Recruiting

Biomarkers of EHS

Sponsor:

United States Army Research Institute of Environmental Medicine

Code:

NCT06907225

Conditions

Thermoregulation

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

None-placebo

Study Details

Brief summary:

Exertional heat stroke (EHS) affects \~500 Military Personnel and over 100 Soldiers every year, and it is believed that these numbers are underreported. EHS is the most severe form of exertional heat illness (EHI) and can result in substantial, long-lasting organ damage, and even death in severe cases. Based on current knowledge and training needs, it is impossible to prevent every EHS - which shifts the focus from exclusively prevention to a combination of prevention, treatment, and enhancing recovery as much as possible. While many risk factors have been identified and there are adequate treatments available, biomarkers associated with heat stroke risk, recovery, and return-to-duty (RTD) remain largely unclear. The purpose of the proposed study is to enhance knowledge surrounding biomarkers of EHS and long-term health consequences that result from EHS. The investigators will recruit research volunteers for a field study in order to collect pre-, post-, and follow-up measures from a high-risk EHS event (i.e. ruck marches, timed runs) this will allow us to have a basis for comparison between Soldiers who collapse with EHS (from previously collected data) and those that complete high-risk events, but do not collapse. This will allow for comparison between the groups to identify EHS-specific biomarkers that could aid in recovery and RTD decisions for Soldiers.

Conditions

Thermoregulation

Study ID

NCT06907225

Start date

May 31, 2025

Status verified date

Apr, 2026

Completion date

Sep, 2026

Anticipated

Primary completion date

Sep 30, 2025

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Individuals (to include cis- and transgender males and females and nonbinary) 18 years of age or greater
  • Current military service (active, Reserve, or National Guard)
  • Currently participating in training

Exclusion Criteria:

  • Females who are pregnant
  • Any individual currently on a physical profile that restricts running or foot marching
  • History of obstructive disease of the gastrointestinal tract including (but not limited to) diverticulosis, diverticulitis and inflammatory bowel disease, peptic ulcer disease, Crohn's disease, ulcerative colitis.
  • Scheduled MRI within 2 weeks after core temp pill ingestion
  • Known allergies to skin adhesive
  • Blood donation in the past 8 weeks

Study Design

Enrollment

150 participants

Anticipated

Interventions and Outcome Measures

Interventions

None-placebo

None - observational study

Primary outcome measure

  • Core temperature [ Time Frame: Collected only during training, pre-exercisce, post-exercise, and after recovery (from 0-36 hours) ]
  • Creatinine from blood serum [ Time Frame: Measured at least once every 6 hours for up to 36 hours ]
  • Alanine aminotransferase from blood samples [ Time Frame: Measured at least once every 6 hours for up to 36 hours ]
  • Aspartate aminotransferase (AST) [ Time Frame: Measured at least once every 6 hours for up to 36 hours ]
  • Heart rate [ Time Frame: Measured during training only from start of training up to completion (~4 hours) ]

Central Contacts and Locations

Central contacts

Locations

Fort Novosel

Recruiting

Fort Novosel, Alabama, United States, 36362

More Information

Sponsor

United States Army Research Institute of Environmental Medicine

Last update posted

May 5, 2026

Last verified

Apr, 2026

Keywords

  • Thermoregulation
  • Heat illness

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by United States Army Research Institute of Environmental Medicine on 2026-05-05.