Fluid Volume During Fluid Shifts

Mayo Clinic

Status: Completed

Conditions: Development of Non-invasive Protocol

Treatments: Other: ethanol dilution

Study type: Interventional

Funder types: Other

Identifiers

NCT03447574

17-007104

Details and patient eligibility

About

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.

Enrollment: 14 patients

Sex: All

Ages: 21+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

1. Non-smokers
2. Have a BMI<30
3. Have no chronic disease
4. Be free of medications with known cardiovascular effects

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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14 participants in 2 patient groups

Aim 1

Experimental group

Description:

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.

Treatment:

Other: ethanol dilution

Aim 2

Active Comparator group

Description:

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.

Treatment:

Other: ethanol dilution