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| Name | Class |
|---|---|
| Bayer | INDUSTRY |
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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."
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Plasmalyte | Experimental | Administration of Plasmalyte A as the standard intravenous fluid during the first 24 hours after arrival to the hospital |
|
| Normal Saline | Active Comparator | Administration of Normal Saline as the standard intravenous fluid during the first 24 hours after arrival to the hospital |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Plasmalyte A | Other | Intravenous fluid |
| |
| Normal Saline |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the base deficit | Base deficit at 24 hours after randomization minus the base deficit at randomization | 24 hours after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality | Hospital discharge |
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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:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Garth H. Utter, MD | University of California, Davis | Study Director |
| Lynette A. Scherer, MD | University of California, Davis | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, Davis, Medical Center | Sacramento | California | 95817 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23732264 | Derived | 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. |
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| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D009104 | Multiple Trauma |
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| ID | Term |
|---|---|
| C048013 | Plasmalyte A |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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| Other |
Intravenous fluid |
|