- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01387529
Reference Values for Non-invasive Hydration Status Markers H10-14
Reference Values for Non-invasive Hydration Status Markers
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
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).
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
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Massachusetts
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Natick, Massachusetts, Förenta staterna, 01760-5007
- US Army Research Institute of Environmental medicine Thermal and Mountain Meidicine Division
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
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:
- 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
Studieplan
Hur är studien utformad?
Designdetaljer
Samarbetspartners och utredare
Utredare
- Huvudutredare: Samuel Cheuvront, Ph.D., US Army Insititute of Environmental Medicine Thermal & Mountain Medicine Div.
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Andra studie-ID-nummer
- S-11-15
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