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Clinical Trials/NCT01270854
NCT01270854
Completed
Not Applicable

Normal Saline Versus Plasmalyte in Initial Resuscitation of Trauma Patients

University of California, Davis1 site in 1 country46 target enrollmentFebruary 2011

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Wounds and Injuries
Sponsor
University of California, Davis
Enrollment
46
Locations
1
Primary Endpoint
Change in the base deficit
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

The purpose of this study is to determine whether an intravenous salt solution called "Plasmalyte" causes less abnormality of the body's acid levels than a solution called "Normal Saline."

Detailed Description

Electrolyte-containing intravenous fluids are routinely administered to patients in the first few hours after acute traumatic injury. Although Normal Saline (0.9% sodium chloride) is commonly used in this setting, it causes a hyperchloremic acidosis that may exacerbate metabolic derangements that occur after acute injury. Plasmalyte A is a solution that more closely matches physiologic electrolyte levels. In this study, we will evaluate whether Plasmalyte A results in less disturbance of the base deficit 24 hours following traumatic injury than does Normal Saline.

Registry
clinicaltrials.gov
Start Date
February 2011
End Date
April 2012
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Triaged upon arrival to the hospital as severely injured
  • At least 18 years of age
  • Meets at least one of the following criteria:
  • Intubated or likely to become intubated within 60 minutes of arrival at the hospital
  • Likely to need an operation within 60 minutes of arrival
  • Received or likely to receive a blood transfusion within 60 minutes of arrival

Exclusion Criteria

  • Greater than 60 minutes since arrival at the hospital
  • Death likely within 48 hours
  • Transfer from another hospital
  • Pre-existing renal failure requiring dialysis
  • Pregnancy
  • Prisoner status

Outcomes

Primary Outcomes

Change in the base deficit

Time Frame: 24 hours after randomization

Base deficit at 24 hours after randomization minus the base deficit at randomization

Secondary Outcomes

  • Mortality(Hospital discharge)

Study Sites (1)

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