Normal Saline Versus Plasmalyte in Initial Resuscitation of Trauma Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2012-04-30

Brief Summary

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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."

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Detailed Description

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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.

Conditions

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Wounds and Injuries Multiple Trauma Disorder of Fluid Balance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Plasmalyte

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

Group Type EXPERIMENTAL

Plasmalyte A

Intervention Type OTHER

Intravenous fluid

Normal Saline

Administration of Normal Saline as the standard intravenous fluid during the first 24 hours after arrival to the hospital

Group Type ACTIVE_COMPARATOR

Normal Saline

Intervention Type OTHER

Intravenous fluid

Interventions

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Plasmalyte A

Intravenous fluid

Intervention Type OTHER

Normal Saline

Intravenous fluid

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No