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ethanol dilution for Non-invasive Protocol Development
N/A
Waitlist Available
Led By Bruce D Johnson
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Non-smokers
Have a BMI<30
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study Summary
This trial is testing if non-invasive methods are as good as the current gold standard for detecting changes in fluid volume. It is split into two studies, with the first study being a pilot to develop the non-invasive techniques.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Validation against Gold Standard
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Aim 1Experimental Treatment1 Intervention
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.
Group II: Aim 2Active Control1 Intervention
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.
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Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,176 Previous Clinical Trials
3,758,037 Total Patients Enrolled
Bruce D JohnsonPrincipal InvestigatorMayo Clinic
2 Previous Clinical Trials
79 Total Patients Enrolled
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