Exertional Heat Illness: Biomarkers for Prediction and Return to Duty

NCT01434979 | Completed

• 1 other identifier: G191FY
• Study Type: observational
• Target: 148
• Locations: 2 countries
• Sites: 2

Brief 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.

Conditions

Heat Illness

Outcome Measures

Primary Outcomes (1)

• Heat tolerance

  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.

  2-hour heat test

Secondary Outcomes (3)

• Fitness

  2-hour heat tolerance test

• Behavioral correlates of heat tolerance

  past month

• Perceived heat strain

  2-hour heat tolerance test and 2-hour control test

Other Outcomes (1)

• Blood pressure in response to heat tolerance

  2-hour heat tolerance test and 2-hour control test

Study Arms (2)

Controls

Active Duty,DoD Beneficiary, or civilian men and women between the ages of 18 and 45 years, with a waist circumference ≤ 39.4 inches (100 cm) will be asked to participate.

Exertional Heat Illness / Stroke

Active duty men and women between the ages of 18 and 45 years will be asked to participate. They must have a clinically documented heat stroke within the last year; they will not be tested any sooner than six weeks following the heat stroke. Heat stroke for the purpose of this study is defined as: a syndrome of hyperthermia, physical collapse or debilitation, and encephalopathy as evidenced by delirium, stupor, or coma, occurring during or immediately following exertion or significant heat exposure.

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

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

Study Sites (2)

Uniformed Services University of the Health Sciences

Bethesda, Maryland, 20814, United States

Location

Heller Institute of Medical Research

Tel Litwinsky, Israel

Location

MeSH Terms

Conditions

Heat Stress Disorders

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Patricia Deuster, PhD, MPH

  Uniformed Services University of the Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2011
• First Posted: September 15, 2011
• Study Start: July 1, 2011
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: October 11, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1); IL (1)