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Normal Saline Versus Plasmalyte in Initial Resuscitation of Trauma Patients

Primary Purpose

Wounds and Injuries, Multiple Trauma, Disorder of Fluid Balance

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Plasmalyte A
Normal Saline
Sponsored by
University of California, Davis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Wounds and Injuries focused on measuring Normal saline, Plasmalyte, Intravenous fluid, Traumatic injury, Fluid resuscitation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of California, Davis, Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Plasmalyte

Normal Saline

Arm Description

Administration of Plasmalyte A as the standard intravenous fluid during the first 24 hours after arrival to the hospital

Administration of Normal Saline as the standard intravenous fluid during the first 24 hours after arrival to the hospital

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Mortality

Full Information

First Posted
January 3, 2011
Last Updated
May 25, 2017
Sponsor
University of California, Davis
Collaborators
Bayer
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1. Study Identification

Unique Protocol Identification Number
NCT01270854
Brief Title
Normal Saline Versus Plasmalyte in Initial Resuscitation of Trauma Patients
Official Title
Normal Saline Versus Plasmalyte in Initial Resuscitation of Trauma Patients
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
April 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Davis
Collaborators
Bayer

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wounds and Injuries, Multiple Trauma, Disorder of Fluid Balance
Keywords
Normal saline, Plasmalyte, Intravenous fluid, Traumatic injury, Fluid resuscitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Plasmalyte
Arm Type
Experimental
Arm Description
Administration of Plasmalyte A as the standard intravenous fluid during the first 24 hours after arrival to the hospital
Arm Title
Normal Saline
Arm Type
Active Comparator
Arm Description
Administration of Normal Saline as the standard intravenous fluid during the first 24 hours after arrival to the hospital
Intervention Type
Other
Intervention Name(s)
Plasmalyte A
Intervention Description
Intravenous fluid
Intervention Type
Other
Intervention Name(s)
Normal Saline
Intervention Description
Intravenous fluid
Primary Outcome Measure Information:
Title
Change in the base deficit
Description
Base deficit at 24 hours after randomization minus the base deficit at randomization
Time Frame
24 hours after randomization
Secondary Outcome Measure Information:
Title
Mortality
Time Frame
Hospital discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Garth H. Utter, MD
Organizational Affiliation
University of California, Davis
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Lynette A. Scherer, MD
Organizational Affiliation
University of California, Davis
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, Davis, Medical Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
23732264
Citation
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.
Results Reference
derived

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Normal Saline Versus Plasmalyte in Initial Resuscitation of Trauma Patients

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