NCT02961153

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
5,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2016

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

August 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 26, 2016

Completed
15 days until next milestone

First Posted

Study publicly available on registry

November 10, 2016

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2017

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2018

Completed
Last Updated

April 10, 2018

Status Verified

April 1, 2018

Enrollment Period

12 months

First QC Date

October 26, 2016

Last Update Submit

April 9, 2018

Conditions

Outcome Measures

Primary Outcomes (3)

  • Pediatric Critical Illness Score(PCIS)

    first 24 hours after admission

  • Pediatric Risk of Mortality score (PRISM III)

    24 hours

  • Pediatric logistic organ dysfunction (PELOD) score

    24hour

Secondary Outcomes (1)

  • all cause mortality

    one year

Interventions

deathOTHER

Eligibility Criteria

Age29 Days - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

ALL patients admitted to the PICU of eight study centers

You may qualify if:

  • ALL patients admitted to the PICU of eight study centers

You may not qualify if:

  • Postoperative monitoring of patients with stable hemodynamics
  • PCIS score \>90 and not up to the United States PICU admission standards

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children'S Hosptial of Fuan University

Shanghai, China

Location

MeSH Terms

Interventions

Death Domain

Intervention Hierarchy (Ancestors)

Death Domain SuperfamilyProtein Interaction Domains and MotifsProtein DomainsProtein Structural ElementsProtein ConformationMolecular ConformationMolecular StructureBiochemical PhenomenaChemical Phenomena

Study Officials

  • LU guoping, doctor

    Children's Hhospital of Fudan University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of pediatric Emergency and Critical Care Center. Children's Hospital Fudan University;Director of AHA Training Center for pediatric life support. Children's Hospital Fudan University

Study Record Dates

First Submitted

October 26, 2016

First Posted

November 10, 2016

Study Start

August 1, 2016

Primary Completion

July 31, 2017

Study Completion

April 1, 2018

Last Updated

April 10, 2018

Record last verified: 2018-04

Data Sharing

IPD Sharing
Will not share

Locations