Value OrientationNCT01387529
Reference Values for Non-invasive Hydration Status Markers H10-14
An observational study of Value Orientation, run by U.S. Army Medical Research and Development Command at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Value Orientation
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2011to Sep 2013
- Phase
- Observational
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
US Army Research Institute of Environmental medicine Thermal and Mountain Meidicine Division
Natick, Massachusetts, 01760-5007
About this study
Official title: Reference Values for Non-invasive Hydration Status Markers
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).
- Conditions
- Value Orientation
- Keywords
- Reference Values
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2011 (estimated)
- Study startJun 2011
- Primary completionMar 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Value OrientationStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- U.S. Army Medical Research and Development Command
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Samuel Cheuvront, Ph.D., Principal investigator, US Army Insititute of Environmental Medicine Thermal & Mountain Medicine Div.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01387529
- Sponsor's protocol ID
- S-11-15
- Status last verified
- Aug 2019
- First submitted
- 30 Jun 2011
- Last updated
- 6 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reference Values for Non-invasive Hydration Status Markers
- ClinicalTrials.gov ID
- NCT01387529
- Acronym / sponsor ID
- S-11-15
- Conditions
- Value Orientation
- Keywords
- Reference Values
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- U.S. Army Medical Research and Development CommandUS federal agency
- Study start
- Jun 2011
- Primary completion
- Mar 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 4 Jul 2011 (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 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).
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 6 Aug 2019.
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 Cheuvront, Ph.D. principal investigator
US Army Insititute of Environmental Medicine Thermal & Mountain Medicine Div.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Value Orientation, run by U.S. Army Medical Research and Development Command 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 6 inclusion and 2 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 6 Aug 2019. 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.
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 6 Aug 2019.