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Human Hydration Status Monitoring

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ClinicalTrials.gov Identifier: NCT01124903
Recruitment Status : Completed
First Posted : May 17, 2010
Last Update Posted : April 22, 2020
Sponsor:
Collaborators:
ChromoLogic, LLC
Intelligent Automation, Inc.
Gaia Medical Institute
Information provided by (Responsible Party):
United States Army Research Institute of Environmental Medicine

Study Description
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Brief Summary:
The sports medicine literature provides a consensus on what threshold values constitute euhydration (normal body water) using a variety of hydration assessment markers (e.g., blood, urine). The investigators add to this literature by providing decision levels for multiple body fluids which can be used as starting points for diagnosing and treating dehydration. At present, plasma osmolality (Posm) provides the best potential measure for static dehydration assessment (spot measure), while dynamic dehydration assessment (serial monitoring) is best accomplished using change values for Posm, urine specific gravity, or body mass (weight). These findings should be considered useful for clinical, military, and sports medicine communities.

Condition or disease Intervention/treatment Phase
Dehydration Procedure: Dehydration Not Applicable

Detailed Description:

Well-recognized markers for static (one time) or dynamic (monitoring over time) dehydration assessment have not been rigorously tested for their usefulness in clinical, military, and sports medicine communities.

This study evaluated the components of biological variation and accuracy of potential markers in plasma, urine, saliva, and body mass, for static and dynamic dehydration assessment. Design: Eighteen healthy volunteers (13M, 5F) were studied while carefully controlling hydration and numerous pre-analytical factors. Biological variation was determined over three consecutive days using published methods. Atypical values based on statistical deviations from a homeostatic set-point were examined. Measured deviations in body fluid were produced using a separate, prospective dehydration experiment and evaluated by ROC analysis to quantify diagnostic accuracy.

All dehydration markers displayed substantial individuality and half displayed marked heterogeneity of intra-individual variation. Decision levels for all dehydration markers were within one standard deviation of the ROC criterion values and most were nearly identical to the prospective group means after dehydrating volunteers by 1.8 - 7.0% of body mass. However, only plasma osmolality (Posm) showed statistical promise for use in static dehydration assessment. A 301 ± 5 mmol/kg diagnostic decision level is proposed. Reference change values (RCV) of 9 mmol/kg (Posm), 0.010 (urine specific gravity, Usg), and 2.5% change in body mass (Bm) were also statistically valid for dynamic dehydration assessment at the 95% probability level.

Posm is the only useful marker for static dehydration assessment. Posm, Usg, and Bm are valid markers in the setting of dynamic dehydration assessment.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: single-sample pre-post design
Masking: Single
Primary Purpose: Basic Science
Official Title: Human Hydration Status Monitoring: Phase I
Study Start Date : January 2009
Actual Primary Completion Date : February 2011
Actual Study Completion Date : March 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dehydration

Arms and Interventions
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Arm Intervention/treatment
Experimental: Dehydration
Multiple measures of hydration status were made when subjects were normally hydrated (euhydrated) and when dehydrated. The diagnostic usefulness of the measures was determined.
 Procedure: Dehydration
Subjects were dehydrated by 2 - 7% of body mass over 3-5 hours using exercise-heat stress and fluid restriction.
Other Name: Hypohydration


Outcome Measures
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Primary Outcome Measures :
  1. Evidence of clinical dehydration [ Time Frame: 24 hours ]
    Dehydration was carefully imposed in healthy human subjects. The diagnostic usefulness of multiple classic and novel dehydration assessment measures was made.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 39 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • You are a member of the U.S. Army between 18-39 years of age
  • You have passed the APFT within the previous 12 months
  • You have completed and passed a recent medical physical exam
  • You are willing to discuss with OMSO and the Principle Investigator (PI) all medications and supplements you are taking and you are willing to stop taking any supplements not approved by OMSO and the PI.

Exclusion Criteria:

  • You have any physical problems that would make exercise difficult
  • You have ever had a heat injury or have a history of having trouble in the heat
  • You have an allergy to sulfa drugs
  • You have been treated for dry eyes
  • You are pregnant, planning on becoming pregnant during the study, or are presently lactating
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01124903


Locations
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United States, Massachusetts
USARIEM
Natick, Massachusetts, United States, 01760-5007
Sponsors and Collaborators
United States Army Research Institute of Environmental Medicine
ChromoLogic, LLC
Intelligent Automation, Inc.
Gaia Medical Institute
Investigators
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Principal Investigator: Samuel N Cheuvront, PhD United States Army Research Institute of Environmental Medicine
More Information
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Responsible Party: United States Army Research Institute of Environmental Medicine
ClinicalTrials.gov Identifier: NCT01124903    
Other Study ID Numbers: H08-12
First Posted: May 17, 2010    Key Record Dates
Last Update Posted: April 22, 2020
Last Verified: April 2020
Keywords provided by United States Army Research Institute of Environmental Medicine:
dehydration
hypohydration
diagnostic accuracy
biological variation
hydration assessment
 body mass
osmolality
plasma
saliva
urine
Additional relevant MeSH terms:
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Dehydration
Water-Electrolyte Imbalance
Metabolic Diseases
Pathologic Processes