A Randomized Controlled Trial of Increased Water Intake in Chronic Kidney Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 822
- 试验地点
- 2
- 主要终点
- Renal decline
研究概览
简要总结
The investigators have designed a randomized controlled trial to test whether increased water intake slows renal decline in patients with Stage-III Chronic Kidney Disease. Participants randomized to the hydration-intervention group will be asked to drink 1.0 to 1.5 L of water per day (depending on sex and weight), in addition to usual fluid intake, for one year. The investigators will calculate the change in kidney function (estimated glomerular filtration rate, measured every three months for 12 months), and compare renal decline between the intervention and control groups. The investigators hypothesize that increased water intake will slow renal decline.
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
- Single (Outcomes Assessor)
盲法说明
Research staff and participants were aware of the randomized group assignment; however, outcome assessors (technicians performing the laboratory measurements for the primary and secondary outcomes) are blinded to the random allocation, and the trial statistician will be blinded to patient allocation for the primary analysis
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-80 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
- •Trace protein or greater (Albustix) or urine albumin/creatinine ratio >2.8 mg/mmol (if female) or >2.0 mg/mmol (if male) from a random spot urine sample
排除标准
- •Self-reported fluid intake >10 cups/day or 24-hr urine volume >3L.
- •Enrolled in another 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 within past six months (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) 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
- •Patient has GI disease (history of inflammatory bowel disease, Crohns, etc.)
研究组 & 干预措施
Hydration
Participants randomized to the hydration-intervention group will be asked to drink 1.0 to 1.5 L of water per day (depending on sex and weight), in addition to usual consumed beverages, for 12 months.
干预措施: Hydration (Dietary Supplement)
Control
结局指标
主要结局
Renal decline
时间窗: Baseline and 12 months
Change in estimated glomerular filtration rate between baseline and 12 months
次要结局
- Rapid renal decline(Baseline and 12 months)
- Copeptin(Baseline and 12 months)
- 24-hour urine albumin(Baseline and 12 months)
- Measured creatinine clearance(Baseline and 12 months)
- Health-related quality of life(Baseline and 12 months)
研究者
William Clark
Principle Investigator
Lawson Health Research Institute