Clinical Trials Logo
  1. Home
  2. Out-of-hospital Cardiac Arrest
  3. NCT05908630
  4. Details
NCT05908630 Clinical Trial

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
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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of 317 patients have been identified by the Danish Drowning Formula and manually validated (Breindahl et al, 2023, unpublished data).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
Accepts healthy volunteers
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).

Study Design

Related Conditions & MeSH terms

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
See also
  Status Clinical Trial Phase
Recruiting NCT05434910 - Blood Pressure and Cerebral Blood Flow After Cardiac Arrest N/A
Active, not recruiting NCT03700125 - Pre-hospital ECMO in Advanced Resuscitation in Patients With Refractory Cardiac Arrest. ( SUB30 ) N/A
Completed NCT02527694 - CPR Quality Between Flexible Stretcher and Standard Stretcher in OHCA N/A
Completed NCT02899507 - Prophylactic Antibiotics in Comatose Survivors of Out-of-hospital Cardiac Arrest Phase 4
Recruiting NCT02184468 - Survival Study After Out-of-hospital Cardiac Arrest N/A
Completed NCT04085692 - Dispatcher-Assisted CPR: Low-Dose, High-Frequency Simulation-Based Training N/A
Recruiting NCT05029167 - REstrictive Versus LIberal Oxygen Strategy and Its Effect on Pulmonary Hypertension After Out-of-hospital Cardiac Arrest (RELIEPH-study) N/A
Completed NCT04080986 - DOuble SEquential External Defibrillation for Refractory VF N/A
Completed NCT04058925 - Tissue Oxygenation During Cardiopulmonary Resuscitation as a Predictor of Return of Spontaneous Circulation
Enrolling by invitation NCT05113706 - Does Bystanders Emotional State Influence Dispatcher-assisted Cardiopulmonary?Resuscitation
Completed NCT04219306 - Machine Learning Assisted Recognition of Out-of-Hospital Cardiac Arrest During Emergency Calls. N/A
Completed NCT03881865 - P25/30 SSEPs and Neurological Prognosis After Cardiac Arrest
Recruiting NCT04993716 - Epidemiological Study on the Management of Out-of-hospital Cardiac Arrest Survivors in Champagne ArDEnnes
Completed NCT05062785 - Dose-Finding Study of Intranasal Insulin in Healthy Participants Insulin in Healthy Participants Phase 1
Recruiting NCT06122337 - Systemic Evaluation of the Etiologies of Young Adults With Non-traumatic Out-of-hospital Cardiac Arrest
Not yet recruiting NCT04584463 - Factors Associated With CPC 1-2 in 110 Patients Admitted in French ICU for a Myocardial Infarction Complicated by an OHCA.
Recruiting NCT03355885 - Early-onset Pneumonia After Out-of-hospital Cardiac Arrest N/A
Recruiting NCT05132387 - Wroclaw Out-Of-Hospital Cardiac Arrest Registry
Not yet recruiting NCT05969028 - First Responder Airway & Compression Rate Trial N/A
Not yet recruiting NCT06046339 - Left Ventricular Ejection Fraction in Cardiac Arrest Survivors Treated With Extracorporeal Cardiopulmonary Resuscitation