Normal Saline Versus Plasmalyte in Initial Resuscitation of Trauma Patients

Wounds and Injuries Clinical Trial

Official title:

Normal Saline Versus Plasmalyte in Initial Resuscitation of Trauma Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01270854
• Other study ID #: 200917793
• Status: Completed
• Phase: N/A
• First received: January 3, 2011
• Last updated: May 25, 2017
• Start date: February 2011
• Est. completion date: April 2012

Study information

• Verified date: May 2017
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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."

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: April 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Other:
• Plasmalyte A
Intravenous fluid
• Normal Saline
Intravenous fluid

Locations

Country	Name	City	State
United States	University of California, Davis, Medical Center	Sacramento	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Davis	Bayer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the base deficit	Base deficit at 24 hours after randomization minus the base deficit at randomization	24 hours after randomization
Secondary	Mortality		Hospital discharge