Accidental Hypothermia in Drowning-related OHCA

NCT ID: NCT05908630

Last Updated: 2024-03-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

119 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-10-01

Study Completion Date

2024-03-01

Brief Summary

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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.

Detailed Description

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The incidence of accidental hypothermia in patients with out-of-hospital cardiac arrest (OHCA) due to drowning is prevalent. Accidental hypothermia is known to decrease oxygen consumption and hypoxic brain damage in patients with OHCA, but may result from prolonged submersion times, which is shown to increase drowning mortality and morbidity. However, many case reports present extraordinary instances of hypothermic patients with drowning-related OHCA surviving with a good neurological outcome despite prolonged submersion times. A larger, retrospective study is warranted to accurately investigate the role of accidental hypothermia in patients with drowning-related OHCA.

This study is a nationwide, retrospective cohort study with 180-days follow-up from 2016-2021 comparing survival and neurological outcome 180 days after drowning incident in normothermic (≥35C) vs hypothermic (\<35C) patients with drowning-related OHCA. A total of 317 patients have been identified by the Danish Drowning Formula and manually validated (Breindahl et al, 2023, unpublished data). Prehospital data from the DCAR will be linked to in-hospital data using the patients' unique civil registration number and presented the "Utstein style". The primary outcome is composite of mortality or poor neurological outcome 180 days after drowning incident (modified Rankin Scale score \> 3). Secondary outcomes include hospital length of stay (continuous), intensive care unit admission (binary) and length of stay (continuous), need for ECLS (binary) and duration (continuous), need for mechanical ventilation (binary) and duration (continuous), survival to hospital discharge, and 30-day survival.

The investigators expect to provide evidence on the role of accidental hypothermia in drowning-related OHCA to support evidence-based guidelines and improve clinical decision-making in the future.

Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Normothermic drowning patients with OHCA.

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

No interventions assigned to this group

Hypothermic drowning patients with OHCA.

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

Hypothermia

Intervention Type OTHER

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

Interventions

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Hypothermia

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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).
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Prehospital Center, Region Zealand

OTHER

Sponsor Role lead

Responsible Party

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Niklas Breindahl

Medical Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Helle Collatz Christensen

Role: STUDY_DIRECTOR

Prehospital Center, Region Zealand

Locations

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Prehospital Center

Næstved, Region Sjælland, Denmark

Site Status

Countries

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Denmark

Other Identifiers

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DROWN_HYPOTHERMIA

Identifier Type: -

Identifier Source: org_study_id

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