Status:
COMPLETED
Vasopressin in Traumatic Hemorrhagic Shock Study
Lead Sponsor:
Volker Wenzel
Conditions:
Shock
Hypovolemia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief 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 resus...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2014
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT00379522
Start Date
July 1 2010
End Date
October 1 2014
Last Update
November 5 2014
Active Locations (14)
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1
HEMS Ybbsitz / Hospital Amstetten
Amstetten, Lower Austria, Austria, A-3300
2
Hospital Krems
Krems, Lower Austria, Austria, A-3500
3
Hospital Wiener Neustadt
Wiener Neustadt, Lower Austria, Austria, A-2700
4
Hospital Salzburg
Salzburg, Salzburg, Austria, A-5020