Chronic Kidney Disease
Conditions
Keywords
Chronic Kidney Disease, estimated glomerular filtration rate, water intake, fluid intake, renal decline
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTHydration
Sponsors
Danone Global Research & Innovation Center
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
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
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Renal decline | Baseline and 12 months | Change in estimated glomerular filtration rate between baseline and 12 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 24-hour urine albumin | Baseline and 12 months | Change in 24-hour urine albumin between baseline and 12 months |
| Rapid renal decline | Baseline and 12 months | Proportion with eGFR (estimated glomerular filtration rate) decline \>5% between baseline and 12 months |
| Measured creatinine clearance | Baseline and 12 months | Change in measured creatinine clearance between baseline and 12 months |
| Health-related quality of life | Baseline and 12 months | Change in health-related quality of life between baseline and 12 months |
| Copeptin | Baseline and 12 months | Change in copeptin between baseline and 12 months |
Other
| Measure | Time frame | Description |
|---|---|---|
| Body Mass Index | Baseline and 12 months | Change in Body Mass Index between baseline and 12 months |
| Blood pressure | Baseline and 12 months | Change in mean arterial blood pressure between baseline and 12 months |
| HbA1c | Baseline and 12 months | Change in HbA1c between between baseline and 12 months |
| Effect of fluid coaching on adherence | 12 and 24 months | Change in urine volume between 12 months and 24-months follow-up |
| Long-term renal decline | Baseline and 24 months | Change in estimated glomerular filtration rate between baseline and 24 months |
Countries
Canada
Outcome results
None listed