HyperthermiaNCT07743619
Rapid Cool: Heat Stroke Treatment
A study testing Recirculated water and Phoenix protocol in people with Hyperthermia, run by State University of New York at Buffalo.
Trial summary
Hot climates such as in Phoenix, AZ commonly have individuals experiencing heat stroke, a life-threatening medical emergency. The dangerously high body temperature can result in death if not treated immediately with rapid body cooling. Read more about this study
- Who is it for?
- Ages 18 to 39 yearsHealthy volunteers can take part
- Conditions the study is for
- Hyperthermia
- What is being tested?
- Recirculated water and Phoenix protocol
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 21 Sep 2026to 31 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 39 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adult participant (18 - 39 years old)
- Body mass index (BMI) 18 - 30 kg/m2
- At least moderate intensity aerobic exercise ≥60 min per week
- Participant is able and willing to follow study procedures
Who cannot join
- History of cardiovascular, neurological, metabolic, pulmonary, renal, gastrointestinal, or autoimmune disease
- Taking prescription medication (with exception of psychiatric medication)
- If taking a psychiatric medication, the dosage has changed within the month prior to first study visit
- Cannot abstain from taking over-the-counter medications or supplements for 24 hours before study visits (with exception of vitamins)
- Resting systolic blood pressure ≥130 mmHg and/or diastolic blood pressure ≥90 mmHg
- Resting heart rate of ≥100 beats per minute
Show all 15Show fewer
- Regular smoker of cigarettes or has regularly smoked in the past year
- Musculoskeletal injury/condition that negatively impacts the protocol
- History of heat illness that resulted in a visit to a medical center in the past 2 years
- Has donated blood or plasma in the past 3 months
- Has taken antibiotics or corticosteroids within 4 weeks of enrollment
- Has a medical implant device such as a pacemaker, patient monitoring system, or metallic implant
- Has a full or partially amputated limb
- Pregnant or breastfeeding
- Study physician or PI discretion based on any other medical condition or medication
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Hot climates such as in Phoenix, AZ commonly have individuals experiencing heat stroke, a life-threatening medical emergency. The dangerously high body temperature can result in death if not treated immediately with rapid body cooling. Rapid core temperature reduction within 30 min of diagnosis results in 100% survival and positive outcomes. While this is easily achieved with whole-body cold water immersion, this modality is not feasible in an ambulance.
The Phoenix emergency medical services protocol consists of lying the patient on a large volume of ice. While this is somewhat effective, this cooling strategy results in a sub-optimal cooling rate, difficulty obtaining this large volume of ice, and a very wet ambulance as the ice melts. Recently, a company created a cooling strategy that utilizes a small amount of ice and a small amount of recirculated water to keep the patient cool. The purpose of this study is to determine the core temperature cooling rate of this cooling strategy and compare it to the cooling rate of the currently used Phoenix protocol.
- Conditions
- Hyperthermia
- Being tested
- Recirculated water, Phoenix protocol
- Keywords
- heat stroke, cooling, water, exercise
- Medical subject headings
- Hyperthermia, Heat Stroke, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recirculated waterProcedure or surgery
Participants will lie in a thick plastic bag with ice and water, placed on top of a cot, with the water circulated using a pump
Phoenix protocolProcedure or surgery
Participants will lie in a thick plastic bag filled with ice and water, placed on top of a cot
| Study group | Role | What they receive |
|---|---|---|
| Phoenix Protocol First | Active comparator | Traditional cooling with ice and water trial first, followed by Recirculated water trial Receives: Procedure: Recirculated water; Procedure: Phoenix protocol |
| Recirculated Cooling First | Experimental | Recirculated water trial first, followed by Traditional cooling with ice and water trial Receives: Procedure: Recirculated water; Procedure: Phoenix protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cooling Rate
Internal body temperature reduction throughout cooling
Measured: 30 minutes post-exercise
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2026
- Study start21 Sep 2026 (estimated)
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperthermiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- State University of New York at Buffalo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Riana Pryor, State University of New York at Buffalo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07743619
- Sponsor's protocol ID
- STUDY00010755
- Status last verified
- Jul 2026
- First submitted
- 30 Jul 2026
- Last updated
- 4 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: A spreadsheet of the cleaned, coded data for all variables will be shared with researchers upon reasonable written request. In addition to the dataset, a study protocol, data dictionary defining the variables, and data collection instruments can be shared.
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rapid Cool: Heat Stroke Treatment
- ClinicalTrials.gov ID
- NCT07743619
- Acronym / sponsor ID
- STUDY00010755
- Conditions
- Hyperthermia
- Keywords
- heat stroke, cooling, water, exercise
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- State University of New York at BuffaloUniversity, hospital or other
- Study start
- 21 Sep 2026 (estimated)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 4 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Hot climates such as in Phoenix, AZ commonly have individuals experiencing heat stroke, a life-threatening medical emergency. The dangerously high body temperature can result in death if not treated immediately with rapid body cooling. Rapid core temperature reduction within 30 min of diagnosis results in 100% survival and positive outcomes. While this is easily achieved with whole-body cold water immersion, this modality is not feasible in an ambulance.
The Phoenix emergency medical services protocol consists of lying the patient on a large volume of ice. While this is somewhat effective, this cooling strategy results in a sub-optimal cooling rate, difficulty obtaining this large volume of ice, and a very wet ambulance as the ice melts. Recently, a company created a cooling strategy that utilizes a small amount of ice and a small amount of recirculated water to keep the patient cool. The purpose of this study is to determine the core temperature cooling rate of this cooling strategy and compare it to the cooling rate of the currently used Phoenix protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phoenix Protocol First | Active comparator | Procedure: Recirculated water, Procedure: Phoenix protocolTraditional cooling with ice and water trial first, followed by Recirculated water trial |
| Recirculated Cooling First | Experimental | Procedure: Recirculated water, Procedure: Phoenix protocolRecirculated water trial first, followed by Traditional cooling with ice and water trial |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Adult participant (18 - 39 years old)
- Body mass index (BMI) 18 - 30 kg/m2
- At least moderate intensity aerobic exercise ≥60 min per week
- Participant is able and willing to follow study procedures
Key exclusion criteria (15 listed)
- History of cardiovascular, neurological, metabolic, pulmonary, renal, gastrointestinal, or autoimmune disease
- Taking prescription medication (with exception of psychiatric medication)
- If taking a psychiatric medication, the dosage has changed within the month prior to first study visit
- Cannot abstain from taking over-the-counter medications or supplements for 24 hours before study visits (with exception of vitamins)
- Resting systolic blood pressure ≥130 mmHg and/or diastolic blood pressure ≥90 mmHg
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Recirculated waterParticipants will lie in a thick plastic bag with ice and water, placed on top of a cot, with the water circulated using a pump | Procedure or surgery | Phoenix Protocol First, Recirculated Cooling First |
| Phoenix protocolParticipants will lie in a thick plastic bag filled with ice and water, placed on top of a cot | Procedure or surgery | Phoenix Protocol First, Recirculated Cooling First |
Primary outcome
Cooling Rate
Time frame: 30 minutes post-exercise
Internal body temperature reduction throughout cooling
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2026.
- Individual participant dataSharing planned: Yes. A spreadsheet of the cleaned, coded data for all variables will be shared with researchers upon reasonable written request. In addition to the dataset, a study protocol, data dictionary defining the variables, and data collection instruments can be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Recirculated water and Phoenix protocol in people with Hyperthermia, run by State University of New York at Buffalo.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Riana Pryor, PhD (7163489306, rpryor@buffalo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cooling Rate (time frame: 30 minutes post-exercise). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2026.