Aged Clinical Trial
Official title:
Clinical Validation of a Screening Tool to Assess Dehydration in Older Population
NCT number | NCT03596580 |
Other study ID # | GDST-M |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | July 23, 2018 |
Est. completion date | June 2019 |
Verified date | February 2019 |
Source | Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Recruiting |
Enrollment | 222 |
Est. completion date | June 2019 |
Est. primary completion date | June 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 65 Years and older |
Eligibility |
Inclusion Criteria: - 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). Exclusion Criteria: - Age < 65; - Mini-Mental State Examination < 24. |
Country | Name | City | State |
---|---|---|---|
Italy | Fondazione Ca' Granda Ospedale Maggiore Policlinico | Milan |
Lead Sponsor | Collaborator |
---|---|
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico |
Italy,
Hooper 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, Sjöstrand F, Smith AC, Stookey JJ, Stotts NA, Thomas DR, Vivanti A, Wakefield BJ, Waldréus 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;(4):CD009647. doi: 10.1002/14651858.CD009647.pub2. Review. — View Citation
Rodrigues S, Silva J, Severo M, Inácio C, Padrão 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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Diagnostic accuracy | The diagnostic accuracy of Geriatric Dehydration Screening Tool-Modified in detecting dehydrated older people, compared to the standard reference (serum osmolarity) | baseline |
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