An observational study in Hypothermia, Accidental, Hypothermia Due to Cold Environment and Drowning, sponsored by Prehospital Center, Region Zealand. Completed at 1 site in Denmark. Per ClinicalTrials.gov, last updated 2024-03-15.
Sponsored by Prehospital Center, Region Zealand · Observational
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.
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of 317 patients have been identified by the Danish Drowning Formula and manually validated (Breindahl et al, 2023, unpublished data).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.
966 studies on the registry are indexed under Heart Arrest; 227 are open to participants now.
This study's enrollment of 119 is below the median of 200 across 383 observational studies indexed under Heart Arrest.
Browse Heart Arrest studies →Prehospital Center, Region Zealand is the lead sponsor of 16 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Drowning persons with out-of-hospital cardiac arrest identified in the Danish Cardiac Arrest Registry (DCAR).
Inclusion Criteria - Drowning persons with:
Exclusion Criteria - Drowning persons will be excluded if:
First in-hospital temperature measurement (using any probe) within 6 hours after hospital admission ≥35C.
First in-hospital temperature measurement (using any probe) within 6 hours after hospital admission \<35C.
Other: Hypothermia
Accidental hypothermia is defined as: "an involuntary drop in core body temperature \<35C"
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
Time frame: 180 days after drowning incident.
Hospital length of stay
Continuous
Time frame: Immediately after hospital discharge
Intensive care unit admission
Binary
Time frame: Immediately after hospital discharge
Intensive care unit length of stay
Continuous
Time frame: Immediately after hospital discharge
Need for ECLS
Binary
Time frame: Immediately after hospital discharge
Duration of ECLS
Continuous
Time frame: Immediately after hospital discharge
Need for mechanical ventilation
Binary
Time frame: Immediately after hospital discharge
Duration of mechanical ventilation
Continuous
Time frame: Immediately after hospital discharge
Survival to hospital discharge
Binary
Time frame: Immediately after hospital discharge
30-day survival
Binary
Time frame: 30 days after drowning incident
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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Prehospital Center, Region Zealand