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
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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.
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.
118 studies on the registry are indexed under Heat Stress Disorders; 42 are open to participants now.
Browse Heat Stress Disorders studies →11 of the 33 studies in Heat Stress Disorders with a site in United States are open now. Recruiting first, the newest first:
Hartford Hospital · Sites in United States
Ages 18–25
The University of Texas Health Science Center at San Antonio · Sites in United States
Ages 18–60
University of Northern Iowa · Sites in United States
Ages 18–45 · Healthy volunteers
Providence College · Sites in United States
Ages 18–45 · Women only · Healthy volunteers
Harvard School of Public Health (HSPH) · Sites in United States
Ages 55–95
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 →
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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33 studies; the count open now beside each. This study's row is marked.
First in 2009; this study’s year is marked. 9 started in 2025.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 30 is above the median of 27 across 14 observational studies indexed under Heat Stress Disorders.
Median enrollment 24 across the 27 interventional studies, 27 across the 6 observational. Of the 19 that completed or were terminated, 2 (11%) have results posted.
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None of the 33 has an industry lead sponsor. The 10 most frequent:
United States Army Research Institute of Environmental Medicine is the lead sponsor of 68 studies on the registry; 7 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.
United States Army Research Institute of Environmental Medicine has 3 studies filed under Heat Stress Disorders — fewer than ten, so there is no comparison to draw.
5 of the studies in Heat Stress Disorders with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT03042988Vanderbilt University Medical CenterOvernight Trials With Heat Stress in Autonomic Failure Patients With Supine Hypertension | 2026-11-30 |
| NCT06798571Penn State UniversityRole of Menopause in Thermoregulation | 2026-12-01 |
| NCT04284397Penn State UniversityIdentification of Critical Thermal Environments for Aged Adults | 2027-02-27 |
| NCT07472426University of Northern IowaEffects of Creatine Supplementation on Cognitive Measures and Markers of Acute Kidney Injury After Exercise in the Heat | 2027-03 |
| NCT06475339State University of New York at BuffaloPredicting Responses to Exhausting, Prolonged, And Repeated Exercise Demands (PREPARED) for Heat | 2027-03 |
Add all 5 to your calendar (.ics) → With an account.
Among the 33 studies in Heat Stress Disorders with a site in United States, from their registry updates:
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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.
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.
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.
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Exclusion Criteria:
None - observational study
Core temperature
Body temperature recorded during training
Time frame: Collected only during training, pre-exercisce, post-exercise, and after recovery (from 0-36 hours)
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
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
Aspartate aminotransferase (AST)
Liver function measure (AST) from blood
Time frame: Measured at least once every 6 hours for up to 36 hours
Heart rate
Heart rate measured during activity
Time frame: Measured during training only from start of training up to completion (~4 hours)
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
Urinary creatinine
Kidney function measures (creatinine) from urine
Time frame: Measured at least once every 6 hours for up to 36 hours
Blood sodium concentration
Blood sodium concentration
Time frame: Measured at least once every 6 hours for up to 36 hours
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — Not permitted to share as Army data
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.
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 ↗
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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United States Army Research Institute of Environmental Medicine