Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05717777 |
| Other study ID # |
9805 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
March 12, 2023 |
| Est. completion date |
October 31, 2025 |
Study information
| Verified date |
September 2023 |
| Source |
Erasmus Medical Center |
| Contact |
Amber Hoek, MD, PhD |
| Phone |
0107040704 |
| Email |
a.e.hoek[@]erasmusmc.nl |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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. 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.
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.
