Hypertonic Resuscitation Following Traumatic Injury

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 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.

Conditions

• Shock, Traumatic

Interventions

DRUG

7.5% hypertonic saline/6% Dextran-70 (HSD)

250 cc dose given as a one-time intravenous (IV) bolus in the pre-hospital setting.

DRUG

7.5% hypertonic saline (HS)

250 cc dose given as a one-time IV bolus in the pre-hospital setting.

DRUG

0.9% normal saline

250 cc dose given as a one-time IV bolus in the pre-hospital setting.

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI)

  collaborator NIH

• National Institute of Neurological Disorders and Stroke (NINDS)

  collaborator NIH

• The Institute of Circulatory and Respiratory Health (ICRH)

  collaborator UNKNOWN

• Defence Research and Development Canada

  collaborator INDUSTRY

• University of Washington

  lead OTHER

Principal Investigators

• Myron L Weisfeldt, MD · Resuscitation Outcomes Consortium

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

15 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2006-05-31

Primary Completion

2009-08-31

Completion

2009-08-31

Countries

• United States
• Canada

Study Locations