Condition category
Signs and Symptoms
Date applied
13/10/2016
Date assigned
18/11/2016
Last edited
18/11/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Urinalysis (a test that evaluates a sample of urine) has been used to detect dehydration in sports medicine, but rarely in hospital patients. The kidneys hold onto water when a person is dehydrated, which can be detected by increasing osmolality (concentration of salts), urine-specific weight, darker urine colour, and a higher concentration of creatinine (a waste product from muscle activity). This approach could have a value in hospital care. The aim of this study is to investigate whether spot urine samples vary over the day and whether there is a relationship between dietary intake of water and how much the urine is concentrated.

Who can participate?
Hospital workers found to have concentrated or dilute urine when screened.

What does the study involve?
For the first week of the study, participants are asked to continue with their usual drinking habits and to keep a record of everything they eat and drink. They also provide urine samples daily which are assessed to detect dehydration. For the second week of the study, participants are asked to drink an additional 1.2 L of water every day. Throughout this time, participants record everything they eat and drink and provide urine samples every day. Before the study starts and then after the first and second week, participants undergo a medical examination in order to assess their general health.

What are the possible benefits and risks of participating?
Participants found to have concentrated urine at the start of the study may benefit from learning how much they should drink to have normally concentrated urine. There are no risks involved with participating.

Where is the study run from?
Södertälje Hospital (Sweden)

When is the study starting and how long is it expected to run for?
February 2016 to November 2017

Who is funding the study?
Mats Kleberg Foundation (Sweden)

Who is the main contact?
Professor Robert Hahn
robert.hahn@sll.se

Trial website

Contact information

Type

Public

Primary contact

Prof Robert Hahn

ORCID ID

http://orcid.org/0000-0002-1528-3803

Contact details

Södertälje Hospital
Research Unit
House 18
6th Floor
Lagmansvägen 15
Södertälje
152 86
Sweden
+46 8 55024670
robert.hahn@sll.se

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Protocol no 1

Study information

Scientific title

Fluid retention in the normal population

Acronym

Study hypothesis

1. Fluid retention in the normal population is caused by lack of sufficient water intake
2. Fluid retention can be reversed by increased water intake

Ethics approval

Regional Ethics Board of Stockholm, 15/06/2016, ref: 2016/826-31

Study design

Non-randomised study

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Fluid retention

Intervention

For the first week of the study participants are asked to continue their normal eating and drinking habits and also to record their dietary/fluid intake and provide daily urine samples. These urine samples are assessed for urine colour, osmolarity, specific weight and creatinine.
In the second week of the study, participants are asked to ingest an additional 1.2 L of water per day. During this time participants continue to record dietary/fluid intake and provide daily urine samples for uranalysis.
Before the study starts and at the end of the first week and second week, participants undergo a medical examination with heart auscultation, blood pressure, the passive leg test and bioimpedance analysis of the body fluid volumes.

Intervention type

Supplement

Phase

Drug names

Primary outcome measures

Composition of urine (urine colour, urinalysis of osmolality, specific weight, and creatinine) is assessed using urinalysis conducted on samples collected daily from baseline to the end of the second week.

Secondary outcome measures

1. Food and fluid intake throughout the study is assessed using food/fluid diaries throughout the both weeks of the study
2. Heart auscultation is assessed by a stethoscope at baseline and at 1 and 2 weeks
3. Blood pressure by Nexfin hemodynamic monitor at baseline and at 1 and 2 weeks
4. Passive leg test by Nexfin hemodynamic monitor at baseline and at 1 and 2 weeks
5. Bioimpednace for measurement of body fluid volumes at baseline and at 1 and 2 weeks

Overall trial start date

01/02/2016

Overall trial end date

01/11/2017

Reason abandoned

Eligibility

Participant inclusion criteria

1. Healthy hospital workers
2. Found after screening to have either concentrated urine or diluted urine

Participant type

Health professional

Age group

Adult

Gender

Both

Target number of participants

40

Participant exclusion criteria

1. Medical disease requiring daily medication
2. Any kind of kidney disorder

Recruitment start date

17/10/2016

Recruitment end date

01/09/2017

Locations

Countries of recruitment

Sweden

Trial participating centre

Södertälje Hospital
Research Unit House 18, 6th Floor Lagmansvägen 15
Södertälje
152 86
Sweden

Sponsor information

Organisation

Södertälje Hospital

Sponsor details

152 86 Södertälje
Södertälje
152 86
Sweden

Sponsor type

Hospital/treatment centre

Website

http://sodertaljesjukhus.se

Funders

Funder type

Charity

Funder name

Mats Kleberg Foundation

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

The result is planned to be published in an international scientific journal.

IPD Sharing plan:
The datasets generated during and/or analysed during the current study are/will be available upon request from Professor Robert Hahn (robert.hahn@sll.se)

Intention to publish date

01/11/2018

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes