Normal Saline Versus Plasmalyte in Initial Resuscitation of Trauma Patients

Not Applicable

Completed

• Conditions: Multiple Trauma; Wounds and Injuries; Disorder of Fluid Balance
• Interventions: Other: Normal Saline; Other: Plasmalyte A

• Registration Number: NCT01270854
• Lead Sponsor: University of California, Davis

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.

Study Timeline

• Study First Submitted: 2011-01-03
• Study First Submitted QC: 2011-01-04
• Study First Posted: 2011-01-05
• Study Start: 2011-02
• Primary Completion: 2012-02
• Study Completion: 2012-04
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-25
• Last Update Posted: 2017-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Normal Saline	Normal Saline	Administration of Normal Saline as the standard intravenous fluid during the first 24 hours after arrival to the hospital
Plasmalyte	Plasmalyte A	Administration of Plasmalyte A as the standard intravenous fluid during the first 24 hours after arrival to the hospital

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Mortality	Hospital discharge

Trial Locations

Locations (1)

University of California, Davis, Medical Center; 🇺🇸 Sacramento, California, United States