Normal Saline Versus Plasmalyte in Initial Resuscitation of Trauma Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 2
- 主要终点
- Change in the base deficit
研究概览
简要总结
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."
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Change in the base deficit
时间窗: 24 hours after randomization
Base deficit at 24 hours after randomization minus the base deficit at randomization
次要结局
- Mortality(Hospital discharge)