Fluid Volume During Fluid Shifts

Not Applicable

Completed

• Conditions: Development of Non-invasive Protocol
• Interventions: Other: ethanol dilution

• Registration Number: NCT03447574
• Lead Sponsor: Mayo Clinic

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-02-16
• Study First Submitted QC: 2018-02-21
• Study First Posted: 2018-02-27
• Study Start: 2018-06-27
• Primary Completion: 2022-10-26
• Study Completion: 2022-10-26
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-07
• Last Update Posted: 2022-12-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Aim 1	ethanol dilution	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.
Aim 2	ethanol dilution	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.

Primary Outcome Measures

Name	Time	Method
Validation against Gold Standard	2 years	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.

Trial Locations

Locations (3)

Mayo Clinic in Arizona; 🇺🇸 Scottsdale, Arizona, United States

Mayo Clinic in Florida; 🇺🇸 Jacksonville, Florida, United States

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States