Normal Saline Versus Plasmalyte in Initial Resuscitation of Trauma Patients
This study has been completed.
Sponsor:
University of California, Davis
Collaborator:
Baxter Health Care
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
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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:
- 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
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
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
Baxter Health Care
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
| 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:
|
Multiple Trauma Wounds and Injuries |
ClinicalTrials.gov processed this record on June 18, 2013