THE HEAT: Treatment of Exertional Heatstroke witH icE wAter Soaked Towels

Sponsor
Erasmus Medical Center (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05717777
Collaborator
(none)
55
7.7

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: There is no intervention, only observational study

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

Study Type:
Observational
Anticipated Enrollment :
55 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Treatment of Exertional Heatstroke witH icE wAter Soaked Towels
Anticipated Study Start Date :
Mar 12, 2023
Anticipated Primary Completion Date :
Oct 31, 2023
Anticipated Study Completion Date :
Oct 31, 2023

Outcome Measures

Primary Outcome Measures

  1. cooling rate [during treatment in medical facility up to 2 hours after entering the facility]

    cooling rate of treatment with rotating in ice water soaked towels

Secondary Outcome Measures

  1. percentage cooled to a temperature <40°C within 30 minutes [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).

  2. Morbidity of EHS/EHE [2 weeks and 2 months after EHS/EHE]

    Morbidity of EHS and HE, clinical disease measured by questionnaires

  3. productivity loss related to EHS and EHE [2 months after EHS/EHE]

    Productivity loss measured by abscens of work questionnaire

  4. Posttraumatic stress symptoms after EHS and EHE [6 months after EHS/EHE]

    Posttraumatic stress symptoms and PTSD after treatment for EHS and EHE by PCL-5 questionnaire.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

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

Exclusion Criteria:

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)

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Erasmus Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Amber Hoek, Principal Investigator, Emergency Physician, MD, PhD, Erasmus Medical Center
ClinicalTrials.gov Identifier:
NCT05717777
Other Study ID Numbers:
  • 9805
First Posted:
Feb 8, 2023
Last Update Posted:
Feb 8, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 8, 2023