Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
14 participants
INTERVENTIONAL
2018-06-27
2022-10-26
Brief Summary
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It is broken into two studies: Aim 1 Study A is designed as a pilot phase to develop the non-techniques, and Aim 2 Study B is comparing these techniques to the gold standard.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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Aim 1
The ethanol dilution is, in essence, a non-invasive dilution method. It is of interest because of how ethanol readily dissolves itself exclusively into the water space of the body\[4\], is non-toxic in reasonable concentrations, is metabolized in a 0th order reaction above concentrations of 0.015 g/dL\[4\], and there are non-invasive methods for determining blood alcohol concentration\[5, 6\]. Thus, by drinking a known amount of ethanol, total body water can be calculated after a few hours of periodic breathalyzer analyses. Ethanol has been validated against deuterium oxide, the invasive gold standard for determining total body water\[4\]. The ethanol dose will be 0.5g/kg body weight.
ethanol dilution
Ethanol has been validated against deuterium oxide, the invasive gold standard for determining totally body water
Aim 2
30mL/kg body weight of saline will be rapidly infused after the baseline measurements completed in Aim 1. Non-invasive methods for fluid volume determination (CO-pulse-oximetry, ethanol breathalyzer, BIS) will be conducted and change from baseline calculated. To determine if non-invasive fluid volume techniques can accurately determine fluid changes in healthy participants.Non-invasive methods for fluid volume determination (CO-pulse-oximetry, ethanol breathalyzer, BIS) will be conducted and change from baseline calculated.
ethanol dilution
Ethanol has been validated against deuterium oxide, the invasive gold standard for determining totally body water
Interventions
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ethanol dilution
Ethanol has been validated against deuterium oxide, the invasive gold standard for determining totally body water
Eligibility Criteria
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Inclusion Criteria
2. Have a BMI\<30
3. Have no chronic disease
4. Be free of medications with known cardiovascular effects
21 Years
ALL
Yes
Sponsors
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Mayo Clinic
OTHER
Responsible Party
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Bruce Johnson
Consultant
Principal Investigators
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Bruce D Johnson
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Mayo Clinic in Arizona
Scottsdale, Arizona, United States
Mayo Clinic in Florida
Jacksonville, Florida, United States
Mayo Clinic in Rochester
Rochester, Minnesota, United States
Countries
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Related Links
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Mayo Clinic Clinical Trials
Other Identifiers
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17-007104
Identifier Type: -
Identifier Source: org_study_id
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