Vasopressin in Traumatic Hemorrhagic Shock Study

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2008 by Medical University Innsbruck.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Medical University Innsbruck
ClinicalTrials.gov Identifier:
NCT00379522
First received: September 21, 2006
Last updated: October 9, 2008
Last verified: October 2008
  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 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Controlled Trial Assessing Arginine Vasopressin Versus Saline Placebo in Refractory Traumatic Hemorrhagic Shock Patients (VITRIS-Study)

Resource links provided by NLM:


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
Active Comparator: 1
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
Other Names:
  • Pressyn
  • CPREssin
  • Pitressin
  • Vasopressin
Placebo Comparator: 2
Saline placebo
Drug: Saline placebo
Placebo for arginine vasopressin
Other Names:
  • Kochsalz
  • Saline

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Hide Study Locations
Locations
Austria
LKH Klagenfurt Not yet recruiting
Klagenfurt, Carinthia, Austria, A-9026
Contact: Prof. Dr. Rudolf Likar, M.D.    +43 (0)463 538 ext 23703    rudolf.likar@kabeg.at   
Principal Investigator: Prof. Dr. Rudolf Likar, M.D.         
HEMS Ybbsitz / Hospital Amstetten Not yet recruiting
Amstetten, Lower Austria, Austria, A-3300
Contact: Peter Siebrecht, Dr.    +43 (0)7472 604 ext 6518    peter.siebrecht@amstetten.lknoe.at   
Principal Investigator: Peter Siebrecht, M.D.         
Hospital Krems Not yet recruiting
Krems, Lower Austria, Austria, A-3500
Contact: Gabriele Golling, OA Dr.    +43 (0)2732 804 0    gabi.golling@aon.at   
Principal Investigator: Gabriele Golling, M.D.         
Hospital Wiener Neustadt Not yet recruiting
Wiener Neustadt, Lower Austria, Austria, A-2700
Contact: Helmut Trimmel, Prim. Dr.    +43 (0)2622 321 ext 3851    helmut.trimmel@wienerneustadt.lknoe.at   
Principal Investigator: Helmut Trimmel, M.D.         
Medical University of Graz Not yet recruiting
Graz, Styria, Austria, A-8036
Contact: Drago Dacar, Prof. Dr.    +43 (0)316 385 ext 82839    drago.dacar@meduni-graz.at   
Contact: Thomas Raber, Dr. med.    +43 (0)316 385 ext 81759    thomas.raber@meduni-graz.at   
Principal Investigator: Drago Dacar, M.D.         
Sub-Investigator: Thomas Raber, M.D.         
Medical University of Innsbruck Not yet recruiting
Innsbruck, Tyrol, Austria, A-6020
Contact: Wolfgang Voelckel, Prof. Dr.    +43 (0)512 504 ext 80272    wolfgang.voelckel@uki.at   
Contact: Volker Wenzel, Prof. Dr.    +43 (0)512 504 ext 80430    volker.wenzel@uki.at   
Principal Investigator: Wolfgang Voelckel, M.D.         
HEMS Zams Not yet recruiting
Zams, Tyrol, Austria, A-6511
Contact: Gilbert Posch, Dr.    +43 (0)512 504 ext 26128    gilbert.posch@oeamtc.at   
Principal Investigator: Gilbert Posch, M.D.         
Hospital Linz Not yet recruiting
Linz, Upper Austria, Austria, A-4021
Contact: Hans Gombotz, Prof. Dr.    +43 (0)732 7806 ext 2157    hans.gombotz@akh.linz.at   
Principal Investigator: Hans Gombotz, M.D.         
HEMS Suben / Landeskrankenhaus Schärding Not yet recruiting
Schaerding, Upper Austria, Austria, A-4780
Contact: Peter Hatzl, OA Dr.    +43 (0)7712 3141 ext 22706    peter.hatzl@oeamtc.at   
Principal Investigator: Peter Hatzl, M.D.         
Hospital Salzburg Not yet recruiting
Salzburg, Austria, A-5020
Contact: Franz Chmelizek, Prim. Dr.    +43 (0)662 4482 ext 57565    F.Chmelizek@salk.at   
Principal Investigator: Franz Chmelizek, M.D.         
Czech Republic
HEMS "Christoph 6" Hradec Kralove Not yet recruiting
Hradec Kralove, Czech Republic, CZ-500 12
Contact: Anatolij Truhlar, M.D    +420 606 816 818    ATruhlar@seznam.cz   
Principal Investigator: Anatolij Truhlar, M.D.         
France
Centre Hospitalier Universitaire de Grenoble B.P. 217 Not yet recruiting
Grenoble cedex 09, France, 38043
Contact: Dr. Michael Ladwig, M.D.    +33 476 63 42 45    MLadwig@chu-grenoble.fr   
Contact: Dr. Elisabeth Rancurel, M.D.    +33 476 63 42 41    ERancurel-@chu-grenoble.fr   
Principal Investigator: Dr. Michael Ladwig, M.D.         
Sub-Investigator: Dr. Elisabeth Rancurel, M.D.         
Germany
Charité Berlin / Campus Benjamin Franklin Not yet recruiting
Berlin, Germany, D-12200
Contact: Hans-Richard Arntz, Prof. Dr.    +49 (0)30 8445 ext 2640    hans-richard.arntz@charite.de   
Contact: Martina Weiland    +49 (0)30 8445 ext 2640    martina.weiland@charite.de   
Principal Investigator: Hans-Richard Arntz, M.D.         
Klinikum Links der Weser Not yet recruiting
Bremen, Germany, D-28277
Contact: Gerald Bandemer, Dr.    +49 (0)421 8790 ext 224    gerald.bandemer@klinikum-bremen-ldw.de   
Contact: Andreas Callies, Dr.    +49 (0)421 8792 ext 679    andreas.callies@klinikum-bremen-ldw.de   
Principal Investigator: Gerald Bandemer, M.D.         
Sub-Investigator: Andreas Callies, M.D.         
University Hospital of Dresden Not yet recruiting
Dresden, Germany, D-01307
Contact: Mark Frank, Dr.    +49 (0)351 458 ext 2785    mark.frank@t-online.de   
Principal Investigator: Mark Frank, M.D.         
Luftrettungszentrum der DRF e.V. Not yet recruiting
Freiburg, Germany, D-79108
Contact: Michael Krapf, Dr. med.    +49 (0)761 2711 ext 5120    michael.krapf@drf.de   
Principal Investigator: Michael Krapf, M.D.         
Klinikum Fulda gAG Not yet recruiting
Fulda, Germany, D-36043
Contact: Peter Muenstedt, OA Dr.    +49 (0)661 84 ext 6045    peter.muenstedt@klinikum-fulda.de   
Contact: Wolfram Beres, Dr.       wolfram.beres@klinikum-fulda.de   
Principal Investigator: Peter Muenstedt, M.D.         
Sub-Investigator: Wolfram Beres, M.D.         
University Hospital of Goettingen Not yet recruiting
Goettingen, Germany, D-37075
Contact: Markus Roessler, Dr.    +49 (0)551 398 ext 826    mroessl1@gwdg.de   
Principal Investigator: Markus Roessler, M.D.         
University Hospital of Greifswald Not yet recruiting
Greifswald, Germany, D-17487
Contact: Lutz Fischer, OA Dr.    +49 (0)3834 816 ext 140    fischerl@uni-greifswald.de   
Principal Investigator: Lutz Fischer, M.D.         
Klinikum Ingolstadt Not yet recruiting
Ingolstadt, Germany, D-85021
Contact: Ferdinand Rothmeier, Dr.    +49 (0)841 880 ext 2353    ferdinand.rothmeier@klinikum-ingolstadt.de   
Principal Investigator: Ferdinand Rothmeier, M.D.         
University Hospital of Jena Not yet recruiting
Jena, Germany, D-07740
Contact: Jens Reichel, OA Dr.    +49 (0)3641 933 ext 634    JENS.Reichel@med.uni-jena.de   
Principal Investigator: Jens Reichel, M.D.         
St. Vincentius Krankenhaeuser Not yet recruiting
Karlsruhe, Germany, D-76135
Contact: Thomas Mueller, OA Dr.    +49 (0)721 81 ext 8066    thomas.mueller@vincentius-ka.de   
Principal Investigator: Thomas Mueller, M.D.         
University Hospital of Schleswig-Holstein / Campus Kiel Not yet recruiting
Kiel, Germany, D-24105
Contact: Volker Doerges, Prof. Dr.    +49 (0)431 597 ext 3688    doerges@anaesthesie.uni-kiel.de   
Contact: Florian Reifferscheid, Dr.       reifferscheid@anaesthesie.uni-kiel.de   
Principal Investigator: Volker Doerges, M.D.         
Sub-Investigator: Florian Reifferscheid, M.D.         
Bundeswehrzentralkrankenhaus Koblenz Not yet recruiting
Koblenz, Germany, D-56072
Contact: Jens Schwietring, OSA Dr.    +49 (0)261 281 ext 3005    jens.schwietring@bundeswehr.org   
Principal Investigator: Jens Schwietring, M.D.         
Hospital Leonberg Not yet recruiting
Leonberg, Germany, D-71229
Contact: Klaus Geitner, Dr.    +49 (0)7152 202 ext 4390    k.geitner@klinikverbund-suedwest.de   
Principal Investigator: Klaus Geitner, M.D.         
University Hospital of Mannheim Not yet recruiting
Mannheim, Germany, D-68167
Contact: Tim Viergutz, Dr.    +49 (0)621 383 ext 2415    tim.viergutz@anaes.ma.uni-heidelberg.de   
Contact: Christian Heiner, Dr.    +49 (0)621 383 0    christian.heiner@drf.de   
Principal Investigator: Tim Viergutz, M.D.         
Sub-Investigator: Christian Heiner, M.D.         
Krankenhaus Muenchen Harlaching Not yet recruiting
Munich, Germany, D-81545
Contact: Philipp Bender, Dr.    +49 (0)89 6210 ext 2410    philipp.meyer-bender@christoph-1.de   
Contact: Erwin Stolpe, Dr.    +49 (0)89 6210 ext 2222    erwin.stolpe@med.uni-muenchen.de   
Principal Investigator: Philipp Meyer-Bender, M.D.         
Sub-Investigator: Erwin Stolpe, M.D.         
BG-Unfallklinik Murnau Not yet recruiting
Murnau, Germany, D-82418
Contact: Thomas van Boemmel, OA Dr.    +49 (0)8841 48 ext 2626    vanboemmel@bgu-murnau.de   
Principal Investigator: Thomas van Boemmel, M.D.         
Main-Klinik Ochsenfurt Not yet recruiting
Ochsenfurt, Germany, D-97199
Contact: Erdmuthe Hummel, Dr.    +49 (0)9331 908 ext 4666    erdmuthe.hummel@drf.de   
Principal Investigator: Erdmuthe Hummel, M.D.         
University Hospital of Regensburg Not yet recruiting
Regensburg, Germany, D-93042
Contact: Markus Zimmermann, OA Dr.    +49 (0)941 944 ext 7801    markus.zimmermann@klinik.uni-regensburg.de   
Principal Investigator: Markus Zimmermann, M.D.         
RZV Saar / Klinikum Saarbrücken Not yet recruiting
Saarbruecken, Germany, D-66450
Contact: Thomas Schlechtriemen, Dr.    +49 (0)6826 931 ext 534    Schlechtriemen@rzv-saar.de   
Principal Investigator: Thomas Schlechtriemen, M.D.         
Ev. Jung-Stilling-Krankenhaus Not yet recruiting
Siegen, Germany, D-57074
Contact: Martin Hoeser, Dr. med.    +49 (0)271 333 ext 40322    martin.hoeser@web.de   
Principal Investigator: Martin Hoeser, M.D.         
Klinikum Schillerhoehe Not yet recruiting
Stuttgart, Germany, D-70624
Contact: Reinhard Jaki, Dr.    +49 (0)711 7943 965    jaki@klinik-schillerhoehe.de   
Principal Investigator: Reinhard Jaki, M.D.         
Klinikum Suhl Not yet recruiting
Suhl, Germany, D-98527
Contact: Eva Fritz, Dr.    +49 (0)3681 303 910    eva.fritz@zs.srh.de   
Principal Investigator: Eva Fritz, M.D.         
Bundeswehrkrankenhaus Ulm Not yet recruiting
Ulm, Germany, D-89070
Contact: Matthias Helm, Dr. med.    +49 (0)731 1710 ext 2000    matthias.helm@extern.uni-ulm.de   
Principal Investigator: Matthias Helm, M.D.         
Schwarzwald-Baar-Klinikum Not yet recruiting
Villingen-Schwenningen, Germany, D-78054
Contact: Rainer Gojowczyk, OA Dr.    +49 (0)7720 93 ext 2553    rainer.gojowczyk@sbk-vs.de   
Principal Investigator: Rainer Gojowczyk, M.D.         
St. Elisabeth Krankenhaus Withdrawn
Wittlich, Germany, D-54516
Medizinisches Zentrum Kreis Aachen Not yet recruiting
Wuerselen, Germany, D-52146
Contact: Wolfang Jussen, Dr.    +49 (0)2405 62 0    woljus@web.de   
Principal Investigator: Wolfgang Jussen, M.D.         
Paracelsus Klinik Zwickau Not yet recruiting
Zwickau, Germany, D-08009
Contact: Klaus Koehler, Dr.    +49 (0)375 560 ext 9226    k.koehler@t-online.de   
Principal Investigator: Klaus Koehler, M.D.         
Italy
Suedtiroler Landesflugrettung Bozen Not yet recruiting
Bozen, Italy, I-39100
Contact: Ernst Fop, Dr.    +39 (0)471 416 ext 221    ernst.fop@provinz.bz.it   
Principal Investigator: Ernst Fop, M.D.         
Netherlands
Groningen Not yet recruiting
Groningen, Netherlands
Contact: Jens P. Valk, Dr.    +31 50 36 197 80    j.p.valk@anest.umcg.nl   
Principal Investigator: Jens P. Valk, M.D.         
Portugal
Lissabon Not yet recruiting
Lisbon, Portugal
Contact: Richard Glied, M.D.    00351 967101648    richard.glied@inem.pt   
Contact: Isabel Santos, M.D.       isabel.santos@inem.pt   
Principal Investigator: Richard Glied, M.D.         
Porto Not yet recruiting
Porto, Portugal
Contact: Nelson Pereira, Dr.       nelson.pereira@inem.pt   
Principal Investigator: Nelson Pereira, M.D.         
Switzerland
University Hospital of Basel Not yet recruiting
Basel, Switzerland, CH-4031
Contact: Wolfgang Ummenhofer, Prof. Dr.    +41 (0)61 265 ext 7254    wummenhofer@uhbs.ch   
Contact: Mathias Zuercher, Dr.       zumthis@bluewin.ch   
Principal Investigator: Wolfgang Ummenhofer, M.D:         
Sub-Investigator: Andreas Glatz, M.D.         
Sub-Investigator: Mathias Zuercher, M.D.         
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

Additional Information:
Publications:

Responsible Party: Prof. Dr. Volker Wenzel, M.Sc., Innsbruck Medical University - Dep. for Anaesthesia and Intensive Care Medicine
ClinicalTrials.gov Identifier: NCT00379522     History of Changes
Other Study ID Numbers: Vitris
Study First Received: September 21, 2006
Last Updated: October 9, 2008
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 - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Portugal: National Pharmacy and Medicines Institute

Keywords provided by Medical University Innsbruck:
hemorrhagic
shock
traumatic
shock treatment
vasopressin
Circulatory Collapse
Hypovolemic Shock

Additional relevant MeSH terms:
Shock
Shock, Hemorrhagic
Hypovolemia
Pathologic Processes
Hemorrhage
Arginine Vasopressin
Vasopressins
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Vasoconstrictor Agents
Cardiovascular Agents
Antidiuretic Agents
Natriuretic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 28, 2014