Normal Saline Versus Plasmalyte in Initial Resuscitation of Trauma Patients

University of California (UC) Davis

Status: Completed

Conditions: Disorder of Fluid Balance; Multiple Trauma; Wounds and Injuries

Treatments: Other: Normal Saline; Other: Plasmalyte A

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01270854

200917793

Details and patient eligibility

About

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."

Full 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.

Enrollment: 46 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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46 participants in 2 patient groups

Plasmalyte

Experimental group

Description:

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

Treatment:

Other: Plasmalyte A

Normal Saline

Active Comparator group

Description:

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

Treatment:

Other: Normal Saline