Accidental Hypothermia in Drowning-related OHCA

NCT05908630 | Completed

• 1 other identifier: DROWN_HYPOTHERMIA
• Study Type: observational
• Target: 119
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to report mortality and neurological outcome 180 days after drowning incident in patients with accidental hypothermia vs normothermia following drowning-related OHCA in Denmark during a six-year period from 2016-2021.

Conditions

Hypothermia, Accidental; Hypothermia Due to Cold Environment; Drowning; Out-Of-Hospital Cardiac Arrest

Outcome Measures

Primary Outcomes (1)

• Survival or poor neurological outcome

  The primary outcome is a composite of mortality or poor neurological outcome 180 days after drowning incident according to the Utstein style

  180 days after drowning incident.

Secondary Outcomes (9)

• Hospital length of stay

  Immediately after hospital discharge

• Intensive care unit admission

  Immediately after hospital discharge

• Intensive care unit length of stay

  Immediately after hospital discharge

• Need for ECLS

  Immediately after hospital discharge

• Duration of ECLS

  Immediately after hospital discharge

Study Arms (2)

Normothermic drowning patients with OHCA.

First in-hospital temperature measurement (using any probe) within 6 hours after hospital admission ≥35C.

Hypothermic drowning patients with OHCA.

First in-hospital temperature measurement (using any probe) within 6 hours after hospital admission \<35C.

Other: Hypothermia

Interventions

Hypothermia OTHER

Accidental hypothermia is defined as: "an involuntary drop in core body temperature \<35C"

Hypothermic drowning patients with OHCA.

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Drowning persons with out-of-hospital cardiac arrest identified in the Danish Cardiac Arrest Registry (DCAR).

You may qualify if:

• OHCA registered in the DCAR from 2016-2021.
• An in-hospital temperature measurement (using any probe) within 6 hours after hospital admission.

You may not qualify if:

• They have obvious signs of irreversible death (decapitation, decomposition, post-mortem lividity, post-mortem rigidity).
• They are declared dead on scene.
• They have a valid Do-Not-Attempt-Resuscitation order or other code status orders limiting life-sustaining therapies.
• They do not have a valid civil registration number.
• They do not have a valid in-hospital temperature measurement (any probe within 6 hours after hospital admission).

Sponsors & Collaborators

• Prehospital Center, Region Zealand: lead

Study Sites (1)

Prehospital Center

Næstved, Region Sjælland, 4700, Denmark

Location

MeSH Terms

Conditions

Hypothermia; Drowning; Out-of-Hospital Cardiac Arrest

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Death; Pathologic Processes; Wounds and Injuries; Heart Arrest; Heart Diseases; Cardiovascular Diseases

Study Officials

• Helle Collatz Christensen

  Prehospital Center, Region Zealand

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: June 2, 2023
• First Posted: June 18, 2023
• Study Start: October 1, 2023
• Primary Completion: March 1, 2024
• Study Completion: March 1, 2024
• Last Updated: March 15, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)