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OpenTrials
Completed

NCT Number: NCT01270854

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."

Completed

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California, Davis, Medical Center

Sacramento, California, 95817, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Plasmalyte A

Other

Intravenous fluid

Normal Saline

Other

Intravenous fluid

Primary outcomes

  1. 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

  1. Mortality

    Time frame: Hospital discharge

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Collaborators

  • Bayer

Registry information

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jan 5, 2011
Registry last updated
May 30, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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