Morbidity, MultiplePaedmortNCT03969355
Mortality in Paediatric Intensive Care
An observational study of Morbidity, Multiple, run by Brno University Hospital at 1 site in Czechia.
Trial summary
Mortality of paediatric patients in intensive care can be considered as on of the parameters of quality of care. Together with the advance in research and medicine there should be a trend towards mortality reduction, however actual data in Czech Republic are not well documented. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Morbidity, Multiple
- What is being tested?
- Mortality
- How many people
- 2,000 participants
- Where
- 1 siteCzechia
- Study dates
- 25 May 2019to 31 Dec 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Paediatric patients admitted to the intensive care in selected period (2008-2012. versus 2013-2017).
Who may be able to join
- Pediatric patients admitted to intensive care in selected time period
Who cannot join
- Insufficient documentation
Trial locations and contacts
1 site in 1 country.
Czechia1 site, 1 recruiting
- Recruiting
University Hospital Brno
Brno, 62500
Jozef Klučka, MD, 532234696 ext. 4200, Klucka.jozef@fnbrno.cz
Roman Stoudek, MD, 532234696 ext. 4200, stoudek.roman@fnbrno.cz
About this study
Official title: Mortality in Tertiary Paediatric Critical Care Centre 2008-2012 Versus 2013-2017: Retrospective Cohort Trial
Mortality of paediatric patients in intensive care can be considered as on of the parameters of quality of care. Together with the advance in research and medicine there should be a trend towards mortality reduction, however actual data in Czech Republic are not well documented. The aim of this retrospective cohort trial was to evaluate the mortality of paediatric intensive care patients admitted to Department of paediatric anaesthesiology and intensive care between two periods 2008-2012 and 2013 and 2017
Read the detailed description
Mortality of paediatric patients in intensive care can be considered as on of the parameters of quality of care. Together with the advance in research and medicine there should be a trend towards mortality reduction, however actual data in Czech Republic are not well documented. The aim of this retrospective cohort trial was to evaluate the mortality of paediatric intensive care patients admitted to Department of paediatric anaesthesiology and intensive care between two periods 2008-2012 and 2013 and 2017. The patients records was retrospectively searched and the mortality was adjusted according to the primary admission diagnosis.
- Conditions
- Morbidity, Multiple
- Being tested
- Mortality
- Keywords
- Paediatric, Intensive care, Mortality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MortalityOther
Patients who died during PICU stay
| Study group | Role | What they receive |
|---|---|---|
| Paediatric patients 2008-2012 | Paediatric patients admitted to intensive care in 2008-2012 who died during PICU stay Receives: Other: Mortality | |
| Paediatric patients 2013-2017 | Paediatric patients admitted to intensive care in 2013-2017 who died during PICU stay Receives: Other: Mortality |
What is being measured
The primary outcome is the main question the study is designed to answer.
Paediatric intesive care unit mortality
Mortality of paediatric patients in selected period in intensive care
Measured: During Paediatric intesive care unit (PICU) stay Paediatric patients admitted to the intensive care in selected period (2008-2012. versus 2013-2017)
Secondary outcomes (1)
Paediatric intesive care unit adjusted mortality
Mortality of paediatric patients in selected period in intensive care according to the admission diagnose and severity of disease
Measured: During Paediatric intesive care unit (PICU) stay Paediatric patients admitted to the intensive care in selected period (2008-2012. versus 2013-2017)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2019
- Study start25 May 2019
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Morbidity, MultipleStudies 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
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brno University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Petr Štourač, MD, Brno University Hospital
- Investigators
- Petr Štourač, assoc.Prof.MD.Ph.D, Study chair, Brno University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03969355
- Sponsor's protocol ID
- KDAR FN Brno 2019/4
- Acronym
- Paedmort
- Status last verified
- Mar 2023
- First submitted
- 25 May 2019
- Last updated
- 24 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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
- Mortality in Tertiary Paediatric Critical Care Centre 2008-2012 Versus 2013-2017: Retrospective Cohort Trial
- ClinicalTrials.gov ID
- NCT03969355
- Acronym / sponsor ID
- Paedmort / KDAR FN Brno 2019/4
- Conditions
- Morbidity, Multiple
- Keywords
- Paediatric, Intensive care, Mortality
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Brno University HospitalUniversity, hospital or other
- Study start
- 25 May 2019 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 31 May 2019 (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.
Mortality of paediatric patients in intensive care can be considered as on of the parameters of quality of care. Together with the advance in research and medicine there should be a trend towards mortality reduction, however actual data in Czech Republic are not well documented. The aim of this retrospective cohort trial was to evaluate the mortality of paediatric intensive care patients admitted to Department of paediatric anaesthesiology and intensive care between two periods 2008-2012 and 2013 and 2017
Detailed description
Mortality of paediatric patients in intensive care can be considered as on of the parameters of quality of care. Together with the advance in research and medicine there should be a trend towards mortality reduction, however actual data in Czech Republic are not well documented. The aim of this retrospective cohort trial was to evaluate the mortality of paediatric intensive care patients admitted to Department of paediatric anaesthesiology and intensive care between two periods 2008-2012 and 2013 and 2017. The patients records was retrospectively searched and the mortality was adjusted according to the primary admission diagnosis.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Paediatric patients 2008-2012 | – | Other: MortalityPaediatric patients admitted to intensive care in 2008-2012 who died during PICU stay |
| Paediatric patients 2013-2017 | – | Other: MortalityPaediatric patients admitted to intensive care in 2013-2017 who died during PICU stay |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Paediatric patients admitted to the intensive care in selected period (2008-2012. versus 2013-2017).
Key inclusion criteria (1 listed)
- Pediatric patients admitted to intensive care in selected time period
Key exclusion criteria (1 listed)
- Insufficient documentation
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 |
|---|---|---|
| MortalityPatients who died during PICU stay | Other | Paediatric patients 2008-2012, Paediatric patients 2013-2017 |
Primary outcome
Paediatric intesive care unit mortality
Time frame: During Paediatric intesive care unit (PICU) stay Paediatric patients admitted to the intensive care in selected period (2008-2012. versus 2013-2017)
Mortality of paediatric patients in selected period in intensive care
1 secondary outcome
Paediatric intesive care unit adjusted mortality
Time frame: During Paediatric intesive care unit (PICU) stay Paediatric patients admitted to the intensive care in selected period (2008-2012. versus 2013-2017)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2023.
- Individual participant dataSharing planned: Undecided
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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.
Petr Štourač, assoc.Prof.MD.Ph.D study chair
Brno University Hospital
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 Morbidity, Multiple, run by Brno University Hospital at 1 site in Czechia.
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: status not confirmed, 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 1 site in Czechia. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jozef Klučka, MD (532234696 ext. 4200, Klucka.Jozef@fnbrno.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Paediatric intesive care unit mortality (time frame: During Paediatric intesive care unit (PICU) stay Paediatric patients admitted to the intensive care in selected period (2008-2012. versus 2013-2017)). 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 24 Mar 2023.