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Clinical trial

Testing of an Electronic Patch During Dehydration in Healthy Volunteers

ID
Name
CTR041 REO
Description
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.
Trial arms
Trial start
2022-05-30
Estimated PCD
2023-11-03
Trial end
2023-11-03
Status
Completed
Treatment
Dehydration
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.
Arms:
Hydration sensor
Other names:
Dehydration from Furosemide
Rehydration
The subject is rehydrated by oral intake of 1.5 liters Resorb Sport (Nestlé). The subject is monitored for 60 minutes following intake.
Arms:
Hydration sensor
Other names:
Rehydration by Resorb Sport
Size
31
Primary endpoint
Change in impedance following mild dehydration
2 hours
Eligibility criteria
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Open-labeled', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 31, 'type': 'ACTUAL'}}
Updated at
2023-12-20

1 organization

1 product

1 indication

Organization
Mode Sensors
Product
Dehydration
Indication
dehydration