The Effect of Water Intake on the State of Hydration and Renal Function in Elderly Patients

NCT03002415 | Unknown

• 1 other identifier: 160153
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Acute dehydration in the elderly is a well-known clinical condition, although situations that lead to chronic dehydration in the elderly may be quite frequent, but they are poorly studied. Metabolic changes in body water homeostasis can influence and provide chronic dehydration status as reduced sensitivity to thirst, antidiuretic hormone and renal inability to concentrate urine and the presence of chronic diseases and the use of polypharmacy may also predispose states of chronic dehydration. Due to these facts, a study to detect the existence of chronic dehydration states in a population of elderly people is highly justifiable. In addition, understanding whether increased water intake, improving chronic dehydration, may improve renal function in this population seems to be of great value, since it is a simple and inexpensive intervention and, if confirmed, it can be taken to institutions, by family members and health promoters who care for and cohabit with elderly individuals. Our main objective is to evaluate the effect of stimulated and calculated water intake (per kg of patient weight) on the state of hydration and renal function in a population of elderly individuals. It is also within the scope of this project to evaluate the presence of chronic dehydration in elderly patients as well as in a subgroup of diabetic patients, and to compare different methods of evaluation of renal function. Design: Clinical trial Randomized for the main objective and cross-sectional study for secondary objectives. The principal hypothesis is that guided water intake improve renal function in elderly patients.

Conditions

Renal Function Disorder

Outcome Measures

Primary Outcomes (3)

• Renal function Improvement by CKD-EPI formula

  Renal function will be assess before and after 14 days of guided water intake on the intervention group and control group. CKD-EPI is a formula that considers serum creatinine, age, gender and race to estimate glomerular filtration rate.

  14 days

• Renal function Improvement by MDRD formula

  Renal function will be assess before and after 14 days of guided water intake on the intervention group and control group. MDRD is a formula that considers serum creatinine, age, gender and race to estimate glomerular filtration rate.

  14 days

• Renal function Improvement by BIS-2 formula

  Renal function will be assess before and after 14 days of guided water intake on the intervention group and control group. BIS-2 is a formula that considers serum creatinine and cystatin-C to estimate glomerular filtration rate.

  14 days

Secondary Outcomes (3)

• Assess dehydration measuring the free corporal water

  14 days

• Assess if guided water intake can improve cognition

  14 days

• Assess the average amount of liquids taken by patients

  4 days

Study Arms (2)

Guided water intake

EXPERIMENTAL

Verbal and written guidelines will be given for the patient to ingest the daily volume of water calculated by the weight (30 ml / kg / day) for 14 days. Patients will receive an acrylic glass with a mark in 200 ml and will be instructed to take the number of glasses a day corresponding to the calculated volume (30 ml / kg). Patients will also receive a leaflet indicating how many glasses of water they will need to take. They will also be instructed to mark with an "X" the number of glasses of water that they actually drank daily during the fourteen days of intervention. Patients are asked to note on a food record food and liquids and quantities consumed throughout the day. Patients are advised to make a four-day food diary out of the 14 days.

Other: Guided water intake

Placebo - free demand water intake

PLACEBO COMPARATOR

Patients are instructed to drink water and other liquids on demand. Patients are asked to note on a food record food and liquids and quantities consumed throughout the day. Patients are advised to make a four-day food diary out of the 14 days.

Other: Placebo - free demand water intake

Interventions

Guided water intake OTHER

Verbal and written guidelines will be given for the patient to ingest the daily volume of water calculated by the weight (30 ml / kg / day) for 14 days. Patients will receive an acrylic glass with a mark in 200 ml and will be instructed to take the number of glasses a day corresponding to the calculated volume (30 ml / kg). Patients will also receive a leaflet indicating how many glasses of water they will need to take. They will also be instructed to mark with an "X" the number of glasses of water that they actually drank daily during the fourteen days of intervention.

Guided water intake

Placebo - free demand water intake OTHER

Patients are instructed to drink water and other liquids on demand. Patients are asked to note on a food record food and liquids and quantities consumed throughout the day. Patients are advised to make a four-day food diary out of the 14 days.

Placebo - free demand water intake

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead

Study Sites (1)

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035903, Brazil

Location

Study Officials

• Andrea Bauer

  Hospital de Clinicas de Porto Alegre

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2016
• First Posted: December 23, 2016
• Study Start: March 1, 2017
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: October 20, 2021

Record last verified: 2021-10

Locations

BR (1)