A Prospective, Before and After Study of the Impact of Lower Chloride Intravenous Fluid Management on Patients' Acid-base Status, Renal Profile,Length of Stay and Mortality.
试验速览
- 阶段
- 4 期
- 入组人数
- 7,000
- 试验地点
- 1
- 主要终点
- Mean base excess during hospital stay
研究概览
简要总结
The purpose of this study is to determine whether intravenous fluid management using lower chloride solutions (Hartmann's solutions and Plasmalyte®) will result in better outcome when compared to management using high chloride solutions (0.9% saline and Gelofusine®).
详细描述
This is a prospective, controlled, before-and-after study. The baseline pre-intervention period will include collection of data while doctors and nurses are unaware that such collection is taking place. During this time, high chloride fluids (saline, Gelofusine, 4% albumin) will continue to be used according to standard practice with an estimated 30,000 liters of saline as well as 2,000 bottles of Gelofusine® being consumed.
Following a wash out period of education and preparation, there will be a complete shift to a working environment where use of saline, Gelofusine and any other fluids with a high chloride level (>110 mmol/L)will be restricted and substituted with fluids of lower chloride concentration similar to blood; either Hartmann's solution or Plasmalyte® or 20% albumin.
The study will compare a 6 month control period (before) and a six month intervention period (after).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All Intensive Care Unit (ICU) admissions at Austin Hospital
- •All Emergency Department (ED) admissions at Austin Hospital
- •All operations at Operating Theatre (OT) with hospital stay of more than 48 hours
排除标准
- 未提供
研究组 & 干预措施
Intravenous fluids
干预措施: Lower chloride fluids (Hartmann's solution and Plasmalyte®) (Drug)
结局指标
主要结局
Mean base excess during hospital stay
时间窗: Six month control period (before) and 6 month intervention period (after)
次要结局
- Unmeasured anions (strong ion gap) and chloride levels during hospital stay(Six month control period (before) and 6 month intervention period (after))
- Serum creatine levels(Six month control period (before) and 6 month intervention period (after))
- Length of ICU stay(Six month control period (before) and 6 month intervention period (after))
- Length of Emergency Department stay(Six month control period (before) and 6 month intervention period (after))
- Length of hospital stay(Six month control period (before) and 6 month intervention period (after))
- In-hospital mortality(Six month control period (before) and 6 month intervention period (after))