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:
Henry M. Jackson Foundation for the Advancement of Military Medicine
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
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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