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ShockPhase 2/3NCT00379522

Vasopressin in Traumatic Hemorrhagic Shock Study

A Phase 2/3 study testing Vasopressin in people with Shock and Hypovolemia, run by Volker Wenzel at 14 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Shock, Hypovolemia, Hemorrhagic Shock
What is being tested?
Vasopressin
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
64 participants
Where
14 sitesin 2 countries
Study dates
Jul 2010to Oct 2014
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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].

Who cannot join

  • Terminal illness
  • No intravenous access
  • Age < 18 years
  • Injury > 60 min before randomization
  • Known pregnancy
  • Cardiac arrest before randomization
Show all 10Show fewer
  • Presence of a do-not-resuscitate order
  • Untreated tension pneumothorax
  • Untreated cardiac tamponade
  • Participation in another clinical study.

Trial locations and contacts

14 sites in 2 countries.

14 sites in 2 countries

Austria8 sites

  • HEMS Ybbsitz / Hospital Amstetten

    Amstetten, Lower Austria, A-3300

  • Medical University of Graz

    Graz, Styria, A-8036

  • Medical University of Innsbruck

    Innsbruck, Tyrol, A-6020

  • Hospital Krems

    Krems, Lower Austria, A-3500

  • Hospital Linz

    Linz, Upper Austria, A-4021

  • Hospital Salzburg

    Salzburg, State of Salzburg, A-5020

  • HEMS Suben / Landeskrankenhaus Schärding

    Schaerding, Upper Austria, A-4780

  • Hospital Wiener Neustadt

    Wiener Neustadt, Lower Austria, A-2700

Other trials in Austria

Germany6 sites

  • University Hospital of Dresden

    Dresden, D-01307

  • University Hospital of Goettingen

    Göttingen, D-37075

  • University Hospital of Mannheim

    Mannheim, D-68167

  • BG-Unfallklinik Murnau

    Murnau am Staffelsee, D-82418

  • Ev. Jung-Stilling-Krankenhaus

    Siegen, D-57074

  • Bundeswehrkrankenhaus Ulm

    Ulm, D-89070

Other trials in Germany

About this study

Official title: A Multicenter, Randomized, Controlled Trial Assessing Arginine Vasopressin Versus Saline Placebo in Refractory Traumatic Hemorrhagic Shock Patients (VITRIS-study)

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.

Read the 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.

Being tested
Vasopressin, Saline placebo
Keywords
hemorrhagic, shock, traumatic, shock treatment, vasopressin, Circulatory Collapse, Hypovolemic Shock
Medical subject headings
Shock, Hypovolemia, Shock, Hemorrhagic, Diabetes Insipidus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VasopressinDrug

    Also called Pressyn, CPREssin, Pitressin

    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 placeboDrug

    Also called Kochsalz, Saline

    Placebo for arginine vasopressin

Study groups in NCT00379522
Study groupRoleWhat they receive
VasopressinActive comparatorVasopressin, 10 I.U./4 ml, Solution for Injection
Receives: Drug: Vasopressin
SalinePlacebo comparatorSaline placebo 4 ml, Solution for Injection
Receives: Drug: Saline placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Primary end point will be hospital admission rate

    Measured: time from trauma to hospital admission

Secondary outcomes (3)

  1. Hemodynamic variables

    Measured: time from trauma to hospital discharge

  2. Fluid resuscitation requirements

    Measured: time from trauma to hospital discharge

  3. Hospital discharge rate

    Measured: time from trauma to hospital discharge

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Sep 2006 (estimated)
  2. Study startJul 2010
  3. Primary completionOct 2014
  4. Study completionOct 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
64 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00379522
Sponsor's protocol ID
Vitris
Status last verified
Nov 2014
First submitted
21 Sep 2006
Last updated
5 Nov 2014
Results posted
No
Data monitoring committee
Yes

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. doi: 10.1007/s00101-004-0793-y.

    PubMed 15605286

  • 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.

    PubMed 15843908

  • 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.

    PubMed 15875138

  • 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.

    PubMed 15155342

  • 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.

    PubMed 16115999

  • 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.

    PubMed 12606914

  • 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.

    PubMed 12682488

  • 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.

    PubMed 25947955

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Vasopressin in people with Shock and Hypovolemia, run by Volker Wenzel at 14 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in Austria, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary end point will be hospital admission rate (time frame: time from trauma to hospital admission). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00379522, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2014.

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