NCT03969355

Brief 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. 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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 25, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

May 25, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 31, 2019

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

March 24, 2023

Status Verified

March 1, 2023

Enrollment Period

4.6 years

First QC Date

May 25, 2019

Last Update Submit

March 23, 2023

Conditions

Keywords

PaediatricIntensive careMortality

Outcome Measures

Primary Outcomes (1)

  • Paediatric intesive care unit mortality

    Mortality of paediatric patients in selected period in intensive care

    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

    During Paediatric intesive care unit (PICU) stay Paediatric patients admitted to the intensive care in selected period (2008-2012. versus 2013-2017)

Study Arms (2)

Paediatric patients 2008-2012

Paediatric patients admitted to intensive care in 2008-2012 who died during PICU stay

Other: Mortality

Paediatric patients 2013-2017

Paediatric patients admitted to intensive care in 2013-2017 who died during PICU stay

Other: Mortality

Interventions

Patients who died during PICU stay

Paediatric patients 2008-2012Paediatric patients 2013-2017

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Paediatric patients admitted to the intensive care in selected period (2008-2012. versus 2013-2017).

You may qualify if:

  • Pediatric patients admitted to intensive care in selected time period

You may not qualify if:

  • Insufficient documentation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Brno

Brno, 62500, Czechia

RECRUITING

MeSH Terms

Interventions

Mortality

Intervention Hierarchy (Ancestors)

Vital StatisticsData CollectionEpidemiologic MethodsInvestigative TechniquesDemographyPopulation CharacteristicsEpidemiologic MeasurementsPublic HealthEnvironment and Public Health

Study Officials

  • Petr Štourač, assoc.Prof.MD.Ph.D

    University Hospital Brno

    STUDY CHAIR

Central Study Contacts

Jozef Klučka, MD

CONTACT

Roman Stoudek, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assoc.prof.MD,Ph.D

Study Record Dates

First Submitted

May 25, 2019

First Posted

May 31, 2019

Study Start

May 25, 2019

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

March 24, 2023

Record last verified: 2023-03

Locations