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

October 19, 2021 updated by: Hospital de Clinicas de Porto Alegre

Randomized Clinical Trial to Evaluate the Effect of Water Intake on the State of Hydration and Renal Function in Elderly Patients

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Intervention:

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.

Measurements tools (applied on the first and second visits)

  • Laboratory tests: serum and urinary osmolality, sodium, urea and serum creatinine. To evaluate the effect of hydration on the glycemic control of diabetic patients, the measurement of fasting glycaemia and glycated hemoglobin (enzymatic method and HCLP) will also be performed. These dosages will be performed at the HCPA Clinical Pathology Laboratory.
  • Non-invasive test: electrical bioimpedance (BIA) InBody 370® will be used to evaluate the amount of free water, since it is simple, low cost and easy to perform in the outpatient clinics of elderly patients.
  • Nutritional assessment: the MAN questionnaire (Mini nutritional assessment) will be applied to patients selected for the study at the first and second visits. Since a valid questionnaire to evaluate only water intake was not found, the MAN questionnaire was chosen because it contains questions related to water intake and because it is easy and quick to apply.
  • MiniMental: The MiniMental cognitive function test will be applied on the first visit and after the observation period (second visit). The questionnaire is valid for the screening of cognitive disorders and it is a simple and quick method to evaluate the mental abilities of the patients under study.
  • Food record: these are sheets with space designated for filling with food and liquids and quantities consumed throughout the day. Patients are advised to make a four-day food diary out of the 14 days.

Renal function will be assessed by estimation formulas (as recommended by NKF and KDIGO) that use serum creatinine (CKD-EPI, MDRD and BIS2) and formulas that use cystatin C (CKD- EPI-cys and BIS 1).

The assessment of GFR by 51Cr-EDTA will be performed in a subgroup of 15 patients from each arm of the study in a parallel manner before and after the intervention using the 51Cr-EDTA intravenous single injection technique at a dose of 150μCi with blood samples taken at 2, 3 and 4 hours later. Samples will be centrifuged and 2 ml of plasma will be pipetted in duplicate for gamma counter counting. An exponential equation evaluates the plasma decay of 51 Cr-EDTA, providing the value of GFR .

Serum creatinine will be determined by the calibrated Jaffe method (Roche), traceable to isotopic dilution mass spectrometry (ID-MS), with kinetic reading to minimize interference by bilirubin. The dosage of cystatin C will be performed by the immunoturbidimetry method (Roche). The coefficients of intra and interassay variation are 2.2% and 5.3%, respectively.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • RS
      • Porto Alegre, RS, Brazil, 90035903
        • Hospital de Clinicas de Porto Alegre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

65 years and older (OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria: Patients are eligible if they are 65 years-old or older, attend the department of Internal Medicine and Geriatrics of Hospital de Clínicas de Porto Alegre as outpatient and accept to participate in the study.

Exclusion Criteria: Patients will be excluded if they have heart failure NYHA class III and IV, pectoris angina and/or acute myocardial infarction in the last 3 months, pacemaker or implantable cardioverter defibrillator, stage 4 or 5 chronic renal failure (GFR <30ml / min / 1.73 m²), organic or cognitive impairment that unable the patients to ingest liquids, cirrhosis, and not compensated thyroid dysfunction.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Guided water intake

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
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.
PLACEBO_COMPARATOR: Placebo - free demand water intake
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
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Renal function Improvement by CKD-EPI formula
Time Frame: 14 days
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
Time Frame: 14 days
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
Time Frame: 14 days
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Assess dehydration measuring the free corporal water
Time Frame: 14 days
Non-invasive test: electrical bioimpedance (BIA) InBody 370® will be used to evaluate the amount of free water, since it is simple, low cost and easy to perform in the outpatient clinics of elderly patients.
14 days
Assess if guided water intake can improve cognition
Time Frame: 14 days
MiniMental: The MiniMental cognitive function test will be applied on the first visit and after the observation period. The questionnaire is valid for the screening of cognitive disorders and it is a simple and quick method to evaluate the mental abilities of the patients under study.
14 days
Assess the average amount of liquids taken by patients
Time Frame: 4 days
Food record: sheets with space designated for filling with food and liquids and quantities consumed throughout the day. Patients are advised to make a four-day food diary out of the 14 days
4 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hospital de Clinicas de Porto Alegre

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Andrea Bauer, Hospital de Clinicas de Porto Alegre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2017

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2021

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 21, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 21, 2016

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 23, 2016

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 20, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 19, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 160153

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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