Normal Saline Versus Plasmalyte in Initial Resuscitation of Trauma Patients

Brief Summary

Official Title: “Normal Saline Versus Plasmalyte in Initial Resuscitation of Trauma Patients”

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."

  • Study Type: Interventional
  • Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
  • Study Primary Completion Date: February 2012

Detailed Clinical Trial 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.

Interventions Used in this Clinical Trial

  • Other: Plasmalyte A
    • Intravenous fluid
  • Other: Normal Saline
    • Intravenous fluid

Arms, Groups and Cohorts in this Clinical Trial

  • Experimental: Plasmalyte
    • Administration of Plasmalyte A as the standard intravenous fluid during the first 24 hours after arrival to the hospital
  • Active Comparator: Normal Saline
    • Administration of Normal Saline as the standard intravenous fluid during the first 24 hours after arrival to the hospital

Outcome Measures for this Clinical Trial

Primary Measures

  • Change in the base deficit
    • Time Frame: 24 hours after randomization
      Safety Issue?: Yes

Secondary Measures

  • Mortality
    • Time Frame: Hospital discharge
      Safety Issue?: Yes

Criteria for Participation in this Clinical Trial

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:

1. Intubated or likely to become intubated within 60 minutes of arrival at the hospital

2. Likely to need an operation within 60 minutes of arrival

3. 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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial: No

Clinical Trial Investigator Information

  • Lead Sponsor
    • University of California, Davis
  • Collaborator
    • Bayer
  • Provider of Information About this Clinical Study
    • Principal Investigator: Lynette A. Scherer, MD, FACS, Associate Professor – University of California, Davis
  • Overall Official(s)
    • Garth H. Utter, MD, Study Director, University of California, Davis
    • Lynette A. Scherer, MD, Principal Investigator, University of California, Davis

Source

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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT01270854