Normal Saline Versus Plasmalyte in Initial Resuscitation of Trauma Patients

Study Overview
=================
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.

Official Title
-----------------
Normal Saline Versus Plasmalyte in Initial Resuscitation of Trauma Patients

Conditions
-----------------
Wounds and Injuries, Multiple Trauma, Disorder of Fluid Balance

Intervention / Treatment
-----------------
* Other: Plasmalyte A
* Other: Normal Saline


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Plasmalyte<br>Administration of Plasmalyte A as the standard intravenous fluid during the first 24 hours after arrival to the hospital | Other: Plasmalyte A<br>* Intravenous fluid<br>|
| Active Comparator: Normal Saline<br>Administration of Normal Saline as the standard intravenous fluid during the first 24 hours after arrival to the hospital | Other: Normal Saline<br>* Intravenous fluid<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the base deficit | Base deficit at 24 hours after randomization minus the base deficit at randomization | 24 hours after randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality |  | Hospital discharge | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Normal saline, Plasmalyte, Intravenous fluid, Traumatic injury, Fluid resuscitation