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Normal Saline Versus Plasmalyte in Initial Resuscitation of Trauma Patients

This study has been completed.
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
Lynette A. Scherer, MD, FACS, University of California, Davis
ClinicalTrials.gov Identifier:
NCT01270854
First received: January 3, 2011
Last updated: October 30, 2012
Last verified: October 2012

January 3, 2011
October 30, 2012
February 2011
February 2012   (final data collection date for primary outcome measure)
Change in the base deficit [ Time Frame: 24 hours after randomization ] [ Designated as safety issue: Yes ]
Base deficit at 24 hours after randomization minus the base deficit at randomization
Same as current
Complete list of historical versions of study NCT01270854 on ClinicalTrials.gov Archive Site
Mortality [ Time Frame: Hospital discharge ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Normal Saline Versus Plasmalyte in Initial Resuscitation of Trauma Patients
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."

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Wounds and Injuries
  • Multiple Trauma
  • Disorder of Fluid Balance
  • Other: Plasmalyte A
    Intravenous fluid
  • Other: Normal Saline
    Intravenous fluid
  • Experimental: Plasmalyte
    Administration of Plasmalyte A as the standard intravenous fluid during the first 24 hours after arrival to the hospital
    Intervention: Other: Plasmalyte A
  • Active Comparator: Normal Saline
    Administration of Normal Saline as the standard intravenous fluid during the first 24 hours after arrival to the hospital
    Intervention: Other: Normal Saline
Young JB, Utter GH, Schermer CR, Galante JM, Phan HH, Yang Y, Anderson BA, Scherer LA. Saline versus Plasma-Lyte A in initial resuscitation of trauma patients: a randomized trial. Ann Surg. 2014 Feb;259(2):255-62. doi: 10.1097/SLA.0b013e318295feba.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
46
April 2012
February 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01270854
UCDIRB-200917793
No
Lynette A. Scherer, MD, FACS, University of California, Davis
University of California, Davis
Bayer
Study Director: Garth H. Utter, MD University of California, Davis
Principal Investigator: Lynette A. Scherer, MD University of California, Davis
University of California, Davis
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP