The Water Intake Trial: Pilot Phase
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 2
- 主要终点
- 24-hour urine volume
研究概览
简要总结
The investigators are conducting a six-week randomized controlled pilot trial to assess the feasibility and safety of increased water intake in patients with chronic kidney disease.The investigators will study 30 patients (age 30 to 80 with an estimated glomerular filtration rate between 30 and 60 ml/min/1.73m2 and microalbuminuria [albumin to creatinine ratio >2.8 mg/mmol (if female) or >2.0 mg/mmol if male)].The investigators will randomize patients (in a 2:1 ratio) to a fluid-intervention group or control group. Participants who are randomized to the hydration-intervention group will be asked to consume 1.0 to 1.5 L water per day (depending on sex and weight) in addition to usual consumed beverages, for 6 weeks. Participants in the control group will be advised to consume their usual amount of fluid.
The investigators hypothesize that patients will be able to increase and maintain a higher fluid intake with stable blood chemistry, particularly serum sodium.
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
- None
入排标准
- 年龄范围
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 30-80 years
- •Able to provide informed consent and willing to complete follow-up visits.
- •Estimated glomerular filtration rate between 30 and 60 ml/min/1.73m2
- •Microalbuminuria [albumin to creatinine ratio >2.8 mg/mmol (if female) or >2.0 mg/mmol if male)]
排除标准
- •Self-reported fluid intake >10 cups/day or 24-hr urine volume >3L.
- •Enrolled in another randomized controlled trial that could influence the intervention, outcomes or data collection of this trial (or previously enrolled in this trial)
- •Received one or more dialysis treatments in the past month
- •Kidney transplant recipient (or on waiting list)
- •Pregnant or breastfeeding
- •History of kidney stones in past 5 years
- •Less than two years life expectancy
- •Serum sodium <130 mEq/L without suitable explanation
- •Serum calcium >2.6 mmol/L without suitable explanation
- •Currently taking hydrochlorothiazide >25 mg/d, indapamide >1.25 mg/d, furosemide >40 mg, or metolazone >2.5 mg/d
- •Currently taking lithium
- •Patient is under fluid restriction (< 1.5 L a day or more) for kidney disease, heart failure, or liver disease, AND meets any of the following criteria: i) end stage of the disease (heart left ventricular ejection fraction <40%, NYHA class 3 or 4, or end stage cirrhosis) or ii) hospitalization secondary to heart failure, ascites and/or anasarca
结局指标
主要结局
24-hour urine volume
时间窗: 6 weeks (baseline and six weeks)
Change in 24-hour urine volume between baseline and six weeks
次要结局
未报告次要终点
研究者
William Clark
Nephrologist
Lawson Health Research Institute