Coffee Intake in HemoDialysis and Headache (CoffeeHD): a Randomized Double Blind Multicenter Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 156
- 试验地点
- 1
- 主要终点
- number of headache episodes
研究概览
简要总结
Coffee is the most consumed drink worldwide, sometimes needed to boost energy and other times to entertain social connectivity. Caffeine is mostly present unbound in the plasma, only 10 to 30% of caffeine binds to plasma proteins. It is distributed freely into the intracellular space, and it has a small distribution volume. Therefore, caffeine can pass through the dialysis membrane during a standard hemodialysis session. In hemodialysis patients, headache occurs in 40 to 75% of patients. Some authors have suggested that one of the reasons of headache during hemodialysis is caffeine withdrawal. This trial aims to find whether coffee intake during hemodialysis reduces the headache episodes. It is a randomized double blind multicenter trial where 160 patients will be randomized to 2 groups: group 1 of 80 patients will be given a cup of coffee each dialysis session for 4 weeks and group 2 will receive decaffeinated coffee each dialysis session for 4 weeks.
详细描述
Coffee is the most consumed drink worldwide, sometimes needed to boost energy and other times to entertain social connectivity. It is known also to cause addiction and thus be a cause for withdrawal symptoms such as headache and irritability. Coffee is not contra-indicated in patients with chronic kidney disease. Caffeine is mostly present unbound in the plasma, only 10 to 30% of caffeine binds to plasma proteins. It is distributed freely into the intracellular space, and it has a small distribution volume within the body around 0,7L/kg. Therefore, caffeine can pass through the dialysis membrane during a standard hemodialysis session. In hemodialysis patients, intra-dialytic hypotension, fatigue post-dialysis and headache occur in 40 to 75% of patients. Some authors have suggested that one of the reasons of headache during hemodialysis is caffeine withdrawal.
This trial aims to find out whether coffee consumption during dialysis could decrease headache episodes.
Methods
Study setting All patients on chronic hemodialysis in three Lebanese dialysis units, Saint-Georges Ajaltoun hospital, Hôtel-Dieu de France and Bellevue Medical Center will be included.
Trial design and participants This is a randomized, controlled, double-blind, multi-center clinical trial. Patients will be randomized to one of two arms and then group one will receive the coffee during hemodialysis session and group two will receive decaffeinated coffee.
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)
盲法说明
Blinding will be ensured by an outsider who will hold the coffee cups to nurses with the name of patients on the cups
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All adult patients > 18 years old on chronic hemodialysis
排除标准
- •patients with a history of chronic or paroxysmal atrial fibrillation
- •patients on chronic systematic pain killers
- •patients with a problem of swallowing food or drinks
- •patients who are coffee allergic or intolerant.
结局指标
主要结局
number of headache episodes
时间窗: 4 weeks
number of headache episodes during or immediately after dialysis over 12
次要结局
- irritability(4 weeks)
- number of intra-dialytic hypotensive episodes(4 weeks)
- number of sleeping hours per night(4 weeks)
- energy after dialysis(4 weeks)
研究者
Mabel Aoun
Dr
Saint-Joseph University