Accidental Hypothermia in Drowning-related OHCA

Out-Of-Hospital Cardiac Arrest Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05908630
• Other study ID #: DROWN_HYPOTHERMIA
• Status: Completed
• Start date: October 1, 2023
• Est. completion date: March 1, 2024

Study information

• Verified date: March 2024
• Source: Prehospital Center, Region Zealand
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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of 317 patients have been identified by the Danish Drowning Formula and manually validated (Breindahl et al, 2023, unpublished data).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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 119
• Est. completion date: March 1, 2024
• Est. primary completion date: March 1, 2024
• Gender: All
• Age group: N/A and older

Eligibility

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).

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
Denmark	Prehospital Center	Næstved	Region Zealand

Sponsors (1)

Lead Sponsor	Collaborator
Prehospital Center, Region Zealand

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Hospital length of stay	Continuous	Immediately after hospital discharge
Secondary	Intensive care unit admission	Binary	Immediately after hospital discharge
Secondary	Intensive care unit length of stay	Continuous	Immediately after hospital discharge
Secondary	Need for ECLS	Binary	Immediately after hospital discharge
Secondary	Duration of ECLS	Continuous	Immediately after hospital discharge
Secondary	Need for mechanical ventilation	Binary	Immediately after hospital discharge
Secondary	Duration of mechanical ventilation	Continuous	Immediately after hospital discharge
Secondary	Survival to hospital discharge	Binary	Immediately after hospital discharge
Secondary	30-day survival	Binary	30 days after drowning incident