Normal Saline Versus Plasmalyte in Initial Resuscitation of Trauma Patients

This study has been completed.
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
Lynette A. Scherer, MD, FACS, University of California, Davis
ClinicalTrials.gov Identifier:
NCT01270854
First received: January 3, 2011
Last updated: October 30, 2012
Last verified: October 2012
  Purpose

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 Intervention Phase
Wounds and Injuries
Multiple Trauma
Disorder of Fluid Balance
Other: Plasmalyte A
Other: Normal Saline
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Normal Saline Versus Plasmalyte in Initial Resuscitation of Trauma Patients

Resource links provided by NLM:


Further study details as provided by University of California, Davis:

Primary Outcome Measures:
  • Change in the base deficit [ Time Frame: 24 hours after randomization ] [ Designated as safety issue: Yes ]
    Base deficit at 24 hours after randomization minus the base deficit at randomization


Secondary Outcome Measures:
  • Mortality [ Time Frame: Hospital discharge ] [ Designated as safety issue: Yes ]

Enrollment: 46
Study Start Date: February 2011
Study Completion Date: April 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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:

    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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01270854

Locations
United States, California
University of California, Davis, Medical Center
Sacramento, California, United States, 95817
Sponsors and Collaborators
University of California, Davis
Bayer
Investigators
Study Director: Garth H. Utter, MD University of California, Davis
Principal Investigator: Lynette A. Scherer, MD University of California, Davis
  More Information

No publications provided by University of California, Davis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Lynette A. Scherer, MD, FACS, Associate Professor, University of California, Davis
ClinicalTrials.gov Identifier: NCT01270854     History of Changes
Other Study ID Numbers: UCDIRB-200917793
Study First Received: January 3, 2011
Last Updated: October 30, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Davis:
Normal saline
Plasmalyte
Intravenous fluid
Traumatic injury
Fluid resuscitation

Additional relevant MeSH terms:
Wounds and Injuries
Multiple Trauma
Plasma-lyte 148
Ophthalmic Solutions
Pharmaceutical Solutions
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014