- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02961153
Mortality in Pediatric Intensive Care Unit
April 9, 2018 updated by: Guoping Lu, Children's Hospital of Fudan University
Epidemiology of Death in the PICU of Southeast China
With the development of national economy and medical technology, patients can extend life rely on high-end medical facilities.
At the same time, the continued treatment cannot bring benefits to children, even resulting in poor quality of life of children and bringing high medical costs.
This makes the limited medical resources are unreasonable distributed.
Research showed that PICU mortality rate halved over ten years ago, but the data did not include death cases who left hospital before death.
However, the death number of out-hospital were more than death in-hospital.
Therefore, the data cannot actually reflect China's mortality rate of PICU.
The reason analysis was limited to the cause of the disease, and does not take the social, economic factors into account.
This study include eight PICUs of children's Hospital PICU.
Critically ill patients are prospectively studied from death risk factors, admission status, disease diagnosis, severity of illness, analyzing of the risk factors of death from disease diagnosis and death risk factors.
In addition, we will illuminate the relationship of death and economic factor, especially for who died out-hospital after withdraw or stop treatment.
Study Overview
Study Type
Observational
Enrollment (Actual)
5000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Shanghai, China
- Children'S Hosptial of Fuan University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
4 weeks to 18 years (ADULT, CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
ALL patients admitted to the PICU of eight study centers
Description
Inclusion Criteria:
- ALL patients admitted to the PICU of eight study centers
Exclusion Criteria:
- Postoperative monitoring of patients with stable hemodynamics
- PCIS score >90 and not up to the United States PICU admission standards
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Pediatric Critical Illness Score(PCIS)
Time Frame: first 24 hours after admission
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first 24 hours after admission
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Pediatric Risk of Mortality score (PRISM III)
Time Frame: 24 hours
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24 hours
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Pediatric logistic organ dysfunction (PELOD) score
Time Frame: 24hour
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24hour
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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all cause mortality
Time Frame: one year
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one year
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: LU guoping, doctor, Children's Hhospital of Fudan University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 1, 2016
Primary Completion (Actual)
July 31, 2017
Study Completion (Actual)
April 1, 2018
Study Registration Dates
First Submitted
October 26, 2016
First Submitted That Met QC Criteria
November 9, 2016
First Posted (Estimate)
November 10, 2016
Study Record Updates
Last Update Posted (Actual)
April 10, 2018
Last Update Submitted That Met QC Criteria
April 9, 2018
Last Verified
April 1, 2018
More Information
Terms related to this study
Other Study ID Numbers
- fdpicu-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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