Heat Emergency Awareness and Treatment (HEAT)
NCT03513315
Heat, Heat Collapse
Karachi, Pakistan
View Trial DetailsNCT Number: NCT01434979
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.
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Notify Me18 year–45 year
All sexes
Observational
Heller Institute of Medical Research, Tel Litwinsky, Israel
Purpose: Our 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.
Research Design: This is a prospective cross-sectional study.
Methodology/Technical Approach: The proposed study will examine multiple biomarkers in a group of 100 individuals who have not had an episode of EHS and a prospective study of 50 persons who have had an EHS event. Control subjects will have biomarker assessments before and after an exercise challenge under thermoneutral (TTT) and thermally challenged conditions (heat tolerance test/HTT); differences in the responses to the two tests will be attributed to the heat. In EHS subjects, blood will be obtained at time of injury and then followed up at 6 weeks according to non-EHS controls. In addition, EHS cases will be prospectively followed at 3, 6, 12, and 18 months after the 6-week post assessment. If they are heat tolerant at 6-weeks as determined by a HTT, subsequent measures will include only blood samples and questionnaires, whereas if they are heat intolerant (HIT) at 6-weeks, subsequent measures will include additional HTTs, along with blood samples and questionnaires. As our previous data indicate, approximately 20% of non-EHS persons are HIT; we will test 100 non-EHS and 50 EHI persons in this study. Thus, data will be evaluated with regard to thermotolerance. Importantly, all control participants will undergo two test sessions (HTT and TTT); to control for an order effect, we will randomize the tests.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 2-hour heat test
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.
Time frame: 2-hour heat tolerance test
Body fat and aerobic capacity will be measured to quantify their contribution to heat tolerance.
Time frame: past month
Questionnaires will be used to assess behavioral correlates of heat tolerance, including measures of sleep impairment and executive dysfunction.
Time frame: 2-hour heat tolerance test and 2-hour control test
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.
Time frame: 2-hour heat tolerance test and 2-hour control test
Blood pressure will be recorded to see whether it blood pressure response to exercise in the heat correlates with heat tolerance.
Henry M. Jackson Foundation for the Advancement of Military Medicine
Other
Acronym: Heat3
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