Validation of a Screening Tool to Assess Dehydration in Hospitalized Older Population

Aged Clinical Trial

Official title:

Clinical Validation of a Screening Tool to Assess Dehydration in Older Population

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03596580
• Other study ID #: GDST-M
• Status: Recruiting
• Start date: July 23, 2018
• Est. completion date: June 2019

Study information

• Verified date: February 2019
• Source: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Aged
• Dehydration
• Dehydration Hypertonic

Locations

Country	Name	City	State
Italy	Fondazione Ca' Granda Ospedale Maggiore Policlinico	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Country where clinical trial is conducted

Italy, 

References & Publications (3)

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

Outcome

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