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

NCT03596580 | Unknown

• 1 other identifier: GDST-M
• Study Type: observational
• Target: 222
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dehydration Hypertonic; Aged

Keywords

Screening tool

Outcome Measures

Primary Outcomes (1)

• Diagnostic accuracy

  The diagnostic accuracy of Geriatric Dehydration Screening Tool-Modified in detecting dehydrated older people, compared to the standard reference (serum osmolarity)

  baseline

Study Arms (2)

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

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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).

You may not qualify if:

• Age \< 65;
• Mini-Mental State Examination \< 24.

Sponsors & Collaborators

• Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico: lead

Study Sites (1)

Fondazione Ca' Granda Ospedale Maggiore Policlinico

Milan, 20122, Italy

RECRUITING

Related Publications (3)

• 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.

  PMID: 19395070 BACKGROUND

• Rodrigues 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.

  PMID: 25739005 BACKGROUND

• 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, 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.

  PMID: 25924806 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood urea, glucose, sodium and potassium; skin and mouth hydration.

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2018
• First Posted: July 24, 2018
• Study Start: July 23, 2018
• Primary Completion: June 1, 2019
• Study Completion: June 1, 2019
• Last Updated: February 22, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)