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OpenTrials
Completed

NCT Number: NCT03447574

Fluid Volume During Fluid Shifts

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.

Completed

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Key information

Conditions

Development of Non-invasive Protocol

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Arizona, Scottsdale, Arizona, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ethanol dilution

Other

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

Primary outcomes

  1. Validation against Gold Standard

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

Non-invasive Fluid Volume During Fluid Shifts Technique Validation

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Feb 27, 2018
Registry last updated
Dec 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.