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

This study is currently recruiting participants.
Verified November 2012 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: November 8, 2012
Last verified: November 2012
  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 biosignature 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:

Estimated Enrollment: 150
Study Start Date: July 2011
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 fromalcohol, 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
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: November 8, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Heat Stroke
Stroke
Heat Stress Disorders
Wounds and Injuries
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on June 18, 2013