<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03002415</url>
  </required_header>
  <id_info>
    <org_study_id>160153</org_study_id>
    <nct_id>NCT03002415</nct_id>
  </id_info>
  <brief_title>The Effect of Water Intake on the State of Hydration and Renal Function in Elderly Patients</brief_title>
  <official_title>Randomized Clinical Trial to Evaluate the Effect of Water Intake on the State of Hydration and Renal Function in Elderly Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital de Clinicas de Porto Alegre</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital de Clinicas de Porto Alegre</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Acute dehydration in the elderly is a well-known clinical condition, although situations that&#xD;
      lead to chronic dehydration in the elderly may be quite frequent, but they are poorly&#xD;
      studied. Metabolic changes in body water homeostasis can influence and provide chronic&#xD;
      dehydration status as reduced sensitivity to thirst, antidiuretic hormone and renal inability&#xD;
      to concentrate urine and the presence of chronic diseases and the use of polypharmacy may&#xD;
      also predispose states of chronic dehydration. Due to these facts, a study to detect the&#xD;
      existence of chronic dehydration states in a population of elderly people is highly&#xD;
      justifiable. In addition, understanding whether increased water intake, improving chronic&#xD;
      dehydration, may improve renal function in this population seems to be of great value, since&#xD;
      it is a simple and inexpensive intervention and, if confirmed, it can be taken to&#xD;
      institutions, by family members and health promoters who care for and cohabit with elderly&#xD;
      individuals.&#xD;
&#xD;
      Our main objective is to evaluate the effect of stimulated and calculated water intake (per&#xD;
      kg of patient weight) on the state of hydration and renal function in a population of elderly&#xD;
      individuals. It is also within the scope of this project to evaluate the presence of chronic&#xD;
      dehydration in elderly patients as well as in a subgroup of diabetic patients, and to compare&#xD;
      different methods of evaluation of renal function. Design: Clinical trial Randomized for the&#xD;
      main objective and cross-sectional study for secondary objectives.&#xD;
&#xD;
      The principal hypothesis is that guided water intake improve renal function in elderly&#xD;
      patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Intervention:&#xD;
&#xD;
      Verbal and written guidelines will be given for the patient to ingest the daily volume of&#xD;
      water calculated by the weight (30 ml / kg / day) for 14 days. Patients will receive an&#xD;
      acrylic glass with a mark in 200 ml and will be instructed to take the number of glasses a&#xD;
      day corresponding to the calculated volume (30 ml / kg). Patients will also receive a leaflet&#xD;
      indicating how many glasses of water they will need to take. They will also be instructed to&#xD;
      mark with an &quot;X&quot; the number of glasses of water that they actually drank daily during the&#xD;
      fourteen days of intervention.&#xD;
&#xD;
      Measurements tools (applied on the first and second visits)&#xD;
&#xD;
        -  Laboratory tests: serum and urinary osmolality, sodium, urea and serum creatinine. To&#xD;
           evaluate the effect of hydration on the glycemic control of diabetic patients, the&#xD;
           measurement of fasting glycaemia and glycated hemoglobin (enzymatic method and HCLP)&#xD;
           will also be performed. These dosages will be performed at the HCPA Clinical Pathology&#xD;
           Laboratory.&#xD;
&#xD;
        -  Non-invasive test: electrical bioimpedance (BIA) InBody 370® will be used to evaluate&#xD;
           the amount of free water, since it is simple, low cost and easy to perform in the&#xD;
           outpatient clinics of elderly patients.&#xD;
&#xD;
        -  Nutritional assessment: the MAN questionnaire (Mini nutritional assessment) will be&#xD;
           applied to patients selected for the study at the first and second visits. Since a valid&#xD;
           questionnaire to evaluate only water intake was not found, the MAN questionnaire was&#xD;
           chosen because it contains questions related to water intake and because it is easy and&#xD;
           quick to apply.&#xD;
&#xD;
        -  MiniMental: The MiniMental cognitive function test will be applied on the first visit&#xD;
           and after the observation period (second visit). The questionnaire is valid for the&#xD;
           screening of cognitive disorders and it is a simple and quick method to evaluate the&#xD;
           mental abilities of the patients under study.&#xD;
&#xD;
        -  Food record: these are sheets with space designated for filling with food and liquids&#xD;
           and quantities consumed throughout the day. Patients are advised to make a four-day food&#xD;
           diary out of the 14 days.&#xD;
&#xD;
      Renal function will be assessed by estimation formulas (as recommended by NKF and KDIGO) that&#xD;
      use serum creatinine (CKD-EPI, MDRD and BIS2) and formulas that use cystatin C (CKD- EPI-cys&#xD;
      and BIS 1).&#xD;
&#xD;
      The assessment of GFR by 51Cr-EDTA will be performed in a subgroup of 15 patients from each&#xD;
      arm of the study in a parallel manner before and after the intervention using the 51Cr-EDTA&#xD;
      intravenous single injection technique at a dose of 150μCi with blood samples taken at 2, 3&#xD;
      and 4 hours later. Samples will be centrifuged and 2 ml of plasma will be pipetted in&#xD;
      duplicate for gamma counter counting. An exponential equation evaluates the plasma decay of&#xD;
      51 Cr-EDTA, providing the value of GFR .&#xD;
&#xD;
      Serum creatinine will be determined by the calibrated Jaffe method (Roche), traceable to&#xD;
      isotopic dilution mass spectrometry (ID-MS), with kinetic reading to minimize interference by&#xD;
      bilirubin. The dosage of cystatin C will be performed by the immunoturbidimetry method&#xD;
      (Roche). The coefficients of intra and interassay variation are 2.2% and 5.3%, respectively.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">March 1, 2017</start_date>
  <completion_date type="Anticipated">December 2021</completion_date>
  <primary_completion_date type="Anticipated">December 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Renal function Improvement by CKD-EPI formula</measure>
    <time_frame>14 days</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Renal function Improvement by MDRD formula</measure>
    <time_frame>14 days</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Renal function Improvement by BIS-2 formula</measure>
    <time_frame>14 days</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Assess dehydration measuring the free corporal water</measure>
    <time_frame>14 days</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assess if guided water intake can improve cognition</measure>
    <time_frame>14 days</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assess the average amount of liquids taken by patients</measure>
    <time_frame>4 days</time_frame>
    <description>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</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Renal Function Disorder</condition>
  <arm_group>
    <arm_group_label>Guided water intake</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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 &quot;X&quot; the number of glasses of water that they actually drank daily during the fourteen days of intervention.&#xD;
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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo - free demand water intake</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Guided water intake</intervention_name>
    <description>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 &quot;X&quot; the number of glasses of water that they actually drank daily during the fourteen days of intervention.</description>
    <arm_group_label>Guided water intake</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo - free demand water intake</intervention_name>
    <description>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.</description>
    <arm_group_label>Placebo - free demand water intake</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria: Patients are eligible if they are 65 years-old or older, attend the&#xD;
        department of Internal Medicine and Geriatrics of Hospital de Clínicas de Porto Alegre as&#xD;
        outpatient and accept to participate in the study.&#xD;
&#xD;
        Exclusion Criteria: Patients will be excluded if they have heart failure NYHA class III and&#xD;
        IV, pectoris angina and/or acute myocardial infarction in the last 3 months, pacemaker or&#xD;
        implantable cardioverter defibrillator, stage 4 or 5 chronic renal failure (GFR &lt;30ml / min&#xD;
        / 1.73 m²), organic or cognitive impairment that unable the patients to ingest liquids,&#xD;
        cirrhosis, and not compensated thyroid dysfunction.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Andrea Bauer</last_name>
    <role>Study Director</role>
    <affiliation>Hospital de Clinicas de Porto Alegre</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital de Clínicas de Porto Alegre</name>
      <address>
        <city>Porto Alegre</city>
        <state>RS</state>
        <zip>90035903</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>December 21, 2016</study_first_submitted>
  <study_first_submitted_qc>December 21, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 23, 2016</study_first_posted>
  <last_update_submitted>October 19, 2021</last_update_submitted>
  <last_update_submitted_qc>October 19, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 20, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03002415
org study id: 160153
nct id: NCT03002415
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Renal function Improvement by CKD-EPI formula
time frame: 14 days
description: 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.
measure: Renal function Improvement by MDRD formula
time frame: 14 days
description: 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.
measure: Renal function Improvement by BIS-2 formula
time frame: 14 days
description: 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.
measure: Assess dehydration measuring the free corporal water
time frame: 14 days
description: 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.
measure: Assess if guided water intake can improve cognition
time frame: 14 days
description: 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.
measure: Assess the average amount of liquids taken by patients
time frame: 4 days
description: 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
arm group label: Guided water intake
arm group type: Experimental
description: 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.
arm group label: Placebo - free demand water intake
arm group type: Placebo Comparator
description: 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.
intervention type: Other
intervention name: Guided water intake
description: 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.
arm group label: Guided water intake
intervention type: Other
intervention name: Placebo - free demand water intake
description: 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.
arm group label: Placebo - free demand water intake
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Andrea Bauer
role: Study Director
affiliation: Hospital de Clinicas de Porto Alegre
facility: 
country: Brazil
responsible party type: Sponsor
sharing ipd: Undecided