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
Recruitment status was Not yet recruiting
Sponsor:
Medical University Innsbruck
Information provided by:
Medical University Innsbruck
ClinicalTrials.gov Identifier:
NCT00379522
First received: September 21, 2006
Last updated: October 9, 2008
Last verified: October 2008
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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:
|
|
Placebo Comparator: 2
Saline placebo
|
Drug: Saline placebo
Placebo for arginine vasopressin
Other Names:
|
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
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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 LocationsLocations
| 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 May 21, 2013