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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02961153
Other study ID # fdpicu-01
Secondary ID
Status Completed
Phase
First received October 26, 2016
Last updated April 9, 2018
Start date August 2016
Est. completion date April 2018

Study information

Verified date April 2018
Source Children's Hospital of Fudan University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 5000
Est. completion date April 2018
Est. primary completion date July 31, 2017
Accepts healthy volunteers No
Gender All
Age group N/A to 18 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
death


Locations

Country Name City State
China Children'S Hosptial of Fuan University Shanghai

Sponsors (1)

Lead Sponsor Collaborator
Children's Hospital of Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pediatric Critical Illness Score(PCIS) first 24 hours after admission
Primary Pediatric Risk of Mortality score (PRISM III) 24 hours
Primary Pediatric logistic organ dysfunction (PELOD) score 24hour
Secondary all cause mortality one year
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