Evaluation of Costs and Consequences of Alternative Strategies of Intraoperative Fluid and Pharmacological Optimization. A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- number of patients with postoperative complications
研究概览
简要总结
The investigators aimed to compare the costs and consequences of 'routine perioperative fluid therapy' and 'GDHT in terms of morbidity, mortality, length of hospital stay, activity of daily living, health related quality of life, cognitive functions and need of social services and up till 12 months following operations of proximal femoral fracture at elderly. The primary hypothesis is that 'GDHT is a better strategy than 'routine fluid therapy' in terms of reduced frequency of postoperative complications.
详细描述
The investigation is an open, randomized clinical study of individuals suffering from a proximal femoral fracture. The total study duration for each subject is approximately 12 months (+- 1 month); each patient will have 4'visits' (i.e. when PI extracts data to database) including regular praxis total: at registration; at discharge; 4 months and finally at 12 months after the surgery. For practical and logistic reasons, an interim-analysis will be conducted after approximately 100 patients whose data are completed.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients (men and women) age ≥ 70 years
- •Patients´ scheduled for operation of proximal femoral fracture during office hours
- •Patient who have a witnessed or written informed consent
排除标准
- •Any of the following is regarded as a criterion for exclusion from the study:
- •Concomitant medication with Lithium
- •Known allergy (or hypersensitivity) to Lithium, or components of the medical device
- •Weight ≤ 40 kg
- •Other conditions or symptoms preventing the subject from entering the study, according to investigators judgment
- •Life expectancy less than 6 months and/or pathological fractures
- •Not possible to insert arterial line.
结局指标
主要结局
number of patients with postoperative complications
时间窗: up to 2 weeks
absolute value, number
次要结局
- health related quality of life(12 months)
- haemodynamic parameters(baseline)
- Health Related Quality of Life(1 year)
- number of complications(12 months)
研究者
Erzsebet Bartha
Medical Doctor
Karolinska Institutet