Covid19NCT04480515
Does COVID-19 Pandemic Reduce In-hospital Mortality?
An observational study of Covid19 and In-hospital Cardiac Arrest, run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
COVID-19, which emerged in China in December 2019, has become a pandemic with its spread to many countries of the world. Although it is suggested that hospital admissions are reduced due to some reasons such as trauma, during COVID-19 pandemic, it is controversial whether in-hospital mortality rates changed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19, In-hospital Cardiac Arrest
- What is being tested?
- in-hospital mortality rate
- How many people
- 5,000 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 11 Mar 2020to 30 Jun 2020
- 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: All the records of in-hospital mortality will be evaluated
Who may be able to join
- Deaths, with all required data available, occurred within the study hospitals
- centers Accepted to participate with an informed consent
Who cannot join
- lack of consent
- lack of data
- deaths occurred outside the study hospitals
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kanuni Sultan Suleyman Training and Research Hospital
Istanbul, 34303
About this study
COVID-19, which emerged in China in December 2019, has become a pandemic with its spread to many countries of the world. Although it is suggested that hospital admissions are reduced due to some reasons such as trauma, during COVID-19 pandemic, it is controversial whether in-hospital mortality rates changed. Therefore this multi-centered study aimed to determine how in-hospital mortality effected during the pandemic period according to the specific patient groups.
Read the detailed description
COVID-19, which emerged in China in December 2019, has become a pandemic with its spread to many countries of the world. Although it is suggested that hospital admissions are reduced due to some reasons such as trauma, during COVID-19 pandemic, it is controversial whether in-hospital mortality rates changed. Therefore this multi-centered study aimed to determine how in-hospital mortality effected during the pandemic period according to the specific patient groups. Thus, in case of a pandemic, it will be a guide in which patient groups healthcare providers should be more careful about.
- Conditions
- Covid19, In-hospital Cardiac Arrest
- Being tested
- in-hospital mortality rate
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
in-hospital mortality rateOther
In-hospital mortality rate during pandemic of 2020 will be compared with the in-hospital mortality rate of the last year's same time period
What is being measured
The primary outcome is the main question the study is designed to answer.
In-hospital mortality
During the pandemic (March-July), deaths occurred in hospital will be evaluated.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2020
- Study start11 Mar 2020
- Primary completion15 Jun 2020
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies 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
- Other
- Enrolment
- 5,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ramazan Guven, Kanuni Sultan Suleyman Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04480515
- Sponsor's protocol ID
- KSSEAH--IHM
- Status last verified
- Jul 2020
- First submitted
- 17 Jul 2020
- Last updated
- 21 Jul 2020
- Results posted
- 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 21 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does COVID-19 Pandemic Reduce In-hospital Mortality?
- ClinicalTrials.gov ID
- NCT04480515
- Acronym / sponsor ID
- KSSEAH--IHM
- Conditions
- Covid19, In-hospital Cardiac Arrest
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,000 participants (actual)
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research HospitalUniversity, hospital or other
- Study start
- 11 Mar 2020 (actual)
- Primary completion
- 15 Jun 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 21 Jul 2020 (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.
COVID-19, which emerged in China in December 2019, has become a pandemic with its spread to many countries of the world. Although it is suggested that hospital admissions are reduced due to some reasons such as trauma, during COVID-19 pandemic, it is controversial whether in-hospital mortality rates changed. Therefore this multi-centered study aimed to determine how in-hospital mortality effected during the pandemic period according to the specific patient groups.
Detailed description
COVID-19, which emerged in China in December 2019, has become a pandemic with its spread to many countries of the world. Although it is suggested that hospital admissions are reduced due to some reasons such as trauma, during COVID-19 pandemic, it is controversial whether in-hospital mortality rates changed. Therefore this multi-centered study aimed to determine how in-hospital mortality effected during the pandemic period according to the specific patient groups. Thus, in case of a pandemic, it will be a guide in which patient groups healthcare providers should be more careful about.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All the records of in-hospital mortality will be evaluated
Key inclusion criteria (2 listed)
- Deaths, with all required data available, occurred within the study hospitals
- centers Accepted to participate with an informed consent
Key exclusion criteria (3 listed)
- lack of consent
- lack of data
- deaths occurred outside the study hospitals
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 |
|---|---|---|
| in-hospital mortality rateIn-hospital mortality rate during pandemic of 2020 will be compared with the in-hospital mortality rate of the last year's same time period | Other | – |
Primary outcome
In-hospital mortality
Time frame: 4 months
During the pandemic (March-July), deaths occurred in hospital will be evaluated.
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 21 Jul 2020.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Covid19 and In-hospital Cardiac Arrest, run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).
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 3 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 21 Jul 2020. 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 Turkey (Türkiye). 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?
In-hospital mortality (time frame: 4 months). 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 21 Jul 2020.