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CompletedNCT01270854Updated May 30, 2017

Normal Saline Versus Plasmalyte in Initial Resuscitation of Trauma Patients

An interventional study of Plasmalyte A and Normal Saline in Wounds and Injuries, Multiple Trauma and Disorder of Fluid Balance, sponsored by University of California, Davis. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-05-30.

Sponsored by University of California, Davis · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
46
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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."

Read the 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.

02

Conditions studied

  • Wounds and Injuries
  • Multiple Trauma
  • Disorder of Fluid Balance

Keywords

  • Normal saline
  • Plasmalyte
  • Intravenous fluid
  • Traumatic injury
  • Fluid resuscitation
03

In context

Wounds and Injuries

5,085 studies on the registry are indexed under Wounds and Injuries; 849 are open to participants now.

This study's enrollment of 46 is below the median of 52 across 3,261 interventional studies indexed under Wounds and Injuries.

Browse Wounds and Injuries studies →

Lead sponsor

University of California, Davis is the lead sponsor of 809 studies on the registry; 145 are open to participants now.

Of its 67 completed or terminated interventional studies of FDA-regulated products, 43 (64%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
46 participants (actual)

Study arms

  • Experimental
    Plasmalyte

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

    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

    Other: Normal Saline

Interventions

  • OtherPlasmalyte A

    Intravenous fluid

  • OtherNormal Saline

    Intravenous fluid

06

What researchers measure

Primary outcomes

  1. Change in the base deficit

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

    Time frame: 24 hours after randomization

Secondary outcomes

  1. Mortality

    Time frame: Hospital discharge

07

Study locations

1 site
  • University of California, Davis, Medical Center
    Sacramento, California 95817, United States
08

References and documents

Publications

  • 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. PubMed 23732264 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 30, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01270854
Collaborators
Bayer
Responsible party
Sponsor
First posted
Jan 5, 2011
Start date
Feb 2011
Primary completion
Feb 2012
Completion
Apr 2012
Last update
May 30, 2017

Study contacts

Garth H. Utter, MD
study director · University of California, Davis
Lynette A. Scherer, MD
principal investigator · University of California, Davis

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2017. You cannot join it, but the record below documents what was studied.

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