Dehydration HypertonicNCT03596580
Validation of a Screening Tool to Assess Dehydration in Hospitalized Older Population
An observational study of Dehydration Hypertonic and Aged, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 1 site in Italy.
Trial summary
The study aims to verify the sensitivity and specificity of a tool to assess the state of hydration of the older person to identify those at risk of dehydration. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Dehydration Hypertonic, Aged
- How many people
- 222 participants
- Where
- 1 siteItaly
- Study dates
- 23 Jul 2018to Jun 2019
- Phase
- Observational
- 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
- No healthy volunteers
- Older adult
Study population: The study will concern people aged 65 or over, admitted to the medical departments of the Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico. Critical, pediatric and psychiatric areas are excluded.
Who may be able to join
- Complete blood tests: Urea, Glucose, Sodium, Potassium reported not more than 24 hours before the observation;
- Absence of known cognitive impairments (Mini-Mental State Examination > 24).
Who cannot join
- Age < 65;
- Mini-Mental State Examination < 24.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Fondazione Ca' Granda Ospedale Maggiore Policlinico
Milan, 20122
Ivana Maria Rosi, Dr, +390255035457, ivana.rosi@policlinico.mi.it
Roberto Milos, Dr, +390255032704, roberto.milos@policlinico.mi.it
About this study
Official title: Clinical Validation of a Screening Tool to Assess Dehydration in Older Population
The study aims to verify the sensitivity and specificity of a tool to assess the state of hydration of the older person to identify those at risk of dehydration.
Read the detailed description
Dehydration is the result of insufficient fluid intake and can be consequent to an alteration of thirst mechanisms or fluid loss from the intestinal and respiratory tracts. The use of diuretics can lead to dehydration too. The risk of dehydration induced by acute or chronical diseases is increased in older people because of the reduced capacity to maintain a proper fluid balance. Lower muscle mass, reduced kidney function, physical and cognitive disabilities, blunted thirst, and polytherapy are recognized as main factors for dehydration risk in older people.For these reasons, coordinated efforts are necessary to develop comprehensive assessment tool to monitor hydration in hospitalised older adults. We need to develop a pathway of screening to detect early stage dehydration in older patients in order to correct it precociously. Presently, no standardized clinical dehydration assessment method exists and there are relatively few papers investigating hydration status. A new tool was created: the Geriatric Dehydration Screening Tool - Modified doesn't require laboratory parameters, and thus its use is feasible outside hospital settings. The aim of this study is to evaluate the diagnostic accuracy of the Geriatric Dehydration Screening Tool - Modified in the assessment of the hydration status of hospitalized older population.
- Conditions
- Dehydration Hypertonic, Aged
- Keywords
- Screening tool
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Dehydrated participants | 125 participants ≥ 65 years of age at the moment of the interviews; hospitalized in General Medicine; osmolarity ≥ 296 mOsm/L | |
| Hydrated participants | 97 participants ≥ 65 years of age at the moment of the interviews; hospitalized in General Medicine; osmolarity < 296 mOsm/L |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy
The diagnostic accuracy of Geriatric Dehydration Screening Tool-Modified in detecting dehydrated older people, compared to the standard reference (serum osmolarity)
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2018
- Study start23 Jul 2018
- Primary completionJun 2019 (estimated)
- Study completionJun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Dehydration HypertonicStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoThe 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 222 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03596580
- Sponsor's protocol ID
- GDST-M
- Status last verified
- Feb 2019
- First submitted
- 12 Jul 2018
- Last updated
- 22 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Vivanti A, Harvey K, Ash S. Developing a quick and practical screen to improve the identification of poor hydration in geriatric and rehabilitative care. Arch Gerontol Geriatr. 2010 Mar-Apr;50(2):156-64. doi: 10.1016/j.archger.2009.03.003. Epub 2009 Apr 23.
PubMed 19395070Rodrigues S, Silva J, Severo M, Inacio C, Padrao P, Lopes C, Carvalho J, do Carmo I, Moreira P. Validation analysis of a geriatric dehydration screening tool in community-dwelling and institutionalized elderly people. Int J Environ Res Public Health. 2015 Mar 2;12(3):2700-17. doi: 10.3390/ijerph120302700.
PubMed 25739005Hooper L, Abdelhamid A, Attreed NJ, Campbell WW, Channell AM, Chassagne P, Culp KR, Fletcher SJ, Fortes MB, Fuller N, Gaspar PM, Gilbert DJ, Heathcote AC, Kafri MW, Kajii F, Lindner G, Mack GW, Mentes JC, Merlani P, Needham RA, Olde Rikkert MG, Perren A, Powers J, Ranson SC, Ritz P, Rowat AM, Sjostrand F, Smith AC, Stookey JJ, Stotts NA, Thomas DR, Vivanti A, Wakefield BJ, Waldreus N, Walsh NP, Ward S, Potter JF, Hunter P. Clinical symptoms, signs and tests for identification of impending and current water-loss dehydration in older people. Cochrane Database Syst Rev. 2015 Apr 30;2015(4):CD009647. doi: 10.1002/14651858.CD009647.pub2.
PubMed 25924806
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Validation of a Screening Tool to Assess Dehydration in Older Population
- ClinicalTrials.gov ID
- NCT03596580
- Acronym / sponsor ID
- GDST-M
- Conditions
- Dehydration Hypertonic, Aged
- Keywords
- Screening tool
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 222 participants (estimated)
- Lead sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoUniversity, hospital or other
- Study start
- 23 Jul 2018 (actual)
- Primary completion
- Jun 2019 (estimated)
- Study completion
- Jun 2019 (estimated)
- First posted
- 24 Jul 2018 (actual)
- 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.
The study aims to verify the sensitivity and specificity of a tool to assess the state of hydration of the older person to identify those at risk of dehydration.
Detailed description
Dehydration is the result of insufficient fluid intake and can be consequent to an alteration of thirst mechanisms or fluid loss from the intestinal and respiratory tracts. The use of diuretics can lead to dehydration too. The risk of dehydration induced by acute or chronical diseases is increased in older people because of the reduced capacity to maintain a proper fluid balance. Lower muscle mass, reduced kidney function, physical and cognitive disabilities, blunted thirst, and polytherapy are recognized as main factors for dehydration risk in older people.For these reasons, coordinated efforts are necessary to develop comprehensive assessment tool to monitor hydration in hospitalised older adults. We need to develop a pathway of screening to detect early stage dehydration in older patients in order to correct it precociously. Presently, no standardized clinical dehydration assessment method exists and there are relatively few papers investigating hydration status. A new tool was created: the Geriatric Dehydration Screening Tool - Modified doesn't require laboratory parameters, and thus its use is feasible outside hospital settings. The aim of this study is to evaluate the diagnostic accuracy of the Geriatric Dehydration Screening Tool - Modified in the assessment of the hydration status of hospitalized older population.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dehydrated participants | – | –125 participants ≥ 65 years of age at the moment of the interviews; hospitalized in General Medicine; osmolarity ≥ 296 mOsm/L |
| Hydrated participants | – | –97 participants ≥ 65 years of age at the moment of the interviews; hospitalized in General Medicine; osmolarity < 296 mOsm/L |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- The study will concern people aged 65 or over, admitted to the medical departments of the Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico. Critical, pediatric and psychiatric areas are excluded.
Key inclusion criteria (2 listed)
- Complete blood tests: Urea, Glucose, Sodium, Potassium reported not more than 24 hours before the observation;
- Absence of known cognitive impairments (Mini-Mental State Examination > 24).
Key exclusion criteria (2 listed)
- Age < 65;
- Mini-Mental State Examination < 24.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diagnostic accuracy
Time frame: baseline
The diagnostic accuracy of Geriatric Dehydration Screening Tool-Modified in detecting dehydrated older people, compared to the standard reference (serum osmolarity)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2019.
- Background: PubMed 19395070Vivanti A, Harvey K, Ash S. Developing a quick and practical screen to improve the identification of poor hydration in geriatric and rehabilitative care. Arch Gerontol Geriatr. 2010 Mar-Apr;50(2):156-64. doi: 10.1016/j.archger.2009.03.003. Epub 2009 Apr 23.
- Background: PubMed 25739005Rodrigues S, Silva J, Severo M, Inacio C, Padrao P, Lopes C, Carvalho J, do Carmo I, Moreira P. Validation analysis of a geriatric dehydration screening tool in community-dwelling and institutionalized elderly people. Int J Environ Res Public Health. 2015 Mar 2;12(3):2700-17. doi: 10.3390/ijerph120302700.
- Background: PubMed 25924806Hooper L, Abdelhamid A, Attreed NJ, Campbell WW, Channell AM, Chassagne P, Culp KR, Fletcher SJ, Fortes MB, Fuller N, Gaspar PM, Gilbert DJ, Heathcote AC, Kafri MW, Kajii F, Lindner G, Mack GW, Mentes JC, Merlani P, Needham RA, Olde Rikkert MG, Perren A, Powers J, Ranson SC, Ritz P, Rowat AM, Sjostrand F, Smith AC, Stookey JJ, Stotts NA, Thomas DR, Vivanti A, Wakefield BJ, Waldreus N, Walsh NP, Ward S, Potter JF, Hunter P. Clinical symptoms, signs and tests for identification of impending and current water-loss dehydration in older people. Cochrane Database Syst Rev. 2015 Apr 30;2015(4):CD009647. doi: 10.1002/14651858.CD009647.pub2.
- Individual participant dataSharing planned: No
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.
Fondazione Ca' Granda Ospedale Maggiore Policlinico
Milan, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dehydration Hypertonic and Aged, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. 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 22 Feb 2019. 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 Italy. 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. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accuracy (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03596580, which also lists 3 linked publications.
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 22 Feb 2019.