Normal Saline Versus Plasmalyte in Initial Resuscitation of Trauma Patients
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Received Date ICMJE | January 3, 2011 | ||||||||
| Last Updated Date | October 30, 2012 | ||||||||
| Start Date ICMJE | February 2011 | ||||||||
| Primary Completion Date | February 2012 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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 |
||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01270854 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
Mortality [ Time Frame: Hospital discharge ] [ Designated as safety issue: Yes ] | ||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Normal Saline Versus Plasmalyte in Initial Resuscitation of Trauma Patients | ||||||||
| Official Title ICMJE | Normal Saline Versus Plasmalyte in Initial Resuscitation of Trauma Patients | ||||||||
| 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. |
||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 2 | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
||||||||
| Condition ICMJE |
|
||||||||
| Intervention ICMJE |
|
||||||||
| Study Arm (s) |
|
||||||||
| Publications * | Not Provided | ||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||||
| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Completed | ||||||||
| Enrollment ICMJE | 46 | ||||||||
| Completion Date | April 2012 | ||||||||
| Primary Completion Date | February 2012 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||||||
| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01270854 | ||||||||
| Other Study ID Numbers ICMJE | UCDIRB-200917793 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Lynette A. Scherer, MD, FACS, University of California, Davis | ||||||||
| Study Sponsor ICMJE | University of California, Davis | ||||||||
| Collaborators ICMJE | Baxter Health Care | ||||||||
| Investigators ICMJE |
|
||||||||
| Information Provided By | University of California, Davis | ||||||||
| Verification Date | October 2012 | ||||||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||||||