Exertional Heat Illness: Biomarkers for Prediction and Return to Duty (Heat3)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by Henry M. Jackson Foundation for the Advancement of Military Medicine
Sponsor:
Information provided by (Responsible Party):
Henry M. Jackson Foundation for the Advancement of Military Medicine
ClinicalTrials.gov Identifier:
NCT01434979
First received: September 14, 2011
Last updated: September 4, 2013
Last verified: September 2013

September 14, 2011
September 4, 2013
July 2011
July 2014   (final data collection date for primary outcome measure)
  • Heat tolerance [ Time Frame: 2-hour heat test ] [ Designated as safety issue: No ]
    Heat tolerance is determined by physiologic response to a 2-hour heat tolerance test. During this test, participants with core temperature greater than 38.5 C and/or heart rate greater than 150 bpm are considered heat intolerant.
  • Genetic response to heat tolerance [ Time Frame: 2-hour heat heat tolerance test ] [ Designated as safety issue: No ]
    DNA microarray will be conducted to see whether certain genes can predict response to the heat. Likewise, RNA microarray of RNA expression pre- and post-heat test will be conducted to further determine genetic pathways of heat intolerance.
Not Provided
Complete list of historical versions of study NCT01434979 on ClinicalTrials.gov Archive Site
  • Fitness [ Time Frame: 2-hour heat tolerance test ] [ Designated as safety issue: No ]
    Body fat and aerobic capacity will be measured to quantify their contribution to heat tolerance.
  • Behavioral correlates of heat tolerance [ Time Frame: past month ] [ Designated as safety issue: No ]
    Questionnaires will be used to assess behavioral correlates of heat tolerance, including measures of sleep impairment and executive dysfunction.
  • Perceived heat strain [ Time Frame: 2-hour heat tolerance test and 2-hour control test ] [ Designated as safety issue: No ]
    Measures of perceived heat strain will be recorded to determine how accurately participants perceive that they are working in the heat, and whether this adds diagnostic value to the heat test.
Not Provided
Blood pressure in response to heat tolerance [ Time Frame: 2-hour heat tolerance test and 2-hour control test ] [ Designated as safety issue: No ]
Blood pressure will be recorded to see whether it blood pressure response to exercise in the heat correlates with heat tolerance.
Not Provided
 
Exertional Heat Illness: Biomarkers for Prediction and Return to Duty
Not Provided

The investigators goal is to monitor and quantify the differential physiologic and biomarker responses of controls to standardized exercise under thermoneutral and thermally challenged conditions and responses of exertional heat stroke (EHS) subjects under a thermal-challenged environment to develop unique bio-signature panels to predict those at risk for exertional heat illness (EHI) and guide return to duty following an episode of EHS.

Not Provided
Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

The target population will include both civilian DOD beneficiary and active duty military men and women, of any race or ethnicity, between the ages of 18 and 45 years.

  • Exertional Heat Illness
  • Exertional Heat Stroke
  • Heat Intolerance
Not Provided
  • Controls
  • Cases who have suffered from Exertional Heat Illness / Stroke
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
150
Not Provided
July 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Federal Civilian Employee, Active Duty, or DoD Beneficiary
  • Between the ages of 18 and 45 years
  • Waist circumference ≤ 39.4 inches (100 cm)
  • Willing to walk/run on a treadmill
  • Willing to undergo exposure in a thermal chamber
  • Willing to maintain their current activity patterns, and to abstain from alcohol, caffeine, and tobacco for 24 hours prior to all sessions
  • For cases who have suffered from a exertional heat illness / exertional heat stroke, must have a clinically documented heat stroke within the past year

Exclusion Criteria:

  • History of malignant hyperthermia
  • Pregnant or lactating
  • Have overt heart disease
  • Have systolic blood pressure over 140 mm Hg, or diastolic pressure over 90 mm Hg
  • Have a waist circumference > 39.4 inches (100 cm)
  • Are older than 45 or younger than 18 years of age
  • Are anemic
  • Are taking psychotropic medication for any mental health disorder
  • Are taking other selected medications (glucose lowering, prednisone or beta blockers)
Both
18 Years to 45 Years
Yes
Contact: Josh B Kazman, MS 301-295-0303 josh.kazman@usuhs.mil
Contact: Pete Lisman, PhD 301-295=1371 Peter.Lisman@usuhs.mil
United States,   Israel
 
NCT01434979
G191FY
Not Provided
Henry M. Jackson Foundation for the Advancement of Military Medicine
Henry M. Jackson Foundation for the Advancement of Military Medicine
Not Provided
Principal Investigator: Patricia Deuster, PhD, MPH Uniformed Services University of the Health Sciences
Henry M. Jackson Foundation for the Advancement of Military Medicine
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP