Human Hydration Status Monitoring
Primary Purpose
Dehydration
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dehydration
Sponsored by
About this trial
This is an interventional basic science trial for Dehydration focused on measuring dehydration, hypohydration, diagnostic accuracy, biological variation, hydration assessment, body mass, osmolality, plasma, saliva, urine
Eligibility 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
Sites / Locations
- USARIEM
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Dehydration
Arm Description
Multiple measures of hydration status were made when subjects were normally hydrated (euhydrated) and when dehydrated. The diagnostic usefulness of the measures was determined.
Outcomes
Primary Outcome Measures
Evidence of clinical dehydration
Dehydration was carefully imposed in healthy human subjects. The diagnostic usefulness of multiple classic and novel dehydration assessment measures was made.
Secondary Outcome Measures
Full Information
NCT ID
NCT01124903
First Posted
May 14, 2010
Last Updated
April 20, 2020
Sponsor
United States Army Research Institute of Environmental Medicine
Collaborators
ChromoLogic, LLC, Intelligent Automation, Inc., Gaia Medical Institute
1. Study Identification
Unique Protocol Identification Number
NCT01124903
Brief Title
Human Hydration Status Monitoring
Official Title
Human Hydration Status Monitoring: Phase I
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
February 2011 (Actual)
Study Completion Date
March 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
United States Army Research Institute of Environmental Medicine
Collaborators
ChromoLogic, LLC, Intelligent Automation, Inc., Gaia Medical Institute
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dehydration
Keywords
dehydration, hypohydration, diagnostic accuracy, biological variation, hydration assessment, body mass, osmolality, plasma, saliva, urine
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
single-sample pre-post design
Masking
Single
Allocation
N/A
Enrollment
31 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dehydration
Arm Type
Experimental
Arm Description
Multiple measures of hydration status were made when subjects were normally hydrated (euhydrated) and when dehydrated. The diagnostic usefulness of the measures was determined.
Intervention Type
Procedure
Intervention Name(s)
Dehydration
Other Intervention Name(s)
Hypohydration
Intervention Description
Subjects were dehydrated by 2 - 7% of body mass over 3-5 hours using exercise-heat stress and fluid restriction.
Primary Outcome Measure Information:
Title
Evidence of clinical dehydration
Description
Dehydration was carefully imposed in healthy human subjects. The diagnostic usefulness of multiple classic and novel dehydration assessment measures was made.
Time Frame
24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
39 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Samuel N Cheuvront, PhD
Organizational Affiliation
United States Army Research Institute of Environmental Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
USARIEM
City
Natick
State/Province
Massachusetts
ZIP/Postal Code
01760-5007
Country
United States
12. IPD Sharing Statement
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Human Hydration Status Monitoring
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