Trial record 8 of 11 for:    Open Studies | "Diabetes Insipidus"

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

  Show 44 Study Locations
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:
Hypovolemia
Shock
Shock, Hemorrhagic
Hemorrhage
Pathologic Processes
Arginine Vasopressin
Vasopressins
Antidiuretic Agents
Cardiovascular Agents
Coagulants
Hematologic Agents
Hemostatics
Natriuretic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Vasoconstrictor Agents

ClinicalTrials.gov processed this record on October 22, 2014