Vasopressin in Traumatic Hemorrhagic Shock Study
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| ClinicalTrials.gov Identifier: NCT00379522 |
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Recruitment Status :
Completed
First Posted : September 22, 2006
Last Update Posted : November 5, 2014
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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 or disease | Intervention/treatment | Phase |
|---|---|---|
| Shock Hypovolemia Hemorrhagic Shock | Drug: Vasopressin Drug: Saline placebo | Phase 2 Phase 3 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 64 participants |
| Allocation: | Randomized |
| Intervention Model: | Single Group Assignment |
| Masking: | Double (Participant, Care Provider) |
| Primary Purpose: | Treatment |
| Official Title: | A Multicenter, Randomized, Controlled Trial Assessing Arginine Vasopressin Versus Saline Placebo in Refractory Traumatic Hemorrhagic Shock Patients (VITRIS-study) |
| Study Start Date : | July 2010 |
| Actual Primary Completion Date : | October 2014 |
| Actual Study Completion Date : | October 2014 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Vasopressin
Vasopressin, 10 I.U./4 ml, Solution for Injection
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Drug: 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:
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Placebo Comparator: Saline
Saline placebo 4 ml, Solution for Injection
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Drug: Saline placebo
Placebo for arginine vasopressin
Other Names:
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- Primary end point will be hospital admission rate [ Time Frame: time from trauma to hospital admission ]
- Hemodynamic variables [ Time Frame: time from trauma to hospital discharge ]
- Fluid resuscitation requirements [ Time Frame: time from trauma to hospital discharge ]
- Hospital discharge rate [ Time Frame: time from trauma to hospital discharge ]
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, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00379522
| Austria | |
| HEMS Ybbsitz / Hospital Amstetten | |
| Amstetten, Lower Austria, Austria, A-3300 | |
| Hospital Krems | |
| Krems, Lower Austria, Austria, A-3500 | |
| Hospital Wiener Neustadt | |
| Wiener Neustadt, Lower Austria, Austria, A-2700 | |
| Medical University of Graz | |
| Graz, Styria, Austria, A-8036 | |
| Medical University of Innsbruck | |
| Innsbruck, Tyrol, Austria, A-6020 | |
| Hospital Linz | |
| Linz, Upper Austria, Austria, A-4021 | |
| HEMS Suben / Landeskrankenhaus Schärding | |
| Schaerding, Upper Austria, Austria, A-4780 | |
| Hospital Salzburg | |
| Salzburg, Austria, A-5020 | |
| Germany | |
| University Hospital of Dresden | |
| Dresden, Germany, D-01307 | |
| University Hospital of Goettingen | |
| Goettingen, Germany, D-37075 | |
| University Hospital of Mannheim | |
| Mannheim, Germany, D-68167 | |
| BG-Unfallklinik Murnau | |
| Murnau, Germany, D-82418 | |
| Ev. Jung-Stilling-Krankenhaus | |
| Siegen, Germany, D-57074 | |
| Bundeswehrkrankenhaus Ulm | |
| Ulm, Germany, D-89070 | |
| Study Chair: | Prof. Dr. Volker Wenzel, M.Sc., M.D. | Innsbruck Medical University, Dep. for Anaesthesia and Crit. Care Management |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Volker Wenzel, Prof. Dr., Medical University Innsbruck |
| ClinicalTrials.gov Identifier: | NCT00379522 |
| Other Study ID Numbers: |
Vitris |
| First Posted: | September 22, 2006 Key Record Dates |
| Last Update Posted: | November 5, 2014 |
| Last Verified: | November 2014 |
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hemorrhagic shock traumatic shock treatment |
vasopressin Circulatory Collapse Hypovolemic Shock |
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Shock Hypovolemia Shock, Hemorrhagic Pathologic Processes Hemorrhage Vasopressins Arginine Vasopressin |
Hemostatics Coagulants Vasoconstrictor Agents Antidiuretic Agents Natriuretic Agents Physiological Effects of Drugs |