Intensive Care Units, PediatricNCT02961153
Mortality in Pediatric Intensive Care Unit
An observational study of Intensive Care Units, Pediatric, run by Children's Hospital of Fudan University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 29 days to 18 years
- Conditions the study is for
- Intensive Care Units, Pediatric
- What is being tested?
- death
- How many people
- 5,000 participants
- Where
- 1 siteChina
- Study dates
- Aug 2016to Apr 2018
- 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 29 days to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: ALL patients admitted to the PICU of eight study centers
Who may be able to join
- ALL patients admitted to the PICU of eight study centers
Who cannot join
- Postoperative monitoring of patients with stable hemodynamics
- PCIS score >90 and not up to the United States PICU admission standards
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Intensive Care Units, Pediatric
- Being tested
- death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
deathOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Pediatric Critical Illness Score（PCIS）
Measured: first 24 hours after admission
Pediatric Risk of Mortality score (PRISM III)
Measured: 24 hours
Pediatric logistic organ dysfunction (PELOD) score
Measured: 24hour
Secondary outcomes (1)
all cause mortality
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2016 (estimated)
- Study startAug 2016
- Primary completion31 Jul 2017
- Study completionApr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intensive Care Units, PediatricStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 5,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guoping Lu, Children's Hospital of Fudan University
- Investigators
- LU guoping, doctor, Principal investigator, Children's Hhospital of Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02961153
- Sponsor's protocol ID
- fdpicu-01
- Status last verified
- Apr 2018
- First submitted
- 26 Oct 2016
- Last updated
- 10 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiology of Death in the PICU of Southeast China
- ClinicalTrials.gov ID
- NCT02961153
- Acronym / sponsor ID
- fdpicu-01
- Conditions
- Intensive Care Units, Pediatric
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,000 participants (actual)
- Lead sponsor
- Children's Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- Aug 2016 (actual)
- Primary completion
- 31 Jul 2017 (actual)
- Study completion
- Apr 2018 (actual)
- First posted
- 10 Nov 2016 (estimated)
- 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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 29 days to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- ALL patients admitted to the PICU of eight study centers
Key inclusion criteria (1 listed)
- ALL patients admitted to the PICU of eight study centers
Key exclusion criteria (2 listed)
- Postoperative monitoring of patients with stable hemodynamics
- PCIS score >90 and not up to the United States PICU admission standards
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 |
|---|---|---|
| death | Other | – |
Primary outcome
Pediatric Critical Illness Score（PCIS）
Time frame: first 24 hours after admission
Pediatric Risk of Mortality score (PRISM III)
Time frame: 24 hours
Pediatric logistic organ dysfunction (PELOD) score
Time frame: 24hour
1 secondary outcome
all cause mortality
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2018.
- Individual participant dataSharing planned: No
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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.
LU guoping, doctor principal investigator
Children's Hhospital of Fudan University
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 Intensive Care Units, Pediatric, run by Children's Hospital of Fudan University at 1 site in China.
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 2 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: finished, as of the sponsor's last update on 10 Apr 2018. 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 China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pediatric Critical Illness Score（PCIS） (time frame: first 24 hours after admission). The study lists 3 primary outcomes in all. 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 10 Apr 2018.