Normal Saline Versus Plasmalyte in Initial Resuscitation of Trauma Patients

Sponsor

University of California, Davis (Other)

Overall Status

Completed

CT.gov ID

NCT01270854

Collaborator

Bayer (Industry)

Enrollment

Location

Arms

Duration (Months)

3.3

Patients Per Site Per Month

Study Details

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."

Condition or Disease	Intervention/Treatment	Phase
Wounds and Injuries Multiple Trauma Disorder of Fluid Balance	Other: Plasmalyte A Other: Normal Saline	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

46 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Normal Saline Versus Plasmalyte in Initial Resuscitation of Trauma Patients

Study Start Date :

Feb 1, 2011

Actual Primary Completion Date :

Feb 1, 2012

Actual Study Completion Date :

Apr 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Plasmalyte Administration of Plasmalyte A as the standard intravenous fluid during the first 24 hours after arrival to the hospital	Other: Plasmalyte A Intravenous fluid
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 Intravenous fluid

Arm

Intervention/Treatment

Experimental: Plasmalyte

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

Other: Plasmalyte A

Intravenous fluid

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

Intravenous fluid

Outcome Measures

Primary Outcome Measures

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

Mortality [Hospital discharge]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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:

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