Heat Stroke ExertionalTHE HEATNCT05717777
Treatment of Exertional Heatstroke witH icE wAter Soaked Towels
An observational study of Heat Stroke Exertional and Heat Illness, run by Erasmus Medical Center at 1 site in Netherlands.
Trial summary
Exertional heat stroke (EHS) is the most serious form of heat-illness that can occur during sports and exercise. If not recognized and treated immediately mortality rate of EHS is high. Early recognition and initiation of cooling are paramount. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heat Stroke Exertional, Heat Illness, Heat Exhaustion
- How many people
- 55 participants
- Where
- 1 siteNetherlands
- Study dates
- 12 Mar 2023to 31 Oct 2025
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult runners who received medical care for EHS of EHE in the medical facility at the running events organized by Golazo Sports® at the City Pier City and Marathon Rotterdam 2023.
Who may be able to join
- In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- ≥18 years
- Receive medical care at in the medical facility the City Pier City and Marathon Rotterdam 2023
- Tympanic temperature >38.0°C
Who cannot join
- A potential subject who meets any of the following criteria will be excluded from participation in this study:
- Language barrier (not proficient in Dutch or English)
Trial locations and contacts
1 site in 1 country.
About this study
Exertional heat stroke (EHS) is the most serious form of heat-illness that can occur during sports and exercise. If not recognized and treated immediately mortality rate of EHS is high. Early recognition and initiation of cooling are paramount. If temperature is reduced to < 40°C within 30 minutes of symptom onset, most patients recover completely. There are several strategies for cooling in EHS, including cooling with rotating in ice water soaked towels which cover the body of a patient.
The aim of this research is to investigate the effectiveness and safety of treatment of EHS with ice water soaked towels to lower body temperature.
Read the detailed description
Rationale: Exertional heat stroke (EHS) is the most serious form of heat-illness that can occur during sports and exercise. If not recognized and treated immediately mortality rate of EHS is high. Early recognition and initiation of cooling are paramount. If temperature is reduced to < 40°C within 30 minutes of symptom onset, most patients recover without sequelae. Exertional heat exhaustion (EHE) is a precursor of EHS, and might develop in EHS if exercise is not terminated. There are several strategies for cooling in EHS, including cooling with rotating in ice water soaked towels which cover the body of a patient.
Objective: The aim of this research is to investigate the effectiveness and safety of treatment of EHS with ice water soaked towels to lower body temperature. Secondary objectives include cooling rate of ice water soaked towels, morbidity of EHS and HE, productivity loss related to EHS and EHE and the development of posttraumatic stress symptoms and PTSD after treatment for EHS and EHE.
Study design: We will conduct a prospective longitudinal observational study. Patients will be monitored and treated according the national guideline in the medical facility. A follow-up survey will be performed after two weeks and two months.
Study population: All participants of 18 years and older who received medical care for EHS or EHE at the City Pier City race on March 12th 2023 and Rotterdam Marathon on April 16th 2023.
Main study parameters/endpoints: Primary outcome will be the cooling rate of treatment with rotating in ice water soaked towels. Secondary outcomes will be percentage of patients with EHS that were cooled to a temperature lower than 40°C within 30 minutes after entering a medical facility (or collapse).
Hypothesis: Cooling with rotating in ice water soaked towels is an effective method for cooling patients with EHS by reducing the body temperature < 40°C within 30 minutes after symptoms.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: There will be no risk from participating in the study and the burden will be low. The questionnaire will take approximately 20-30 minutes at two weeks and two months and 15 minutes at six months.
- Conditions
- Heat Stroke Exertional, Heat Illness, Heat Exhaustion
- Being tested
- There is no intervention, only observational study
- Medical subject headings
- Heat Stress Disorders, Heat Exhaustion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
There is no intervention, only observational studyOther
There is no intervention, only observational study
What is being measured
The primary outcome is the main question the study is designed to answer.
cooling rate
cooling rate of treatment with rotating in ice water soaked towels
Measured: during treatment in medical facility up to 2 hours after entering the facility
Secondary outcomes (4)
percentage cooled to a temperature <40°C within 30 minutes
be percentage of patients with EHS that were cooled to a temperature lower than 40°C within 30 minutes after entering a medical facility (or collapse).
Measured: 30 minutes after entering medical facility
Morbidity of EHS/EHE
Morbidity of EHS and HE, clinical disease measured by questionnaires
Measured: 2 weeks and 2 months after EHS/EHE
productivity loss (abscens of work) related to EHS and EHE
Productivity loss measured by abscens of work questionnaire
Measured: 2 months after EHS/EHE
Posttraumatic stress symptoms after EHS and EHE
Posttraumatic stress symptoms and PTSD after treatment for EHS and EHE by PCL-5 questionnaire.
Measured: 6 months after EHS/EHE
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2023
- Study start12 Mar 2023
- Primary completion31 Oct 2025 (estimated)
- Study completion31 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heat Stroke ExertionalStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amber Hoek, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05717777
- Sponsor's protocol ID
- 9805
- Acronym
- THE HEAT
- Status last verified
- Aug 2025
- First submitted
- 19 Jan 2023
- Last updated
- 7 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Exertional Heatstroke witH icE wAter Soaked Towels
- ClinicalTrials.gov ID
- NCT05717777
- Acronym / sponsor ID
- THE HEAT / 9805
- Conditions
- Heat Stroke Exertional, Heat Illness, Heat Exhaustion
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Study start
- 12 Mar 2023 (actual)
- Primary completion
- 31 Oct 2025 (estimated)
- Study completion
- 31 Oct 2025 (estimated)
- First posted
- 8 Feb 2023 (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.
Exertional heat stroke (EHS) is the most serious form of heat-illness that can occur during sports and exercise. If not recognized and treated immediately mortality rate of EHS is high. Early recognition and initiation of cooling are paramount. If temperature is reduced to < 40°C within 30 minutes of symptom onset, most patients recover completely. There are several strategies for cooling in EHS, including cooling with rotating in ice water soaked towels which cover the body of a patient.
The aim of this research is to investigate the effectiveness and safety of treatment of EHS with ice water soaked towels to lower body temperature.
Detailed description
Rationale: Exertional heat stroke (EHS) is the most serious form of heat-illness that can occur during sports and exercise. If not recognized and treated immediately mortality rate of EHS is high. Early recognition and initiation of cooling are paramount. If temperature is reduced to < 40°C within 30 minutes of symptom onset, most patients recover without sequelae. Exertional heat exhaustion (EHE) is a precursor of EHS, and might develop in EHS if exercise is not terminated. There are several strategies for cooling in EHS, including cooling with rotating in ice water soaked towels which cover the body of a patient.
Objective: The aim of this research is to investigate the effectiveness and safety of treatment of EHS with ice water soaked towels to lower body temperature. Secondary objectives include cooling rate of ice water soaked towels, morbidity of EHS and HE, productivity loss related to EHS and EHE and the development of posttraumatic stress symptoms and PTSD after treatment for EHS and EHE.
Study design: We will conduct a prospective longitudinal observational study. Patients will be monitored and treated according the national guideline in the medical facility. A follow-up survey will be performed after two weeks and two months.
Study population: All participants of 18 years and older who received medical care for EHS or EHE at the City Pier City race on March 12th 2023 and Rotterdam Marathon on April 16th 2023.
Main study parameters/endpoints: Primary outcome will be the cooling rate of treatment with rotating in ice water soaked towels. Secondary outcomes will be percentage of patients with EHS that were cooled to a temperature lower than 40°C within 30 minutes after entering a medical facility (or collapse).
Hypothesis: Cooling with rotating in ice water soaked towels is an effective method for cooling patients with EHS by reducing the body temperature < 40°C within 30 minutes after symptoms.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: There will be no risk from participating in the study and the burden will be low. The questionnaire will take approximately 20-30 minutes at two weeks and two months and 15 minutes at six months.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult runners who received medical care for EHS of EHE in the medical facility at the running events organized by Golazo Sports® at the City Pier City and Marathon Rotterdam 2023.
Key inclusion criteria (4 listed)
- In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- ≥18 years
- Receive medical care at in the medical facility the City Pier City and Marathon Rotterdam 2023
- Tympanic temperature >38.0°C
Key exclusion criteria (2 listed)
- A potential subject who meets any of the following criteria will be excluded from participation in this study:
- Language barrier (not proficient in Dutch or English)
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 |
|---|---|---|
| There is no intervention, only observational studyThere is no intervention, only observational study | Other | – |
Primary outcome
cooling rate
Time frame: during treatment in medical facility up to 2 hours after entering the facility
cooling rate of treatment with rotating in ice water soaked towels
4 secondary outcomes
percentage cooled to a temperature <40°C within 30 minutes
Time frame: 30 minutes after entering medical facility
Morbidity of EHS/EHE
Time frame: 2 weeks and 2 months after EHS/EHE
productivity loss (abscens of work) related to EHS and EHE
Time frame: 2 months after EHS/EHE
Posttraumatic stress symptoms after EHS and EHE
Time frame: 6 months after EHS/EHE
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 7 Aug 2025.
- Individual participant dataSharing planned: No
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heat Stroke Exertional and Heat Illness, run by Erasmus Medical Center at 1 site in Netherlands.
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 2 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: under way, not looking for participants, as of the sponsor's last update on 7 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cooling rate (time frame: during treatment in medical facility up to 2 hours after entering the facility). 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 7 Aug 2025.