Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
64 participants
INTERVENTIONAL
2010-07-31
2014-10-31
Brief Summary
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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.
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Detailed Description
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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appendix for patient information sheet); the protocol specifies that if there are any objections, the patient will be withdrawn from the study.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.
Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
DOUBLE
Study Groups
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Vasopressin
Vasopressin, 10 I.U./4 ml, Solution for Injection
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
Saline
Saline placebo 4 ml, Solution for Injection
Saline placebo
Placebo for arginine vasopressin
Interventions
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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
Saline placebo
Placebo for arginine vasopressin
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Volker Wenzel
OTHER
Responsible Party
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Volker Wenzel
Prof. Dr.
Principal Investigators
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Prof. Dr. Volker Wenzel, M.Sc., M.D.
Role: STUDY_CHAIR
Innsbruck Medical University, Dep. for Anaesthesia and Crit. Care Management
Locations
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HEMS Ybbsitz / Hospital Amstetten
Amstetten, Lower Austria, Austria
Hospital Krems
Krems, Lower Austria, Austria
Hospital Wiener Neustadt
Wiener Neustadt, Lower Austria, Austria
Hospital Salzburg
Salzburg, Salzburg, Austria
Medical University of Graz
Graz, Styria, Austria
Medical University of Innsbruck
Innsbruck, Tyrol, Austria
Hospital Linz
Linz, Upper Austria, Austria
HEMS Suben / Landeskrankenhaus Schärding
Schärding, Upper Austria, Austria
University Hospital of Dresden
Dresden, , Germany
University Hospital of Goettingen
Göttingen, , Germany
University Hospital of Mannheim
Mannheim, , Germany
BG-Unfallklinik Murnau
Murnau am Staffelsee, , Germany
Ev. Jung-Stilling-Krankenhaus
Siegen, , Germany
Bundeswehrkrankenhaus Ulm
Ulm, , Germany
Countries
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References
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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. doi: 10.1007/s00101-004-0793-y.
Schummer W, Schummer C, Fuchs J. [Vasopressin]. Anaesthesist. 2005 Jul;54(7):707-8. doi: 10.1007/s00101-005-0854-x. No abstract available. German.
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. doi: 10.1007/s00540-004-0299-4.
Raedler C, Voelckel WG, Wenzel V, Krismer AC, Schmittinger CA, Herff H, Mayr VD, Stadlbauer KH, Lindner KH, Konigsrainer 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):1759-1766. doi: 10.1213/01.ANE.0000117150.29361.5A.
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):830-832. doi: 10.1213/01.ANE.0000175217.55775.1C. No abstract available.
Stadlbauer KH, Wagner-Berger HG, Raedler C, Voelckel WG, Wenzel V, Krismer AC, Klima G, Rheinberger K, Nussbaumer W, Pressmar D, Lindner KH, Konigsrainer 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. doi: 10.1097/00000542-200303000-00018.
Voelckel WG, Raedler C, Wenzel V, Lindner KH, Krismer AC, Schmittinger CA, Herff H, Rheinberger K, Konigsrainer 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. doi: 10.1097/01.CCM.0000060014.75282.69.
O'Callaghan DJ, Gordon AC. What's new in vasopressin? Intensive Care Med. 2015 Dec;41(12):2177-9. doi: 10.1007/s00134-015-3849-3. Epub 2015 May 7. No abstract available.
Related Links
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Study Homepage
Other Identifiers
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Vitris
Identifier Type: -
Identifier Source: org_study_id
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