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

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.

Study Overview

• Status: Unknown
• Conditions: Aged; Dehydration Hypertonic

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 Type: Observational
• Enrollment (Anticipated): 222

Contacts and Locations

Study Locations

• Italy
  • Milan, Italy, 20122
    • Recruiting
    • Fondazione Ca' Granda Ospedale Maggiore Policlinico
    • Contact: Ivana Maria Rosi, Dr; Phone Number: +390255035457; Email: ivana.rosi@policlinico.mi.it
    • Contact: Roberto Milos, Dr; Phone Number: +390255032704; Email: roberto.milos@policlinico.mi.it
    • Principal Investigator: Ivana Maria Rosi, Dr
    • Sub-Investigator: Roberto Milos, Dr
    • Sub-Investigator: Loris Bonetti, Dr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnostic accuracy	The diagnostic accuracy of Geriatric Dehydration Screening Tool-Modified in detecting dehydrated older people, compared to the standard reference (serum osmolarity)	baseline

Collaborators and Investigators

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

Publications and helpful links

General 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 23, 2018
• Primary Completion (Anticipated): June 1, 2019
• Study Completion (Anticipated): June 1, 2019

Study Registration Dates

• First Submitted: July 12, 2018
• First Submitted That Met QC Criteria: July 12, 2018
• First Posted (Actual): July 24, 2018

Study Record Updates

• Last Update Posted (Actual): February 22, 2019
• Last Update Submitted That Met QC Criteria: February 21, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: Screening tool
• Additional Relevant MeSH Terms: Pathologic Processes; Metabolic Diseases; Water-Electrolyte Imbalance; Dehydration
• Other Study ID Numbers: GDST-M

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No