Out-Of-Hospital Cardiac ArrestNCT04784117
Out-of-hospital Cardiac Arrest Epidemiology and Outcomes in Kaunas 2016-2021
An observational study of Out-Of-Hospital Cardiac Arrest, run by Lithuanian University of Health Sciences at 2 sites in Lithuania.
Trial summary
Out-of-hospital cardiac arrest rate is common problem, because of high mortality rate. It is not clear incidence rate, epidemiology and outcomes in Lithuania and Kaunas city included. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Out-Of-Hospital Cardiac Arrest
- What is being tested?
- Dispatcher protocol change
- How many people
- 1,500 participants
- Where
- 2 sitesLithuania
- Study dates
- 1 Jan 2016to 31 Dec 2022
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: OHCA patients of all ages more than 18 years-old with resuscitation commenced or continued by EMS personnel
Who may be able to join
- OHCA patients of all ages more than 18 years-old with resuscitation commenced or continued by EMS personnel were included.
Who cannot join
- obviously dead patients, were excluded
Trial locations and contacts
2 sites in 1 country.
Lithuania2 sites
Kaunas city ambulance station
Kaunas
Lithuanian university of health sciences hospital Kaunas clinics
Kaunas
About this study
Out-of-hospital cardiac arrest rate is common problem, because of high mortality rate. It is not clear incidence rate, epidemiology and outcomes in Lithuania and Kaunas city included.
Read the detailed description
This data reported according to UTSTEIN guidelines could be compared with other countries from the region although not much data is available, but it will be a baseline for future references about processes in patient management, demographics, incidence rate and OHCA outcomes.
- Conditions
- Out-Of-Hospital Cardiac Arrest
- Being tested
- Dispatcher protocol change
- Medical subject headings
- Out-of-Hospital Cardiac Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dispatcher protocol changeOther
In the beginning of 2019 dispatcher protocol was changed to shorten the time of death detection
| Study group | Role | What they receive |
|---|---|---|
| Subgroup 2016-2018 | Subgroup before change of dispatcher protocol | |
| Subgroup 2019-2021 | Subgroup after change of dispatcher protocol Receives: Other: Dispatcher protocol change |
What is being measured
The primary outcome is the main question the study is designed to answer.
The detection of death will be shorter
Measured: 31 Dec 2021
Secondary outcomes (1)
The survival rate will increase
Measured: 31 Dec 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2021
- Study start1 Jan 2016
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Out-Of-Hospital Cardiac ArrestStudies 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
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lithuanian University of Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Egle Vaitkaitiene, Dinas Vaitkaitis, Asta Krikscionaitiene, Ilona Kajokaite, Nerijus Mikelionis
- Responsible party
- Principal investigator, Linas Darginavicius, Lithuanian University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04784117
- Sponsor's protocol ID
- LITOHCA
- Status last verified
- Mar 2023
- First submitted
- 2 Mar 2021
- Last updated
- 24 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: for the purposes of data collection and analysis
Publications
Darginavicius L, Kajokaite I, Mikelionis N, Vencloviene J, Dobozinskas P, Vaitkaitiene E, Vaitkaitis D, Krikscionaitiene A. Short- and long-term survival after out-of-hospital cardiac arrest in Kaunas (Lithuania) from 2016 to 2018. BMC Cardiovasc Disord. 2022 Dec 3;22(1):519. doi: 10.1186/s12872-022-02964-4.
PubMed 36460967
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Out-of-hospital Cardiac Arrest Epidemiology and Outcomes in Kaunas 2016-2021
- ClinicalTrials.gov ID
- NCT04784117
- Acronym / sponsor ID
- LITOHCA
- Conditions
- Out-Of-Hospital Cardiac Arrest
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Lithuanian University of Health SciencesUniversity, hospital or other
- Collaborators
- Egle Vaitkaitiene, Dinas Vaitkaitis, Asta Krikscionaitiene, Ilona Kajokaite, Nerijus Mikelionis
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 5 Mar 2021 (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.
Out-of-hospital cardiac arrest rate is common problem, because of high mortality rate. It is not clear incidence rate, epidemiology and outcomes in Lithuania and Kaunas city included.
Detailed description
This data reported according to UTSTEIN guidelines could be compared with other countries from the region although not much data is available, but it will be a baseline for future references about processes in patient management, demographics, incidence rate and OHCA outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Subgroup 2016-2018 | – | –Subgroup before change of dispatcher protocol |
| Subgroup 2019-2021 | – | Other: Dispatcher protocol changeSubgroup after change of dispatcher protocol |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- OHCA patients of all ages more than 18 years-old with resuscitation commenced or continued by EMS personnel
Key inclusion criteria (1 listed)
- OHCA patients of all ages more than 18 years-old with resuscitation commenced or continued by EMS personnel were included.
Key exclusion criteria (1 listed)
- obviously dead patients, were excluded
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 |
|---|---|---|
| Dispatcher protocol changeIn the beginning of 2019 dispatcher protocol was changed to shorten the time of death detection | Other | Subgroup 2019-2021 |
Primary outcome
The detection of death will be shorter
Time frame: 31 Dec 2021
1 secondary outcome
The survival rate will increase
Time frame: 31 Dec 2021
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 24 Mar 2023.
- Derived from this study: PubMed 36460967Darginavicius L, Kajokaite I, Mikelionis N, Vencloviene J, Dobozinskas P, Vaitkaitiene E, Vaitkaitis D, Krikscionaitiene A. Short- and long-term survival after out-of-hospital cardiac arrest in Kaunas (Lithuania) from 2016 to 2018. BMC Cardiovasc Disord. 2022 Dec 3;22(1):519. doi: 10.1186/s12872-022-02964-4.
- Individual participant dataSharing planned: Yes. for the purposes of data collection and analysis
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Out-Of-Hospital Cardiac Arrest, run by Lithuanian University of Health Sciences at 2 sites in Lithuania.
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 1 inclusion and 1 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 24 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Lithuania. 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?
The detection of death will be shorter (time frame: 31 Dec 2021). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04784117, which also lists 1 linked publication.
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 24 Mar 2023.