Hypothermia, AccidentalNCT05908630
Accidental Hypothermia in Drowning-related OHCA
An observational study of Hypothermia, Accidental and Hypothermia Due to Cold Environment, run by Prehospital Center, Region Zealand at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hypothermia, Accidental, Hypothermia Due to Cold Environment, Drowning
- What is being tested?
- Hypothermia
- How many people
- 119 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Oct 2023to 1 Mar 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
Study population: Drowning persons with out-of-hospital cardiac arrest identified in the Danish Cardiac Arrest Registry (DCAR).
Who may be able to join
- OHCA registered in the DCAR from 2016-2021.
- An in-hospital temperature measurement (using any probe) within 6 hours after hospital admission.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Role of Accidental Hypothermia in Drowning-related Out-of-hospital Cardiac Arrest: A Danish Six-year Observational Cohort Study
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.
Read the 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.
- Conditions
- Hypothermia, Accidental, Hypothermia Due to Cold Environment, Drowning, Out-Of-Hospital Cardiac Arrest
- Being tested
- Hypothermia
- Medical subject headings
- Hypothermia, Drowning, Out-of-Hospital Cardiac Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HypothermiaOther
Accidental hypothermia is defined as: "an involuntary drop in core body temperature <35C"
| Study group | Role | What they receive |
|---|---|---|
| Normothermic drowning patients with OHCA. | First in-hospital temperature measurement (using any probe) within 6 hours after hospital admission ≥35C. | |
| Hypothermic drowning patients with OHCA. | First in-hospital temperature measurement (using any probe) within 6 hours after hospital admission <35C. Receives: Other: Hypothermia |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 180 days after drowning incident.
Secondary outcomes (9)
Hospital length of stay
Continuous
Measured: Immediately after hospital discharge
Intensive care unit admission
Binary
Measured: Immediately after hospital discharge
Intensive care unit length of stay
Continuous
Measured: Immediately after hospital discharge
Need for ECLS
Binary
Measured: Immediately after hospital discharge
Duration of ECLS
Continuous
Measured: Immediately after hospital discharge
Need for mechanical ventilation
Binary
Measured: Immediately after hospital discharge
Duration of mechanical ventilation
Continuous
Measured: Immediately after hospital discharge
Survival to hospital discharge
Binary
Measured: Immediately after hospital discharge
30-day survival
Binary
Measured: 30 days after drowning incident
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2023
- Study start1 Oct 2023
- Primary completion1 Mar 2024
- Study completion1 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypothermia, AccidentalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prehospital Center, Region Zealand
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Niklas Breindahl, Prehospital Center, Region Zealand
- Investigators
- Helle Collatz Christensen, Study director, Prehospital Center, Region Zealand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05908630
- Sponsor's protocol ID
- DROWN_HYPOTHERMIA
- Status last verified
- Mar 2024
- First submitted
- 2 Jun 2023
- Last updated
- 15 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Accidental Hypothermia in Drowning-related Out-of-hospital Cardiac Arrest: A Danish Six-year Observational Cohort Study
- ClinicalTrials.gov ID
- NCT05908630
- Acronym / sponsor ID
- DROWN_HYPOTHERMIA
- Conditions
- Hypothermia, Accidental, Hypothermia Due to Cold Environment, Drowning, Out-Of-Hospital Cardiac Arrest
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- Prehospital Center, Region ZealandUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 1 Mar 2024 (actual)
- First posted
- 18 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normothermic drowning patients with OHCA. | – | –First in-hospital temperature measurement (using any probe) within 6 hours after hospital admission ≥35C. |
| Hypothermic drowning patients with OHCA. | – | Other: HypothermiaFirst in-hospital temperature measurement (using any probe) within 6 hours after hospital admission <35C. |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Drowning persons with out-of-hospital cardiac arrest identified in the Danish Cardiac Arrest Registry (DCAR).
Key inclusion criteria (2 listed)
- OHCA registered in the DCAR from 2016-2021.
- An in-hospital temperature measurement (using any probe) within 6 hours after hospital admission.
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HypothermiaAccidental hypothermia is defined as: "an involuntary drop in core body temperature <35C" | Other | Hypothermic drowning patients with OHCA. |
Primary outcome
Survival or poor neurological outcome
Time frame: 180 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
9 secondary outcomes
Hospital length of stay
Time frame: Immediately after hospital discharge
Intensive care unit admission
Time frame: Immediately after hospital discharge
Intensive care unit length of stay
Time frame: Immediately after hospital discharge
Need for ECLS
Time frame: Immediately after hospital discharge
Duration of ECLS
Time frame: Immediately after hospital discharge
Need for mechanical ventilation
Time frame: Immediately after hospital discharge
Duration of mechanical ventilation
Time frame: Immediately after hospital discharge
Survival to hospital discharge
Time frame: Immediately after hospital discharge
30-day survival
Time frame: 30 days after drowning incident
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Helle Collatz Christensen study director
Prehospital Center, Region Zealand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypothermia, Accidental and Hypothermia Due to Cold Environment, run by Prehospital Center, Region Zealand at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival or poor neurological outcome (time frame: 180 days after drowning incident.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2024.