NCT05717777

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
55

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 19, 2023

Completed
20 days until next milestone

First Posted

Study publicly available on registry

February 8, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

March 12, 2023

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2025

Completed
Last Updated

August 7, 2025

Status Verified

August 1, 2025

Enrollment Period

2.6 years

First QC Date

January 19, 2023

Last Update Submit

August 4, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • cooling rate

    cooling rate of treatment with rotating in ice water soaked towels

    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

    30 minutes after entering medical facility

  • Morbidity of EHS/EHE

    2 weeks and 2 months after EHS/EHE

  • productivity loss (abscens of work) related to EHS and EHE

    2 months after EHS/EHE

  • Posttraumatic stress symptoms after EHS and EHE

    6 months after EHS/EHE

Interventions

There is no intervention, only observational study

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Erasmus MC

Rotterdam, South Holland, 3015GD, Netherlands

Location

MeSH Terms

Conditions

Heat Stress DisordersHeat Exhaustion

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Emergency Physician, MD, PhD

Study Record Dates

First Submitted

January 19, 2023

First Posted

February 8, 2023

Study Start

March 12, 2023

Primary Completion

October 31, 2025

Study Completion

October 31, 2025

Last Updated

August 7, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations