NCT00113685

Brief Summary

The purpose of this study is to evaluate the clinical outcome of patients following blunt traumatic injury with hypovolemic shock, who receive either lactated ringer's solution or hypertonic saline with dextran (HSD) resuscitation; also, to focus specifically on neurologic outcome in patients with brain injury and on the effect of HSD resuscitation on inflammatory cell responsiveness.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
209

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2003

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2003

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

June 9, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 10, 2005

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed
Last Updated

May 3, 2021

Status Verified

April 1, 2021

First QC Date

June 9, 2005

Last Update Submit

April 28, 2021

Conditions

Respiratory Distress Syndrome, AdultHead Injuries, ClosedShockShock, Traumatic

Outcome Measures

Primary Outcomes (1)

  • Adult respiratory distress syndrome symptoms (measured 28 days post-injury)

Secondary Outcomes (6)

  • Multiple organ failure syndrome

  • 28 day mortality

  • Nosocomial infections

  • Duration of hospital and ICU stay

  • Duration of mechanical ventilation

  • +1 more secondary outcomes

Interventions

Hypertonic Saline-Dextran SolutionDRUG
Lactated Ringer's SolutionDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Recent blunt trauma
  • Of adult size if age is unknown
  • Pre-hospital systolic bloood pressure 90 mm Hg or less
  • Altered mental status
  • Transported directly to Harborview Medical Center from the injury event

You may not qualify if:

  • Ongoing CPR
  • Transferred from outside hospitals
  • Pregnant or suspected pregnancy
  • Presence of injuries from penetrating trauma
  • Receiving more than 2000 cc of crystaloid prior to study fluid administration

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Washington

Seattle, Washington, 98104-2499, United States

Location

Related Publications (1)

  • Bulger EM, Jurkovich GJ, Nathens AB, Copass MK, Hanson S, Cooper C, Liu PY, Neff M, Awan AB, Warner K, Maier RV. Hypertonic resuscitation of hypovolemic shock after blunt trauma: a randomized controlled trial. Arch Surg. 2008 Feb;143(2):139-48; discussion 149. doi: 10.1001/archsurg.2007.41.

    PMID: 18283138DERIVED

MeSH Terms

Conditions

Respiratory Distress SyndromeHead Injuries, ClosedShockShock, Traumatic

Interventions

hypertonic saline-dextran solutionRinger's Lactate

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration DisordersCraniocerebral TraumaTrauma, Nervous SystemNervous System DiseasesWounds and InjuriesWounds, NonpenetratingPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Eileen Bulger

    University of Washington

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, School of Medicine

Study Record Dates

First Submitted

June 9, 2005

First Posted

June 10, 2005

Study Start

April 1, 2003

Study Completion

March 1, 2007

Last Updated

May 3, 2021

Record last verified: 2021-04

Locations

US(1)