Status:
TERMINATED
Hypertonic Resuscitation Following Traumatic Injury
Lead Sponsor:
University of Washington
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
National Institute of Neurological Disorders and Stroke (NINDS)
Conditions:
Shock, Traumatic
Eligibility:
All Genders
15+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to determine if hypertonic saline with and without dextran can improve overall survival in victims of trauma with shock. Injury and lost blood from trauma can cause your ...
Detailed Description
Specific Aim: To determine if prehospital administration of 7.5% hypertonic saline /6% Dextran-70 (HSD) OR 7.5% hypertonic saline alone (HS), compared to current standard therapy with normal saline (N...
Eligibility Criteria
Inclusion
- Blunt or penetrating trauma
- Prehospital Systolic Blood Pressure (SBP) \<= 70;OR
- Prehospital SBP 71-90 AND Hear Rate (HR) ≥108
- 15 years of age or older, or 50kg or more if age unknown
Exclusion
- Known or suspected pregnancy
- Age younger than 15 or less than 50kg if age unknown
- Ongoing prehospital cardiopulmonary resuscitation (CPR)
- Administration of more than 2000cc crystalloid or any colloid or blood products
- Severe hypothermia (suspected Temperature less than 28 degrees celsius)
- Drowning or asphyxia due to hanging
- Burns Total Body Surface Area (TBSA) more than 20%
- Isolated penetrating injury to the head
- Inability to obtain prehospital intravenous access
- Time of call received at dispatch to study intervention greater than four hours
- Known prisoners
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2009
Estimated Enrollment :
895 Patients enrolled
Trial Details
Trial ID
NCT00316017
Start Date
May 1 2006
End Date
August 1 2009
Last Update
March 1 2011
Active Locations (10)
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1
Alabama Resuscitaion Center, University of Alabama
Birmingham, Alabama, United States, 35249
2
UCSD-San Diego Resuscitation Research Center
San Diego, California, United States, 92103
3
Iowa Resuscitation Network, University of Iowa Carver College of Medicine
Iowa City, Iowa, United States, 52242
4
Portland Resuscitation Outcomes Consortium, Oregon Health & Sciences University
Portland, Oregon, United States, 97239