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Trials / Active Not Recruiting

Active Not RecruitingNCT05717777

Treatment of Exertional Heatstroke witH icE wAter Soaked Towels

Status
Active Not Recruiting
Phase
Study type
Observational
Enrollment
55 (estimated)
Sponsor
Erasmus Medical Center · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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. 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.

Conditions

Interventions

TypeNameDescription
OTHERThere is no intervention, only observational studyThere is no intervention, only observational study

Timeline

Start date
2023-03-12
Primary completion
2025-10-31
Completion
2025-10-31
First posted
2023-02-08
Last updated
2025-08-07

Locations

1 site across 1 country: Netherlands

Source: ClinicalTrials.gov record NCT05717777. Inclusion in this directory is not an endorsement.