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
  Purpose

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.


Condition
Exertional Heat Illness
Exertional Heat Stroke
Heat Intolerance

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective

Further study details as provided by Henry M. Jackson Foundation for the Advancement of Military Medicine:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Other Outcome Measures:
  • 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.


Estimated Enrollment: 150
Study Start Date: July 2011
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Controls
Cases who have suffered from Exertional Heat Illness / Stroke

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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.

Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01434979

Contacts
Contact: Josh B Kazman, MS 301-295-0303 josh.kazman@usuhs.mil
Contact: Pete Lisman, PhD 301-295=1371 Peter.Lisman@usuhs.mil

Locations
United States, Maryland
Uniformed Services University of the Health Sciences Recruiting
Bethesda, Maryland, United States, 20814
Contact: Josh B Kazman, MS    301-295-0303    josh.kazman@usuhs.mil   
Principal Investigator: Patricia Deuster, PhD, MPH         
Israel
Heller Institute of Medical Research Not yet recruiting
Tel-Hashomer, Israel
Contact: Yuval Heled, PhD, FACSM    035303564    Yuval.Heled@sheba.health.gov.il   
Contact: Chen Fleischmann, MS    (+972) - (0)3-5303565/4    Chen.Fleischmann@sheba.health.gov.il   
Principal Investigator: Yuval Heled, PhD, FACSM         
Sponsors and Collaborators
Henry M. Jackson Foundation for the Advancement of Military Medicine
Investigators
Principal Investigator: Patricia Deuster, PhD, MPH Uniformed Services University of the Health Sciences
  More Information

No publications provided

Responsible Party: Henry M. Jackson Foundation for the Advancement of Military Medicine
ClinicalTrials.gov Identifier: NCT01434979     History of Changes
Other Study ID Numbers: G191FY
Study First Received: September 14, 2011
Last Updated: September 4, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Heat Stroke
Heat Stress Disorders
Wounds and Injuries

ClinicalTrials.gov processed this record on October 23, 2014