Dehydration
Conditions
Keywords
Dehydration, Rehydration
Brief summary
The purpose of this study is to investigate the ability of a wearable bioimpedance sensor to detect mild dehydration in healthy volunteers following the administration of Furosemide. In addition, the study will investigate changes in bioimpedance related to normal variation in tissue hydration (circadian changes, skin thickness, posture, and moderate activity). The study will also provide information on the durability of the sensor.
Detailed description
The subjects will use the patches for ten days. During the ten-day period, subjects are exposed to an intervention on day 2 or 3 while being monitored by health personnel: * Subjects are given a diuretic (Furosemide) and monitored for two hours without any intake. * The intervention is followed by intake of a rehydration solution (up to 1500 ml), containing glucose and electrolytes (Resorb Sport, Nestle S.A.).
Interventions
DRUGDehydration
The subject is brought to mild dehydration (loss of approximately 1.5% of body weight) through intravenous injection of up to 40 ug Furosemide. The subject shall not ingest any fluid for the next 120 minutes.
DIETARY_SUPPLEMENTRehydration
The subject is rehydrated by oral intake of 1.5 liters Resorb Sport (Nestlé). The subject is monitored for 60 minutes following intake.
Sponsors
Oslo University Hospital
Mode Sensors AS
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
Open-labeled
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* BMI: 18-30 * Age: 18-60 * Willing to refrain from exercise for the duration of the study * Willing to refrain from bathing, swimming and other physical activity causing considerable sweating/movement (e.g. cycling, mountain hiking, climbing)
Exclusion criteria
* Hypersensitivity to diuretics * Diarrhea * Hypotension or orthostatic hypotension * Urinary retention * Pregnancy or breast feeding * Allergy to medical adhesive or gel * Any planned medical examination during the intervention period * Pacemaker * Use of medication with a significant impact on the body's fluid balance, such as diuretic
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in impedance following mild dehydration | 2 hours | Relative change in extracellular resistance measured by the investigational device following administration of Furosemide compared to control days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in impedance following rehydration | 1 hour | Relative change in extracellular resistance measured by the investigational device following ingestion of 1500 ml Resorb (Nestlé) |
Countries
Norway
Outcome results
None listed