Hypertonic Resuscitation Following Traumatic Injury

Stopped early · Phase 3

Conditions studied: Shock, Traumatic

In brief

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 body to be in shock (low blood pressure related to blood loss). This decreased blood flow can lead to organ damage. In order to restore the blood pressure and blood flow, the medics give fluids into the patients' veins as soon as possible. This is called "resuscitation." The resuscitation fluid most commonly used is "isotonic" or one that is the same concentration as the blood. The investigators are trying to determine if infusing a "hypertonic" fluid (or one more concentrated than the blood) can increase the blood pressure and restore blood flow more efficiently. The hypertonic fluids the investigators are using are called hypertonic saline with dextran (HSD) and hypertonic saline (no dextran). Hypertonic saline is a salt solution that is slightly more concentrated than your blood. Dextran is a sugar solution.

Key facts

Study ID

NCT00316017

Run by

University of Washington

People needed

895

Starts

2006-05-01

Expected to finish

2009-08-01

Last updated by the study team

2011-03-01

Who can join

Age: 15 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Alabama Resuscitaion Center, University of Alabama — Birmingham, Alabama, United States
• UCSD-San Diego Resuscitation Research Center — San Diego, California, United States
• Iowa Resuscitation Network, University of Iowa Carver College of Medicine — Iowa City, Iowa, United States
• Portland Resuscitation Outcomes Consortium, Oregon Health & Sciences University — Portland, Oregon, United States
• The Pittsburgh Resuscitation Network, University of Pittsburgh — Pittsburgh, Pennsylvania, United States
• Dallas Center for Resuscitation Research, University of Texas Southwestern Medical Center — Dallas, Texas, United States
• Seattle-King County Center For Resuscitation Research, University of Washington — Seattle, Washington, United States
• Milwaukee Resuscitation Network, Medical College of Wisconsin — Milwaukee, Wisconsin, United States
• University of Ottawa/University of British Columbia Collaborative RCC, Ottawa Health Research Institute — Ottawa, Ontario, Canada
• Toronto Regional Resuscitation Research Out-of-Hospital Network, University of Toronto — Toronto, Ontario, Canada

Full record on ClinicalTrials.gov

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