Vasopressin in Traumatic Hemorrhagic Shock Study - Full Text View

Sponsored by:	Medical University Innsbruck
Information provided by:	Medical University Innsbruck
ClinicalTrials.gov Identifier:	NCT00379522

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 II Phase III

Drug Information available for: Sodium chloride Arginine Arginine hydrochloride Argipressin Vasopressins

U.S. FDA Resources

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)

Further study details as provided by Medical University Innsbruck:

Primary Outcome Measures:

Primary end point will be hospital admission rate [ Time Frame: time from trauma to hospital admission ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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
1: Active Comparator 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
2: Placebo Comparator Saline placebo	Drug: Saline placebo Placebo for arginine vasopressin

Arms

Assigned Interventions

1: Active Comparator

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

2: Placebo Comparator

Saline placebo

Drug: Saline placebo

Placebo for arginine vasopressin

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

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00379522

Contacts

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 43 Study Locations

Sponsors and Collaborators

Medical University Innsbruck

Investigators

Study Chair:

Prof. Dr. Volker Wenzel, M.Sc., M.D.

Innsbruck Medical University, Dep. for Anaesthesia and Crit. Care Management

More Information

Related Info This link exits the ClinicalTrials.gov site

Publications:

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.

Schummer W, Schummer C, Fuchs J. [Vasopressin] Anaesthesist. 2005 Jul;54(7):707-8. German. No abstract available.

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.

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):1759-66, table of contents.

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. 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.

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.

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
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

Keywords provided by Medical University Innsbruck:

hemorrhagic
shock
traumatic
shock treatment

vasopressin
Circulatory Collapse
Hypovolemic Shock

Study placed in the following topic categories:

Arginine Vasopressin
Hypovolemia
Shock

Vasopressins
Hemorrhage
Shock, Hemorrhagic

Additional relevant MeSH terms:

Pathologic Processes
Coagulants
Natriuretic Agents
Therapeutic Uses
Hematologic Agents
Physiological Effects of Drugs

Vasoconstrictor Agents
Cardiovascular Agents
Antidiuretic Agents
Hemostatics
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009