Fluid Volume During Fluid Shifts

Study Overview
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Brief Summary
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This study is designed to answer the question of if several non-invasive methods are comparable to the invasive clinical gold standard of radiolabeled albumin in terms of detecting changes in fluid volume. 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.

Official Title
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Non-invasive Fluid Volume During Fluid Shifts Technique Validation

Conditions
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Development of Non-invasive Protocol

Intervention / Treatment
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* Other: ethanol dilution


Participation Criteria
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Eligibility Criteria
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Non-smokers Have a BMI<30 Have no chronic disease Be free of medications with known cardiovascular effects

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Aim 1<br>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. | Other: ethanol dilution<br>* Ethanol has been validated against deuterium oxide, the invasive gold standard for determining totally body water<br>|
| Active Comparator: Aim 2<br>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. | Other: ethanol dilution<br>* Ethanol has been validated against deuterium oxide, the invasive gold standard for determining totally body water<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Validation against Gold Standard | The non-invasive methods being investigated will be non-inferior in measuring the blood or fluid volumes in healthy participants when compared to the gold standard. | 2 years |