Renal Function DisorderNCT03002415
The Effect of Water Intake on the State of Hydration and Renal Function in Elderly Patients
A study testing Guided water intake in people with Renal Function Disorder, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Renal Function Disorder
- What is being tested?
- Guided water intake
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Mar 2017to Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035903
About this study
Official title: 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.
Read the 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.
- Conditions
- Renal Function Disorder
- Being tested
- Guided water intake, Placebo - free demand water intake
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guided water intakeOther
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 - free demand water intakeOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Placebo - free demand water intake |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 14 days
Secondary outcomes (3)
Assess dehydration measuring the free corporal water
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.
Measured: 14 days
Assess if guided water intake can improve cognition
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.
Measured: 14 days
Assess the average amount of liquids taken by patients
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
Measured: 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2016 (estimated)
- Study start1 Mar 2017
- Primary completionDec 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Function DisorderStudies of the same condition, open and under way.
- More trials run by Hospital de Clinicas de Porto AlegreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrea Bauer, Study director, Hospital de Clinicas de Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03002415
- Sponsor's protocol ID
- 160153
- Status last verified
- Oct 2021
- First submitted
- 21 Dec 2016
- Last updated
- 20 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial to Evaluate the Effect of Water Intake on the State of Hydration and Renal Function in Elderly Patients
- ClinicalTrials.gov ID
- NCT03002415
- Acronym / sponsor ID
- 160153
- Conditions
- Renal Function Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 23 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Guided water intake | Experimental | Other: Guided water intakeVerbal 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. |
| Placebo - free demand water intake | Placebo comparator | Other: Placebo - free demand water intakePatients 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Guided water intakeVerbal 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. | Other | Guided water intake |
| Placebo - free demand water intakePatients 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 |
Primary outcome
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.
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.
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.
3 secondary outcomes
Assess dehydration measuring the free corporal water
Time frame: 14 days
Assess if guided water intake can improve cognition
Time frame: 14 days
Assess the average amount of liquids taken by patients
Time frame: 4 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrea Bauer study director
Hospital de Clinicas de Porto Alegre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Guided water intake in people with Renal Function Disorder, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Renal function Improvement by CKD-EPI formula (time frame: 14 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2021.