Normal Saline Versus Plasmalyte in Initial Resuscitation of Trauma Patients
1 other identifier
interventional
46
1 country
1
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."
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 3, 2011
CompletedFirst Posted
Study publicly available on registry
January 5, 2011
CompletedStudy Start
First participant enrolled
February 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2012
CompletedMay 30, 2017
May 1, 2017
1 year
January 3, 2011
May 25, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in the base deficit
Base deficit at 24 hours after randomization minus the base deficit at randomization
24 hours after randomization
Secondary Outcomes (1)
Mortality
Hospital discharge
Study Arms (2)
Plasmalyte
EXPERIMENTALAdministration of Plasmalyte A as the standard intravenous fluid during the first 24 hours after arrival to the hospital
Normal Saline
ACTIVE COMPARATORAdministration of Normal Saline as the standard intravenous fluid during the first 24 hours after arrival to the hospital
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of California, Davislead
- Bayercollaborator
Study Sites (1)
University of California, Davis, Medical Center
Sacramento, California, 95817, United States
Related Publications (1)
Young JB, Utter GH, Schermer CR, Galante JM, Phan HH, Yang Y, Anderson BA, Scherer LA. Saline versus Plasma-Lyte A in initial resuscitation of trauma patients: a randomized trial. Ann Surg. 2014 Feb;259(2):255-62. doi: 10.1097/SLA.0b013e318295feba.
PMID: 23732264DERIVED
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Garth H. Utter, MD
University of California, Davis
- PRINCIPAL INVESTIGATOR
Lynette A. Scherer, MD
University of California, Davis
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 3, 2011
First Posted
January 5, 2011
Study Start
February 1, 2011
Primary Completion
February 1, 2012
Study Completion
April 1, 2012
Last Updated
May 30, 2017
Record last verified: 2017-05