NCT00379522

Brief 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jul 2010

Typical duration for phase_2

Geographic Reach
2 countries

14 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 21, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 22, 2006

Completed
3.8 years until next milestone

Study Start

First participant enrolled

July 1, 2010

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

November 5, 2014

Status Verified

November 1, 2014

Enrollment Period

4.3 years

First QC Date

September 21, 2006

Last Update Submit

November 4, 2014

Conditions

ShockHypovolemiaHemorrhagic Shock

Keywords

hemorrhagicshocktraumaticshock treatmentvasopressinCirculatory CollapseHypovolemic Shock

Outcome Measures

Primary Outcomes (1)

  • Primary end point will be hospital admission rate

    time from trauma to hospital admission

Secondary Outcomes (3)

  • Hemodynamic variables

    time from trauma to hospital discharge

  • Fluid resuscitation requirements

    time from trauma to hospital discharge

  • Hospital discharge rate

    time from trauma to hospital discharge

Study Arms (2)

Vasopressin

ACTIVE COMPARATOR

Vasopressin, 10 I.U./4 ml, Solution for Injection

Drug: Vasopressin

Saline

PLACEBO COMPARATOR

Saline placebo 4 ml, Solution for Injection

Drug: Saline placebo

Interventions

VasopressinDRUG

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

Also known as: Pressyn, CPREssin, Pitressin
Vasopressin
Saline placeboDRUG

Placebo for arginine vasopressin

Also known as: Kochsalz, Saline
Saline

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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 \[endotracheal intubation, crystalloid-, colloid-, and hypertonic saline (up to 4 ml/kg) fluid resuscitation, and catecholamine (ephedrine, phenylephrine, norepinephrine, epinephrine) vasopressors\].

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

HEMS Ybbsitz / Hospital Amstetten

Amstetten, Lower Austria, A-3300, Austria

Location

Hospital Krems

Krems, Lower Austria, A-3500, Austria

Location

Hospital Wiener Neustadt

Wiener Neustadt, Lower Austria, A-2700, Austria

Location

Hospital Salzburg

Salzburg, Salzburg, A-5020, Austria

Location

Medical University of Graz

Graz, Styria, A-8036, Austria

Location

Medical University of Innsbruck

Innsbruck, Tyrol, A-6020, Austria

Location

Hospital Linz

Linz, Upper Austria, A-4021, Austria

Location

HEMS Suben / Landeskrankenhaus Schärding

Schärding, Upper Austria, A-4780, Austria

Location

University Hospital of Dresden

Dresden, D-01307, Germany

Location

University Hospital of Goettingen

Göttingen, D-37075, Germany

Location

University Hospital of Mannheim

Mannheim, D-68167, Germany

Location

BG-Unfallklinik Murnau

Murnau am Staffelsee, D-82418, Germany

Location

Ev. Jung-Stilling-Krankenhaus

Siegen, D-57074, Germany

Location

Bundeswehrkrankenhaus Ulm

Ulm, D-89070, Germany

Location

Related Publications (8)

  • 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.

    PMID: 15605286BACKGROUND

  • 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.

    PMID: 15843908BACKGROUND

  • 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.

    PMID: 15875138BACKGROUND

  • 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.

    PMID: 15155342BACKGROUND

  • 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.

    PMID: 16115999BACKGROUND

  • 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.

    PMID: 12606914BACKGROUND

  • 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.

    PMID: 12682488BACKGROUND

  • 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.

    PMID: 25947955DERIVED

Related Links

MeSH Terms

Conditions

ShockHypovolemiaShock, HemorrhagicDiabetes Insipidus

Interventions

VasopressinsSodium Chloride

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsHemorrhageKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesPituitary DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Pituitary Hormones, PosteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsOligopeptidesNerve Tissue ProteinsProteinsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

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

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

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

September 21, 2006

First Posted

September 22, 2006

Study Start

July 1, 2010

Primary Completion

October 1, 2014

Study Completion

October 1, 2014

Last Updated

November 5, 2014

Record last verified: 2014-11

Locations

DE(6)AU(8)