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The Chronic Kidney Disease Water Intake Trial: Protocol of a Randomized Controlled Trial.

ABSTRACT: 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.

SUBMITTER: Clark WF

PROVIDER: S-EPMC5571765 | biostudies-literature | 2017

REPOSITORIES: biostudies-literature

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The Chronic Kidney Disease Water Intake Trial: Protocol of a Randomized Controlled Trial.

Clark William F WF Huang Shih-Han SH Garg Amit X AX Gallo Kerri K House Andrew A AA Moist Louise L Weir Matthew A MA Sontrop Jessica M JM

Canadian journal of kidney health and disease 20170822

<h4>Background</h4>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.<h4>Objective</h4>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.<h4>Design</h4>Parallel-group randomized controlled trial.<h4>Setting</h4>Nine centers in Ontario, Canada. Enrollment and randomization occu ...[more]

PMID: 28856009

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Project description:ImportanceIn observational studies, increased water intake is associated with better kidney function.ObjectiveTo determine the effect of coaching to increase water intake on kidney function in adults with chronic kidney disease.Design, setting, and participantsThe CKD WIT (Chronic Kidney Disease Water Intake Trial) randomized clinical trial was conducted in 9 centers in Ontario, Canada, from 2013 until 2017 (last day of follow-up, May 25, 2017). Patients had stage 3 chronic kidney disease (estimated glomerular filtration rate [eGFR] 30-60 mL/min/1.73 m2 and microalbuminuria or macroalbuminuria) and a 24-hour urine volume of less than 3.0 L.InterventionsPatients in the hydration group (n = 316) were coached to drink more water, and those in the control group (n = 315) were coached to maintain usual intake.Main outcomes and measuresThe primary outcome was change in kidney function (eGFR from baseline to 12 months). Secondary outcomes included 1-year change in plasma copeptin concentration, creatinine clearance, 24-hour urine albumin, and patient-reported overall quality of health (0 [worst possible] to 10 [best possible]).ResultsOf 631 randomized patients (mean age, 65.0 years; men, 63.4%; mean eGFR, 43 mL/min/1.73 m2; median urine albumin, 123 mg/d), 12 died (hydration group [n = 5]; control group [n = 7]). Among 590 survivors with 1-year follow-up measurements (95% of 619), the mean change in 24-hour urine volume was 0.6 L per day higher in the hydration group (95% CI, 0.5 to 0.7; P < .001). The mean change in eGFR was -2.2 mL/min/1.73 m2 in the hydration group and -1.9 mL/min/1.73 m2 in the control group (adjusted between-group difference, -0.3 mL/min/1.73 m2 [95% CI, -1.8 to 1.2; P = .74]). The mean between-group differences (hydration vs control) in secondary outcomes were as follows: plasma copeptin, -2.2 pmol/L (95% CI, -3.9 to -0.5; P = .01); creatinine clearance, 3.6 mL/min/1.73 m2 (95% CI, 0.8 to 6.4; P = .01); urine albumin, 7 mg per day (95% CI, -4 to 51; P = .11); and quality of health, 0.2 points (95% CI, -0.3 to 0.3; P = .22).Conclusions and relevanceAmong adults with chronic kidney disease, coaching to increase water intake compared with coaching to maintain the same water intake did not significantly slow the decline in kidney function after 1 year. However, the study may have been underpowered to detect a clinically important difference.Trial registrationclinicaltrials.gov Identifier: NCT01766687.

Dataset Information

The Chronic Kidney Disease Water Intake Trial: Protocol of a Randomized Controlled Trial.

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The Chronic Kidney Disease Water Intake Trial: Protocol of a Randomized Controlled Trial.

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