Physiological Responses to Heat Stress During High-risk Events

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUnited States Army Research Institute of Environmental Medicine

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

The sample population included in this investigation will be that of Soldiers undergoing high-risk training events in military training. There are no gender, race, or ethnicity limitations.

Trial design

Design model

Cohort

Time perspective

Cross-sectional

Treatments tested in this trial

  • None-placebo

    Other intervention

    None - observational study

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Core temperature

Body temperature recorded during training

Time frame
Collected only during training, pre-exercisce, post-exercise, and after recovery (from 0-36 hours)
2

Creatinine from blood serum

Serum creatinine measures to evaluate kidney function

Time frame
Measured at least once every 6 hours for up to 36 hours
3

Alanine aminotransferase from blood samples

Measure of liver function (ALT) from blood

Time frame
Measured at least once every 6 hours for up to 36 hours
4

Aspartate aminotransferase (AST)

Liver function measure (AST) from blood

Time frame
Measured at least once every 6 hours for up to 36 hours

Secondary outcomes

1

Urinary KIM-1

Measure of kidney function (KIM-1) from urine

Time frame
Measured at least once every 6 hours for up to 36 hours
2

Urinary creatinine

Kidney function measures (creatinine) from urine

Time frame
Measured at least once every 6 hours for up to 36 hours
3

Blood sodium concentration

Blood sodium concentration

Time frame
Measured at least once every 6 hours for up to 36 hours

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.