ClinicalTrials.gg
Not yet recruitingNCT07743619Updated Nov 3, 2026

Rapid Cool: Heat Stroke Treatment

An interventional study of Recirculated water and Phoenix protocol in Hyperthermia, sponsored by State University of New York at Buffalo. Not yet recruiting. Open to participants aged 18 Years to 39 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-03.

Sponsored by State University of New York at Buffalo · Not applicable, Interventional, and Treatment

Updated Nov 3, 2026Start date movedGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years to 39 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Hyperthermia

Keywords

  • heat stroke
  • cooling
  • water
  • exercise
03

In context

Hyperthermia

256 studies on the registry are indexed under Hyperthermia; 73 are open to participants now.

This study's planned enrollment of 20 is below the median of 40 across 232 interventional studies indexed under Hyperthermia.

Browse Hyperthermia studies →

Lead sponsor

State University of New York at Buffalo is the lead sponsor of 294 studies on the registry; 63 are open to participants now.

Of its 19 completed or terminated interventional studies of FDA-regulated products, 15 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 39 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

  1. Adult participant (18 - 39 years old)
  2. (BMI) 18 - 30 kg/m2
  3. At least moderate intensity aerobic exercise ≥60 min per week
  4. Participant is able and willing to follow study procedures

Exclusion criteria

Exclusion Criteria:

  1. History of cardiovascular, neurological, metabolic, pulmonary, renal, gastrointestinal, or disease
  2. Taking prescription medication (with exception of psychiatric medication)
  3. If taking a psychiatric medication, the dosage has changed within the month prior to first study visit
  4. Cannot abstain from taking over-the-counter medications or supplements for 24 hours before study visits (with exception of vitamins)
  5. Resting systolic blood pressure ≥130 mmHg and/or diastolic blood pressure ≥90 mmHg
  6. Resting heart rate of ≥100 beats per minute
  7. Regular smoker of cigarettes or has regularly smoked in the past year
  8. Musculoskeletal injury/condition that negatively impacts the protocol
  9. History of heat illness that resulted in a visit to a medical center in the past 2 years
  10. Has donated blood or plasma in the past 3 months
  11. Has taken antibiotics or within 4 weeks of enrollment
  12. Has a medical implant device such as a pacemaker, patient monitoring system, or metallic implant
  13. Has a full or partially amputated limb
  14. Pregnant or breastfeeding
  15. Study physician or PI discretion based on any other medical condition or medication
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Active comparator
    Phoenix Protocol First

    Traditional cooling with ice and water trial first, followed by Recirculated water trial

    Procedure: Recirculated water · Procedure: Phoenix protocol

  • Experimental
    Recirculated Cooling First

    Recirculated water trial first, followed by Traditional cooling with ice and water trial

    Procedure: Recirculated water · Procedure: Phoenix protocol

Interventions

  • ProcedureRecirculated water

    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

  • ProcedurePhoenix protocol

    Participants will lie in a thick plastic bag filled with ice and water, placed on top of a cot

06

What researchers measure

Primary outcomes

  1. Cooling Rate

    Internal body temperature reduction throughout cooling

    Time frame: 30 minutes post-exercise

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: 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.

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Start date
Sep 21, 2026→Nov 21, 2026
Nov 3, 2026
Show all 1 update
  1. Nov 3, 2026
    Start date Sep 21, 2026→Nov 21, 2026
    + 1 other change: verification date

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
NCT07743619
Responsible party
Riana Pryor (Principal Investigator, State University of New York at Buffalo) — Principal investigator
First posted
Aug 4, 2026
Start date
Nov 21, 2026 (estimated)
Primary completion
Aug 31, 2027 (estimated)
Completion
Aug 31, 2027 (estimated)
Last update
Nov 3, 2026

Study contacts

Riana Pryor, PhD
Contact
rpryor@buffalo.edu
7163489306

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 not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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