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CompletedNCT06907225Updated Nov 10, 2026

Physiological Responses to Heat Stress During High-risk Events

An observational study in Thermoregulation, sponsored by United States Army Research Institute of Environmental Medicine. Completed at 2 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-10.

Sponsored by United States Army Research Institute of Environmental Medicine · Observational

Updated Nov 10, 2026Now CompletedStudy documents posted+1 moreGo to Updates ↓

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Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
30
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 33 studies in Heat Stress Disorders with a site in United States — 11 open to participants now, 13 under way, none of them phase 3. Heat Stress Disorders · United States.

Started
2025
with 8 others
Observational
6 of 33
1 open now
Registered
24th of 33
by date
Lead sponsor
3 of 33
United States Army Research Institute of Environmental Medicine

Among the 33 studies in Heat Stress Disorders with a site in United States, this one is one of 9 that started in 2025, is one of 6 observational ones, and was the 24th registered.

Heat Stress Disorders

118 studies on the registry are indexed under Heat Stress Disorders; 42 are open to participants now.

Browse Heat Stress Disorders studies →

Open to participants now

11 of the 33 studies in Heat Stress Disorders with a site in United States are open now. Recruiting first, the newest first:

6 more — sign in →

All 11 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 30 Heat Stress Disorders studies recruiting now, 8 (27%) set no upper age limit and 18 (60%) stop at 75 or younger; 6 take children under 18; 22 take healthy volunteers.

This study: 18 Years and older · all sexes · healthy volunteers too.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 33 studies in Heat Stress Disorders with a site in United States, or all of them as a file.
02

Study 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.

Read the detailed description

Exertional heat stroke (EHS) affects \~500 Military Personnel (MSMR, 2022) and over 100 Soldiers (Giersch et al, 2022) every year. EHS is the most severe form of exertional heat illness and can result in substantial, long-lasting organ damage and sometimes death. While some risk factors for EHS are known (Roberts et al, 2021), and the investigators have effective treatments available (Caldwell et al, 2022), EHS cases are not 100% preventable. Furthermore, it is not possible to investigate EHS directly in the laboratory, as safety criteria limit the core temperatures (Tcore) permitted. Therefore, clinicians must rely on prospective clinical investigations after normal training or events (e.g. road races, marathons, etc.).

Collecting data on Soldiers who experience heat stroke helps further our understanding of potential predisposing factors, recovery, and long-term health consequences. Specifically, biomarkers of cardiac, kidney, muscle, and liver damage can inform recovery and return-to-duty (RTD) decisions, but the direct effect of EHS on these systems remains largely unknown. Recent discussions with international colleagues, including the Surgeon General of the Israeli Defense Force, highlight the need for a prospective identification of those at greatest risk for EHS (BG Elon Glassberg, Surgeon General, Israeli Defense Force, personal communication, September 2022).

The proposed study will utilize a similar approach as that employed by a previous study (Kenney et al, 2012), that examined serum creatine kinase (CK) levels in a cohort of healthy basic trainees at Fort Moore. While 200 IU/L is commonly the upper limit of normal values, they found that trainees often had CK values exceeding 1,000 IU/L, which reflects chronic high-intensity physical training, rather than a pathological condition such as exertional rhabdomyolysis (ER). The findings from this paper have influenced the diagnostic criteria for ER, such that a CK level of 50x the upper limit of normal is often required for diagnosis. The effect, if any, of chronic/routine high intensity physical training on other biomarkers, such as creatinine for acute kidney injury and alanine aminotransferase/aspartate aminotransferase (ALT/AST) for liver injury, is unknown. Knowledge of the 'normal' physiological response to exercise-heat stress, as assessed by biomarkers of end-organ function, may potentially guide healthcare providers diagnostic decision-making process and prevent over-diagnosis of conditions. This in turn may result in shorter limited duty time and improved readiness. The proposed investigation will utilize a similar approach, but in a cohort relevant to EHS.

Whereas most EHS cases occur during ruck marches and timed runs (DeGroot et al, MSMR 2022), what is less clear is what represents a "positive" or adaptive physiological response to these high-risk events. One of the goals of the present project will be to identify biomarkers of "successful" exposure to high-risk events. These biomarkers would be present in individuals who successfully complete the events, but don't experience an exertional heat illness (effectively acting as a healthy control to EHS cases). The prospective quantification of differences between EHS cases and healthy controls could provide insights into useful biomarkers (including markers of kidney, liver, and cardiac injury) to differentiate between patients and aid in the identification and treatment of EHS. The results of this study, therefore, will likely contribute to the identification of EHS-specific biomarkers or biomarker levels (i.e. clinical values) to develop better guidance for prevention, treatment and return-to-duty.

If successful, this work can be followed up by investigating treatments for EHS and their response to biomarkers immediately following hyperthermia and during recovery. Identifying the recovery period for these biomarkers in healthy individuals following high risk events will yield greater knowledge in EHS specific biomarkers and recovery. Follow-on work could also investigate EHS severity and the spectrum of exertional heat injuries to evaluate risk and prognostic factors.

03

Conditions studied

  • Thermoregulation

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Keywords

  • Thermoregulation
  • Heat illness
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study 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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
30 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Interventions

  • OtherNone-placebo

    None - observational study

06

What researchers measure

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

  5. Heart rate

    Heart rate measured during activity

    Time frame: Measured during training only from start of training up to completion (~4 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

07

Study locations

2 sites
  • Fort Novosel
    Fort Novosel, Alabama 36362, United States
  • Field Study
    Fort Jackson, South Carolina 29207, United States
08

References and documents

Publications

  • Roberts WO, Armstrong LE, Sawka MN, Yeargin SW, Heled Y, O'Connor FG. ACSM Expert Consensus Statement on Exertional Heat Illness: Recognition, Management, and Return to Activity. Curr Sports Med Rep. 2021 Sep 1;20(9):470-484. doi: 10.1249/JSR.0000000000000878. PubMed 34524191 ↗
  • Williams VF, Oh GT. Update: Heat illness, active component, U.S. Armed Forces, 2021. MSMR. 2022 Apr 1;29(4):8-14. PubMed 35608520 ↗

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No — Not permitted to share as Army data

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from May 2025 to primary completion in Sep 2025, 3 months.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 24, 2025
First posted
Apr 2, 2025
StartActual
May 31, 2025
Primary completionActual
Sep 30, 2025
CompletionActual
Sep 30, 2026
Last update
Nov 10, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Recruiting→Completed
changed Nov 10, 2026
Enrollment
150 (estimated)→30 (actual)
Nov 10, 2026
Documents
Nov 10, 2026
Show all 1 update
  1. Nov 10, 2026
    Recruiting→Completed
    Documents Informed consent form ↗ posted
    Enrollment 150 (estimated)→30 (actual)
    + 4 other changes: verification date, date precision, contact details and site details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT06907225
Lead sponsor
United States Army Research Institute of Environmental Medicine
Responsible party
Gabrielle Giersch (Research Physiologist, United States Army Research Institute of Environmental Medicine) — Principal investigator
First posted
Apr 2, 2025
Start date
May 31, 2025
Primary completion
Sep 30, 2025
Completion
Sep 30, 2026
Last update
Nov 10, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.

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