Explorative Study on a New Device' Ability to Register Hydration Change in Elderly Subjects During Rehabilitation.

Withdrawn

• Conditions: Dehydrated, Water-Electrolyte Imbalance, Malnutrition
• Interventions: Other: No intervention done

• Registration Number: NCT04937465
• Lead Sponsor: Mode Sensors AS

Brief Summary

Test the ability of continuous measurements from a new sensor patch to set the hydration state in subjects who are malnourished/dehydrated or overhydrated or otherwise not optimally hydrated. Specifically, clinical examination, blood pressure, blood tests, and weight change at the admission and at the discharge will be used to establish the true hydration status of the subjects.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-06
• Study First Submitted: 2021-06-16
• Study First Submitted QC: 2021-06-16
• Study First Posted: 2021-06-24
• Study Start: 2021-11-01
• Last Update Submitted: 2021-11-11
• Last Update Posted: 2021-11-19
• Primary Completion: 2022-10-31
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Elderly patients eligible for rehabilitation

Exclusion Criteria

• Subjects with end stage cancer

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Elderly	No intervention done	Elderly (\> 70 yrs) eligible for a short term rehabilitation

Primary Outcome Measures

Name	Time	Method
Hydration state	During rehabilitation period (3 - 5 weeks)	Set correct hydration state with a sensitivity of 0.90 and a specificity of 0.80

Trial Locations

Locations (6)

Ryen helsehus; 🇳🇴 Oslo, Norway

Lilleborg helsehus; 🇳🇴 Oslo, Norway

Solvang helsehus; 🇳🇴 Oslo, Norway

Øya helsehus; 🇳🇴 Trondheim, Norway

Nidarvoll helsehus; 🇳🇴 Trondheim, Norway

Søbstad helsehus; 🇳🇴 Trondheim, Norway