Exertional Heat Illness: Biomarkers for Prediction and Return to Duty (NCT01434979) | Clinical Trial Compass
CompletedNot Applicable
Exertional Heat Illness: Biomarkers for Prediction and Return to Duty
United States, Israel148 participantsStarted 2011-07
Plain-language summary
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.
Who can participate
Age range
18 Years – 45 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Heat tolerance
Timeframe: 2-hour heat test
Trial details
NCT IDNCT01434979
SponsorHenry M. Jackson Foundation for the Advancement of Military Medicine