Impact of Increased Water Intake in Chronic Kidney Disease

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized Controlled Trial of Increased Water Intake in Chronic Kidney Disease

Conditions
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Chronic Kidney Disease

Intervention / Treatment
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* Dietary Supplement: Hydration


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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.)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hydration<br>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. | Dietary Supplement: Hydration<br> <br> |
| No Intervention: Control<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Renal decline | Change in estimated glomerular filtration rate between baseline and 12 months | Baseline and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 24-hour urine albumin | Change in 24-hour urine albumin between baseline and 12 months | Baseline and 12 months | 
| Rapid renal decline | Proportion with eGFR (estimated glomerular filtration rate) decline >5% between baseline and 12 months | Baseline and 12 months | 
| Measured creatinine clearance | Change in measured creatinine clearance between baseline and 12 months | Baseline and 12 months | 
| Health-related quality of life | Change in health-related quality of life between baseline and 12 months | Baseline and 12 months | 
| Copeptin | Change in copeptin between baseline and 12 months | Baseline and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic Kidney Disease, estimated glomerular filtration rate, water intake, fluid intake, renal decline