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Accidental Hypothermia in Drowning-related OHCA

The Role of Accidental Hypothermia in Drowning-related Out-of-hospital Cardiac Arrest: A Danish Six-year Observational Cohort Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05908630
Enrollment
119
Registered
2023-06-18
Start date
2023-10-01
Completion date
2024-03-01
Last updated
2024-03-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Detailed description

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of 317 patients have been identified by the Danish Drowning Formula and manually validated (Breindahl et al, 2023, unpublished data).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.

Interventions

OTHERHypothermia

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

Sponsors

Prehospital Center, Region Zealand
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL

Inclusion criteria

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

Exclusion criteria

- Drowning persons will be excluded 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).

Design outcomes

Primary

MeasureTime frameDescription
Survival or poor neurological outcome180 days after drowning incident.The primary outcome is a composite of mortality or poor neurological outcome 180 days after drowning incident according to the Utstein style

Secondary

MeasureTime frameDescription
Intensive care unit admissionImmediately after hospital dischargeBinary
Intensive care unit length of stayImmediately after hospital dischargeContinuous
Need for ECLSImmediately after hospital dischargeBinary
Duration of ECLSImmediately after hospital dischargeContinuous
Hospital length of stayImmediately after hospital dischargeContinuous
Duration of mechanical ventilationImmediately after hospital dischargeContinuous
Survival to hospital dischargeImmediately after hospital dischargeBinary
30-day survival30 days after drowning incidentBinary
Need for mechanical ventilationImmediately after hospital dischargeBinary

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026