Erasmus MC
Rotterdam, South Holland, 3015GD, Netherlands
NCT Number: NCT05717777
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.
This study is active but is not currently recruiting participants.
Notify Me18 year and older
All sexes
Observational
Rotterdam, South Holland, 3015GD, Netherlands
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
In order to be eligible to participate in this study, a subject must meet all of the following criteria:
Exclusion criteria
A potential subject who meets any of the following criteria will be excluded from participation in this study:
There is no intervention, only observational study
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
Time frame: 30 minutes after entering medical facility
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).
Time frame: 2 weeks and 2 months after EHS/EHE
Morbidity of EHS and HE, clinical disease measured by questionnaires
Time frame: 2 months after EHS/EHE
Productivity loss measured by abscens of work questionnaire
Time frame: 6 months after EHS/EHE
Posttraumatic stress symptoms and PTSD after treatment for EHS and EHE by PCL-5 questionnaire.
Erasmus Medical Center
Other
Acronym: THE HEAT
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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