Lack of body water in the normal population

• Register: ISRCTN
• Last refreshed on: 29 January 2024
• Main ID: ISRCTN12215472
• Date of registration: 18/11/2016
• Prospective Registration: No
• Primary sponsor: Södertälje Hospital
• Public title: Lack of body water in the normal population
• Scientific title: Fluid retention in the normal population
• Date of first enrolment: 17/10/2016
• Target sample size: 40
• Recruitment status: Completed
• URL: https://www.isrctn.com/ISRCTN12215472
• Study type: Interventional
• Study design: Non-randomized study (Diagnostic)
• Phase: Not Applicable

Countries of recruitment

Sweden

Contacts

• Name: Robert Hahn

Key inclusion & exclusion criteria

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

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


Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Fluid retention
Signs and Symptoms

Intervention(s)

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.

Primary Outcome(s)

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(s)

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

Secondary ID(s)

Protocol no 1

Nil known

Source(s) of Monetary Support

Mats Kleberg Foundation

Ethics review

Status:
Approval date:
Contact:

Old ethics approval format; Regional Ethics Board of Stockholm, 15/06/2016, ref: 2016/826-31

Results

• Results available: Yes
• Date Completed: 30/03/2017