Chronic Kidney Disease | Impact of Increased Water Intake in Chronic Kidney Disease
Chronic Kidney Disease research study
What is the primary objective of this study?
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.
Who is eligible to participate?
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.)
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Chronic Kidney Disease
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
HydrationParticipants 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.
Start Date: April 2013
Completed Date: June 2017
Primary Outcome: Renal decline
Secondary Outcome: 24-hour urine albumin
Study sponsors, principal investigator, and references
Principal Investigator: William F Clark, MD
Lead Sponsor: Lawson Health Research Institute
Collaborator: Danone Research
Clark WF, Huang SH, Garg AX, Gallo K, House AA, Moist L, Weir MA, Sontrop JM. The Chronic Kidney Disease Water Intake Trial: Protocol of a Randomized Controlled Trial. Can J Kidney Health Dis. 2017 Aug 22;4:2054358117725106. doi: 10.1177/2054358117725106. eCollection 2017.