In-hospital Cardiac ArrestNCT05184972
Coverage and Validity of the Swedish Registry of Cardiopulmonary Resuscitation Regarding In-hospital Cardiac Arrest
An observational study of In-hospital Cardiac Arrest, run by Dalarna University at 1 site in Sweden.
Trial summary
The study will have an observational retrospective cross-sectional design. Patient records and hospital administrative systems at 10 hospitals in Sweden will be searched using ICD-codes to find all patients treated for an in-hospital cardiac arrest (IHCA) during the time period of 20180101 to 20191231. Read more about this study
- Who is it for?
- Ages 29 days and older
- Conditions the study is for
- In-hospital Cardiac Arrest
- How many people
- 1,109 participants
- Where
- 1 siteSweden
- Study dates
- 10 Mar 2022to 6 Sep 2023
- 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 29 days and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: An in-hospital cardiac arrest is defined as an arrest that occurs in a hospitalized patient who had a pulse at the time of admission. A hospital is defined as a facility with twenty-four hours a day care including an intensive care unit and an emergency team. Treatment of a cardiac arrest involves initiation of CPR or defibrillation. Data of patients treated for in-hospital cardiac arrest will be collected from 10 hospitals of varying size during 20180101 to 20191231 in Sweden. Data of reported patients treated for in-hospital cardiac arrest during the same time period at each hospital will be extracted from the SRCR .
Who may be able to join
- All patients after the neonatal period that have been treated for an in-hospital cardiac arrest.
Who cannot join
- Patients with an in-hospital cardiac arrest that is not treated (do not attempt resuscitation) or patients in the neonatal period.
Trial locations and contacts
1 site in 1 country.
About this study
The study will have an observational retrospective cross-sectional design. Patient records and hospital administrative systems at 10 hospitals in Sweden will be searched using ICD-codes to find all patients treated for an in-hospital cardiac arrest (IHCA) during the time period of 20180101 to 20191231. All found patients will be cross-checked against reported patients in the Swedish Registry of Cardiopulmonary Resuscitation (SRCR). Any differences in patient characteristics or regarding situation factors between reported and non-reported patients will be evaluated. Non-reported patients will be retrospectively reported to the registry. An incidence of IHCA will be calculated using the number of patients treated for IHCA divided by number of hospital admissions during the specific time period. Selected variables will be evaluated regarding compliance to report and regarding concordance with patient records. All missing data will be described and evaluated. Local reporting procedures at each hospital will be described and evaluated regarding compliance to report and regarding missing data.
- Conditions
- In-hospital Cardiac Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Non-reported patients treated for in-hospital cardiac arrest | Not described | |
| Reported patients treated for in-hospital cardiac arrest | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of reported patients treated for in-hospital cardiac arrest
To evaluate the proportion of patients treated for in-hospital cardiac arrest that are reported to the SRCR
Measured: During hospital stay (retrospective observation january 1 2018 to december 31 2019)
Secondary outcomes (2)
Incidence of in-hospital cardiac arrest
To calculate an incidence of number of patients treated for in-hospital cardiac arrest based on number of hospital admissions during a specific time period.
Measured: During hospital stay (retrospective observation january 1 2018 to december 31 2019)
Patient characteristics
To evaluate possible differences in patient characteristics or situation factors between reported and non-reported patients treated for in-hospital cardiac arrest.
Measured: During hospital stay (retrospective observation january 1 2018 to december 31 2019)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2022
- Study start10 Mar 2022
- Primary completion12 Jun 2023
- Study completion6 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for In-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
- Other
- Time perspective
- Retrospective
- Enrolment
- 1,109 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dalarna University
- Sponsor type
- University, hospital or other
- Collaborators
- Dalarna County Council, Sweden
- Responsible party
- Principal investigator, Jennie Silverplats, Dalarna University
- Investigators
- Anneli Strömsöe, PhD, Principal investigator, Dalarna University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05184972
- Sponsor's protocol ID
- 2021-04102
- Status last verified
- Sep 2023
- First submitted
- 8 Dec 2021
- Last updated
- 7 Sep 2023
- 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 7 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coverage and Validity of the Swedish Registry of Cardiopulmonary Resuscitation Regarding In-hospital Cardiac Arrest
- ClinicalTrials.gov ID
- NCT05184972
- Acronym / sponsor ID
- 2021-04102
- Conditions
- In-hospital Cardiac Arrest
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,109 participants (actual)
- Lead sponsor
- Dalarna UniversityUniversity, hospital or other
- Collaborators
- Dalarna County Council, Sweden
- Study start
- 10 Mar 2022 (actual)
- Primary completion
- 12 Jun 2023 (actual)
- Study completion
- 6 Sep 2023 (actual)
- First posted
- 11 Jan 2022 (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.
The study will have an observational retrospective cross-sectional design. Patient records and hospital administrative systems at 10 hospitals in Sweden will be searched using ICD-codes to find all patients treated for an in-hospital cardiac arrest (IHCA) during the time period of 20180101 to 20191231. All found patients will be cross-checked against reported patients in the Swedish Registry of Cardiopulmonary Resuscitation (SRCR). Any differences in patient characteristics or regarding situation factors between reported and non-reported patients will be evaluated. Non-reported patients will be retrospectively reported to the registry. An incidence of IHCA will be calculated using the number of patients treated for IHCA divided by number of hospital admissions during the specific time period. Selected variables will be evaluated regarding compliance to report and regarding concordance with patient records. All missing data will be described and evaluated. Local reporting procedures at each hospital will be described and evaluated regarding compliance to report and regarding missing data.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-reported patients treated for in-hospital cardiac arrest | – | – |
| Reported patients treated for in-hospital cardiac arrest | – | – |
Who may qualify
- Ages
- 29 days and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- An in-hospital cardiac arrest is defined as an arrest that occurs in a hospitalized patient who had a pulse at the time of admission. A hospital is defined as a facility with twenty-four hours a day care including an intensive care unit and an emergency team. Treatment of a cardiac arrest involves initiation of CPR or defibrillation. Data of patients treated for in-hospital cardiac arrest will be collected from 10 hospitals of varying size during 20180101 to 20191231 in Sweden. Data of reported patients treated for in-hospital cardiac arrest during the same time period at each hospital will be extracted from the SRCR .
Key inclusion criteria (1 listed)
- All patients after the neonatal period that have been treated for an in-hospital cardiac arrest.
Key exclusion criteria (1 listed)
- Patients with an in-hospital cardiac arrest that is not treated (do not attempt resuscitation) or patients in the neonatal period.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Proportion of reported patients treated for in-hospital cardiac arrest
Time frame: During hospital stay (retrospective observation january 1 2018 to december 31 2019)
To evaluate the proportion of patients treated for in-hospital cardiac arrest that are reported to the SRCR
2 secondary outcomes
Incidence of in-hospital cardiac arrest
Time frame: During hospital stay (retrospective observation january 1 2018 to december 31 2019)
Patient characteristics
Time frame: During hospital stay (retrospective observation january 1 2018 to december 31 2019)
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 7 Sep 2023.
- 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.
Anneli Strömsöe, PhD principal investigator
Dalarna University
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 In-hospital Cardiac Arrest, run by Dalarna University at 1 site in Sweden.
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 7 Sep 2023. 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 Sweden. 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?
Proportion of reported patients treated for in-hospital cardiac arrest (time frame: During hospital stay (retrospective observation january 1 2018 to december 31 2019)). 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 7 Sep 2023.