The Chronic Kidney Disease Water Intake Trial: Protocol of a Randomized Controlled Trial
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BACKGROUND: In observational studies, drinking more water associates with a slower rate of kidney function decline; whether the same is true in a randomized controlled trial is unknown. OBJECTIVE: To examine the 1-year effect of a higher vs usual water intake on estimated glomerular filtration rate (eGFR) in patients with chronic kidney disease. DESIGN: Parallel-group randomized controlled trial. SETTING: Nine centers in Ontario, Canada. Enrollment and randomization occurred between May 2013 and May 2016; follow-up for the primary outcome will continue until June 2017. PARTICIPANTS: Adults (n = 631) with stage 3 chronic kidney disease (eGFR 30-60 mL/min/1.73 m2) and microalbuminuria. INTERVENTION: The high water intake group was coached to increase their oral water intake by 1.0 to 1.5 L/day (depending on sex and weight), over and above usual consumed beverages, for a period of 1 year. The control group was coached to maintain their usual water intake during this time. MEASURES: Participants provided 24-hour urine samples at baseline and at 6 and 12 months after randomization; urine samples were analyzed for volume, creatinine, osmolality, and the albumin-to-creatinine ratio. Blood samples were obtained at baseline and at 3- to 6-month intervals after randomization, and analyzed for creatinine, copeptin, osmolality, and electrolytes. Other measures collected included health-related quality of life, blood pressure, body mass index, and diet. PRIMARY OUTCOME: The between-group change in eGFR from baseline (prerandomization) to 12 months after randomization. SECONDARY OUTCOMES: Change in plasma copeptin concentration, 24-hour urine albumin-to-creatinine ratio, measured creatinine clearance, estimated 5-year risk of kidney failure (using the 4-variable Kidney Failure Risk Equation), and health-related quality of life. PLANNED ANALYSIS: The primary analysis will follow an intention-to-treat approach. The between-group change in eGFR will be compared using linear regression. Supplementary analyses will examine alternative definitions of eGFR change, including annual percentage change, rate of decline, and rapid decline (a P value <0.05 will be interpreted as statistically significant if there is concordance with the primary outcome). TRIAL REGISTRATION: This randomized controlled trial has been registered at www.clinicaltrials.gov; government identifier: NCT01766687.