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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00379522
Other study ID # Vitris
Secondary ID
Status Completed
Phase Phase 2/Phase 3
First received September 21, 2006
Last updated November 4, 2014
Start date July 2010
Est. completion date October 2014

Study information

Verified date November 2014
Source Medical University Innsbruck
Contact n/a
Is FDA regulated No
Health authority Austria: Agency for Health and Food SafetyGermany: Federal Institute for Drugs and Medical Devices
Study type Interventional

Clinical Trial Summary

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.


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 (ยง43a 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.


Recruitment information / eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
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

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Volker Wenzel

Countries where clinical trial is conducted

Austria,  Germany, 

References & Publications (7)

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

Outcome

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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