CClinicalTrials.gg
CompletedNCT01387529Updated Aug 6, 2019

Reference Values for Non-invasive Hydration Status Markers H10-14

An observational study in Value Orientation, sponsored by U.S. Army Medical Research and Development Command. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-08-06.

Sponsored by U.S. Army Medical Research and Development Command · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
62
Ages
18 Years and older
Sex
All
01

Study summary

The objective of this study is to establish reference values for non-invasive hydration status markers. Although there are no hypotheses associated with this study, the outcome will help advance the development of non-invasive hydration status monitors (described above and in H08-12; A-15208) capable of detecting dehydration from a single, static measure. The outcome that this research effort supports what is recognized by the military community as a high priority medical technology gap (MOM ICD v1.3, 2008).

Read the detailed description

Disorders of fluid and electrolyte balance in the U.S. military result in at least 125 hospitalizations, two lost duty days per event, and 9,300 ambulatory hospital visits per year (60% hyponatremia, 40% dehydration) (Carter et al., 2005; DoD, 2008). Diarrhea is a major infectious disease threat which requires aggressive i.v. fluid replacement in 30% of U.S. troops deployed to Iraq or Afghanistan (Brown et al., 2009). It is also important to recognize that the management and outcome of the 662 severe or penetrating traumatic brain injuries (TBI) reported for the military in 2009 (DoD, 2010) may be hindered by dehydration (Clifton et al., 2002). Fluid and electrolyte imbalances also contribute to heat illness (Carter et al., 2005) and can substantially impair combat fighting effectiveness (Dupont, 2003).

The importance of developing a valid assessment measure of human hydration status for clinical and field use is recognized by the military community as a high priority medical technology gap (MOM ICD v1.3, 2008). In far forward locations (levels I-II), orthostatic testing or gross symptoms are most commonly used to estimate hydration status (Manning et al., 2007). However, level I-II methods share symptoms with numerous other maladies and are insensitive until dehydration is severe or becomes debilitating (Levitt et al., 1992; McGee, 1999). Definitive hydration assessment in rear roles of medical care (levels III-V) requires invasive serial blood and/or urine measurements (Feig, 1977; Mange, 1997). Thus, a field-expedient technology that provides an accurate, non-invasive assessment of hydration status would improve medical triage by allowing better fluid-electrolyte management by medics in theatre (point of care), and by medical personnel in the rear levels of care (treatment and return to duty).

02

Conditions studied

  • Value Orientation

Keywords

  • Reference Values
03

In context

Lead sponsor

U.S. Army Medical Research and Development Command is the lead sponsor of 151 studies on the registry; 8 are open to participants now.

Of its 23 completed or terminated interventional studies of FDA-regulated products, 16 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Approximately 150 volunteers (military and civilians) will complete this experiment. A sample size of 120 volunteers is recommended for characterizing a sample reference population and constructing reference intervals (Fraser, 2001). A sample size of 150 will allow for the potential loss of data due to equipment or handling errors, and 'bad' samples resulting from volunteer non-compliance. A subset of as many as 50 volunteers will undergo repeat testing (3 days; \~3 hours) for the purpose of determining within-subject variance.

Inclusion criteria

  • male or female subject over the age of 18 years
  • subject in good general health
  • written informed consent for participation in the study
  • report any adverse events?
  • if female of child bearing potential, has the subject confirmed that she is not pregnant
  • if the subject wears contact lenses, is he/she willing to remove them

Exclusion criteria

Exclusion Criteria:

  • Presence of a significant medical condition, which in the opinion of the investigator precludes participation in the study
  • Use of ANY medication other than oral contraceptives
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
62 participants (actual)
06

Study locations

1 site
  • US Army Research Institute of Environmental medicine Thermal and Mountain Meidicine Division
    Natick, Massachusetts 01760-5007, United States
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 6, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT01387529
Lead sponsor
U.S. Army Medical Research and Development Command
Responsible party
Sponsor
First posted
Jul 4, 2011
Start date
Jun 2011
Primary completion
Mar 2013
Completion
Sep 2013
Last update
Aug 6, 2019

Study contacts

Samuel Cheuvront, Ph.D.
principal investigator · US Army Insititute of Environmental Medicine Thermal & Mountain Medicine Div.

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.

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