Fluid Volume During Fluid Shifts

Non-invasive Fluid Volume During Fluid Shifts Technique Validation

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03447574

Enrollment

Registered

2018-02-27

Start date

2018-06-27

Completion date

2022-10-26

Last updated

2022-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Development of Non-invasive Protocol

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.

Interventions

OTHERethanol dilution

Ethanol has been validated against deuterium oxide, the invasive gold standard for determining totally body water

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

21 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026