NCT04937465

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Nov 2021

Geographic Reach
1 country

6 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 16, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 24, 2021

Completed
4 months until next milestone

Study Start

First participant enrolled

November 1, 2021

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

November 19, 2021

Status Verified

June 1, 2021

Enrollment Period

12 months

First QC Date

June 16, 2021

Last Update Submit

November 11, 2021

Conditions

Dehydrated, Water-Electrolyte Imbalance, Malnutrition

Outcome Measures

Primary Outcomes (1)

  • Hydration state

    Set correct hydration state with a sensitivity of 0.90 and a specificity of 0.80

    During rehabilitation period (3 - 5 weeks)

Study Arms (1)

Elderly

Elderly (\> 70 yrs) eligible for a short term rehabilitation

Other: No intervention done

Interventions

No intervention doneOTHER

No intervention was done. This was an observational study.

Elderly

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Elderly people eligible for short term (3 - 5 weeks) rehabilitation because of either (i) malnutrition and or dehydration, or (ii) overhydration from heart failure treatment.

You may qualify if:

  • Elderly patients eligible for rehabilitation

You may not qualify if:

  • Subjects with end stage cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Lilleborg helsehus

Oslo, 0569, Norway

Location

Ryen helsehus

Oslo, 0580, Norway

Location

Solvang helsehus

Oslo, 0664, Norway

Location

Øya helsehus

Trondheim, 7030, Norway

Location

Nidarvoll helsehus

Trondheim, 7037, Norway

Location

Søbstad helsehus

Trondheim, 7078, Norway

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples: osmolality, hemoglobin, platelets, leukocytes, sodium, glucose potassium, creatinine, Glomerular filtration rate (GFR), albumin, calcium,

MeSH Terms

Conditions

DehydrationWater-Electrolyte ImbalanceMalnutrition

Condition Hierarchy (Ancestors)

Metabolic DiseasesNutritional and Metabolic DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsNutrition Disorders
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 16, 2021

First Posted

June 24, 2021

Study Start

November 1, 2021

Primary Completion

October 31, 2022

Study Completion

December 31, 2022

Last Updated

November 19, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations

NO(6)