NCT02179216Unknown不适用
Evaluation of the Effect of Hydration About Orthostatic Hypotension in the Elderly. Difference With Venous Compression. A Randomized Controlled Crossover Trial.
Central Hospital, Nancy, France4 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2014年7月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 110
- 试验地点
- 4
- 主要终点
- difference in systolic blood pressure between sitting and standing at 1 and 3 minutes between hypotension test with hydration and hypotension test with venous contention
研究概览
简要总结
Primary objective: To compare the decrease in systolic blood pressure between hydration and venous contention when switching to a standing position. Hypothesis in that hydration is better than venous contention.
Secondary objective: To evaluate the effect of hydration on lowering systolic blood pressure during the passage standing in elderly patients with orthostatic hypotension.
Inclusion criteria: Patient aged over 75 years old with orthostatic hypotension proved to 1 and / or 3 min
详细描述
Day 0: confirmation of the orthostatic hypotension, without prevented measures
Two groups randomized :
- Group 1: First day (day 1), Orthostatic Hypotension test after hydration by three large glasses of clear liquid (33cl). Second day (day 2), Orthostatic Hypotension test with venous contention in the morning.
- Group 2: First day (day 1), Orthostatic Hypotension test after implementation of venous contention in the morning. Second day (day 2), Orthostatic Hypotension after hydration by three large glasses of clear liquid (33cl).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 75 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient aged 75 and older with orthostatic hypotension proved to 1 and / or 3 minutes.
- •Written consent of the subject
- •Hospitalization or stay expected minimum 3 days
- •Affiliation to a social security scheme
排除标准
- •bedridden patient or without possibility of verticalization
- •Patient who can't stand up (pulmonary embolism with high risk)
- •Patient who refuse to participate in the study
- •Patient with legal protection
- •State or condition that may affect the stability of blood pressure during the study (hyperthermia, modification antihypertensive treatments less than 48 hours before inclusion...)
- •Pathology preventing hydration: Heart failure with less than 1 Liter water restriction, swallowing disorders preventing hydration orally, inability to nutrition and hydration orally
- •Intravenous or subcutaneous hydration (intravenous or subcutaneous treatments not included)
- •Patient who can't have venous contention: Blue phlebitis, septic thrombosis, arteritis with score less than 0.6, varicose ulcers during treatment
结局指标
主要结局
difference in systolic blood pressure between sitting and standing at 1 and 3 minutes between hypotension test with hydration and hypotension test with venous contention
时间窗: during 3 days: day 0, day 1, day 2
次要结局
- difference in systolic blood pressure between sitting and standing at 1 and 3 minutes between hypotension test with hydration and hypotension test without prevention(during 3 days: at day 0, day 1, day 2)
研究者
研究点 (4)
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