Lack of body water in the normal population

ISRCTN	ISRCTN12215472
DOI	https://doi.org/10.1186/ISRCTN12215472
Secondary identifying numbers	Protocol no 1

Submission date: 13/10/2016
Registration date: 18/11/2016
Last edited: 15/01/2024

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Signs and Symptoms

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

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

Contact information

Prof Robert Hahn
Public

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

ORCID ID	0000-0002-1528-3803
Phone	+46 8 55024670
Email	robert.hahn@sll.se

Study information

Study design	Non-randomized study
Primary study design	Interventional
Secondary study design	Non randomised study
Study setting(s)	Hospital
Study type	Diagnostic
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet
Scientific title	Fluid retention in the normal population
Study objectives	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(s)	Regional Ethics Board of Stockholm, 15/06/2016, ref: 2016/826-31
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	01/02/2016
Completion date	30/03/2017

Eligibility

Participant type(s)	Health professional
Age group	Adult
Sex	Both
Target number of participants	40
Total final enrolment	20
Key inclusion criteria	1. Healthy hospital workers 2. Found after screening to have either concentrated urine or diluted urine
Key exclusion criteria	1. Medical disease requiring daily medication 2. Any kind of kidney disorder
Date of first enrolment	17/10/2016
Date of final enrolment	01/09/2017

Locations

Countries of recruitment

Sweden

Study participating centre

Södertälje Hospital

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

Sponsor information

Södertälje Hospital
Hospital/treatment centre

152 86 Södertälje
Södertälje
152 86
Sweden

Website	http://sodertaljesjukhus.se
"ROR"	https://ror.org/0376t7t08

Funders

Funder type

Charity

Mats Kleberg Foundation

No information available

Results and Publications

Intention to publish date	01/11/2018
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
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)

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/03/2021	18/09/2020	Yes	No
Other publications	retrospective analysis	02/01/2023	20/12/2023	Yes	No
Other publications		12/01/2024	15/01/2024	Yes	No

Editorial Notes

15/01/2024: Publication reference added.
20/12/2023: Publication reference added.
18/09/2020: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
12/02/2018: The oevrall trial end date was changed from 01/11/2017 to 30/03/2017.