dep. for Anaesthesia and Crit. Care Management |
More Information
Additional Information:
Publications:
| Responsible Party: | Prof. Dr. Volker Wenzel, M.Sc., Innsbruck Medical University - Dep. for Anaesthesia and Intensive Care Medicine |
| ClinicalTrials.gov Identifier: | NCT00379522 History of Changes |
| Other Study ID Numbers: | Vitris |
| Study First Received: | September 21, 2006 |
| Last Updated: | October 9, 2008 |
| 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 - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Portugal: National Pharmacy and Medicines Institute |
Keywords provided by Medical University Innsbruck:
|
hemorrhagic shock traumatic shock treatment |
vasopressin Circulatory Collapse Hypovolemic Shock |
Additional relevant MeSH terms:
|
Shock Shock, Hemorrhagic Hypovolemia Pathologic Processes Hemorrhage Arginine Vasopressin Vasopressins Hemostatics Coagulants |
Hematologic Agents Therapeutic Uses Pharmacologic Actions Vasoconstrictor Agents Cardiovascular Agents Antidiuretic Agents Natriuretic Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 19, 2013