Shock Clinical Trial
Official title:
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.
Status | Completed |
Enrollment | 64 |
Est. completion date | October 2014 |
Est. primary completion date | October 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Austria | HEMS Ybbsitz / Hospital Amstetten | Amstetten | Lower Austria |
Austria | Medical University of Graz | Graz | Styria |
Austria | Medical University of Innsbruck | Innsbruck | Tyrol |
Austria | Hospital Krems | Krems | Lower Austria |
Austria | Hospital Linz | Linz | Upper Austria |
Austria | Hospital Salzburg | Salzburg | |
Austria | HEMS Suben / Landeskrankenhaus Schärding | Schaerding | Upper Austria |
Austria | Hospital Wiener Neustadt | Wiener Neustadt | Lower Austria |
Germany | University Hospital of Dresden | Dresden | |
Germany | University Hospital of Goettingen | Goettingen | |
Germany | University Hospital of Mannheim | Mannheim | |
Germany | BG-Unfallklinik Murnau | Murnau | |
Germany | Ev. Jung-Stilling-Krankenhaus | Siegen | |
Germany | Bundeswehrkrankenhaus Ulm | Ulm |
Lead Sponsor | Collaborator |
---|---|
Volker Wenzel |
Austria, Germany,
Krismer AC, Wenzel V, Voelckel WG, Innerhofer P, Stadlbauer KH, Haas T, Pavlic M, Sparr HJ, Lindner KH, Koenigsrainer A. Employing vasopressin as an adjunct vasopressor in uncontrolled traumatic hemorrhagic shock. Three cases and a brief analysis of the literature. Anaesthesist. 2005 Mar;54(3):220-4. — View Citation
Raedler C, Voelckel WG, Wenzel V, Krismer AC, Schmittinger CA, Herff H, Mayr VD, Stadlbauer KH, Lindner KH, Königsrainer A. Treatment of uncontrolled hemorrhagic shock after liver trauma: fatal effects of fluid resuscitation versus improved outcome after vasopressin. Anesth Analg. 2004 Jun;98(6):1759-66, table of contents. — View Citation
Schummer W, Schummer C, Fuchs J. [Vasopressin]. Anaesthesist. 2005 Jul;54(7):707-8. German. — View Citation
Stadlbauer KH, Wagner-Berger HG, Raedler C, Voelckel WG, Wenzel V, Krismer AC, Klima G, Rheinberger K, Nussbaumer W, Pressmar D, Lindner KH, Königsrainer A. Vasopressin, but not fluid resuscitation, enhances survival in a liver trauma model with uncontrolled and otherwise lethal hemorrhagic shock in pigs. Anesthesiology. 2003 Mar;98(3):699-704. — View Citation
Stadlbauer KH, Wenzel V, Krismer AC, Voelckel WG, Lindner KH. Vasopressin during uncontrolled hemorrhagic shock: less bleeding below the diaphragm, more perfusion above. Anesth Analg. 2005 Sep;101(3):830-2. — View Citation
Tsuneyoshi I, Onomoto M, Yonetani A, Kanmura Y. Low-dose vasopressin infusion in patients with severe vasodilatory hypotension after prolonged hemorrhage during general anesthesia. J Anesth. 2005;19(2):170-3. — View Citation
Voelckel WG, Raedler C, Wenzel V, Lindner KH, Krismer AC, Schmittinger CA, Herff H, Rheinberger K, Königsrainer A. Arginine vasopressin, but not epinephrine, improves survival in uncontrolled hemorrhagic shock after liver trauma in pigs. Crit Care Med. 2003 Apr;31(4):1160-5. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Primary end point will be hospital admission rate | time from trauma to hospital admission | No | |
Secondary | Hemodynamic variables | time from trauma to hospital discharge | No | |
Secondary | Fluid resuscitation requirements | time from trauma to hospital discharge | No | |
Secondary | Hospital discharge rate | time from trauma to hospital discharge | No |
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