DehydrationNCT01124903
Human Hydration Status Monitoring
A study testing Dehydration in people with Dehydration, run by United States Army Research Institute of Environmental Medicine at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 39 yearsHealthy volunteers can take part
- Conditions the study is for
- Dehydration
- What is being tested?
- Dehydration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2009to Mar 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 39 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Human Hydration Status Monitoring: Phase I
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.
Read the 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.
- Conditions
- Dehydration
- Being tested
- Dehydration
- Keywords
- dehydration, hypohydration, diagnostic accuracy, biological variation, hydration assessment, body mass, osmolality, plasma, saliva, urine
- Medical subject headings
- Dehydration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DehydrationProcedure or surgery
Also called Hypohydration
Subjects were dehydrated by 2 - 7% of body mass over 3-5 hours using exercise-heat stress and fluid restriction.
| Study group | Role | What they receive |
|---|---|---|
| Dehydration | Experimental | Multiple measures of hydration status were made when subjects were normally hydrated (euhydrated) and when dehydrated. The diagnostic usefulness of the measures was determined. Receives: Procedure: Dehydration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2010 (estimated)
- Study startJan 2009
- Primary completionFeb 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DehydrationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- single-sample pre-post design
- Masking
- Single blind
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- United States Army Research Institute of Environmental Medicine
- Sponsor type
- US federal agency
- Collaborators
- ChromoLogic, LLC, Intelligent Automation, Inc., Gaia Medical Institute
- Responsible party
- Sponsor
- Investigators
- Samuel N Cheuvront, PhD, Principal investigator, United States Army Research Institute of Environmental Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01124903
- Sponsor's protocol ID
- H08-12
- Status last verified
- Apr 2020
- First submitted
- 14 May 2010
- Last updated
- 22 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Human Hydration Status Monitoring: Phase I
- ClinicalTrials.gov ID
- NCT01124903
- Acronym / sponsor ID
- H08-12
- Conditions
- Dehydration
- Keywords
- dehydration, hypohydration, diagnostic accuracy, biological variation, hydration assessment, body mass, osmolality, plasma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- United States Army Research Institute of Environmental MedicineUS federal agency
- Collaborators
- ChromoLogic, LLC, Intelligent Automation, Inc., Gaia Medical Institute
- Study start
- Jan 2009
- Primary completion
- Feb 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 17 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Number of arms
- 1
- Model description
- single-sample pre-post design
| Arm | Type | Receives |
|---|---|---|
| Dehydration | Experimental | Procedure: DehydrationMultiple measures of hydration status were made when subjects were normally hydrated (euhydrated) and when dehydrated. The diagnostic usefulness of the measures was determined. |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DehydrationAlso: HypohydrationSubjects were dehydrated by 2 - 7% of body mass over 3-5 hours using exercise-heat stress and fluid restriction. | Procedure or surgery | Dehydration |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samuel N Cheuvront, PhD principal investigator
United States Army Research Institute of Environmental Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dehydration in people with Dehydration, run by United States Army Research Institute of Environmental Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evidence of clinical dehydration (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2020.