Normal Saline Versus Plasmalyte in Initial Resuscitation of Trauma Patients

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01270854

Enrollment

Registered

2011-01-05

Start date

2011-02-28

Completion date

2012-04-30

Last updated

2017-05-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Disorder of Fluid Balance, Multiple Trauma, Wounds and Injuries

Keywords

Normal saline, Plasmalyte, Intravenous fluid, Traumatic injury, Fluid resuscitation

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.

Interventions

OTHERPlasmalyte A

Intravenous fluid

OTHERNormal Saline

Intravenous fluid

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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: 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

Design outcomes

Primary

Measure	Time frame	Description
Change in the base deficit	24 hours after randomization	Base deficit at 24 hours after randomization minus the base deficit at randomization

Secondary

Measure	Time frame
Mortality	Hospital discharge

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 10, 2026