Clinical Trial Details
— Status: Recruiting
Administrative data
NCT number |
NCT03598127 |
Other study ID # |
2018-333 |
Secondary ID |
|
Status |
Recruiting |
Phase |
|
First received |
|
Last updated |
|
Start date |
June 1, 2018 |
Est. completion date |
December 31, 2021 |
Study information
Verified date |
April 2021 |
Source |
West China Hospital |
Contact |
Chen Siyuan, Doctor |
Phone |
+86 02885423453 |
Email |
siy_chen[@]163.com |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial Summary
The primary purpose of this study is to assess the status of vitamin A in critically ill
children with sepsis and its association with the ill severity. The second purpose is to
evaluate the performance of three tools in predicting mortality in our population which are
used for measuring the illness severity in pediatric intensive care units.
Description:
Sepsis is a worldwide health problem, resulting in million of deaths each year. Sepsis caused
by infectious diseases is also a common cause of death in children, and infectious diseases
account for more than 50% of the deaths. The prevalence of sepsis and severe sepsis in
children steadily rose in past decade. Although tremendous resources and efforts were
consumed for the disease, the mechanism of sepsis is still unknown. However, sepsis 3.0
recommended that sepsis should be defined as life-threatening organ dysfunction caused by a
dysregulated host response to infection. Study found that sepsis is characterized by a
hyperinflammatory immune response in early phase and suppression of immune system in the
later phase of sepsis. There are 10% of the deaths in the early phase due to overwhelming
inflammation presenting with fever, shock, and multiorgan failure, while 30% of deaths caused
by superinfection occur in the later phase.
Vitamin A, one of lipid soluble vitamins, plays an important role in immune system. Vitamin A
deficiency increases the risk of infection, and vitamin A deficiency is highly prevalent
among children, especially in developing country. Vitamin A is essential for T cells
differentiation, induced regulatory T cells (iTregs) and Th17 cells balance, and
orchestrating immune responses, etc, which contribute to the immune response in patients with
sepsis.Our previous studies revealed that vitamin A deficiency presented in children with
enterovirus 71 (EV71) infection was associated with reduced immunity and more severe
illness.So we hypothesize that vitamin A or vitamin A deficiency may play an essential role
in sepsis. However, data on status of vitamin A or prevalence of vitamin A deficiency in
children with sepsis is limited.We conduct a study to to assess the status of vitamin A in
critically ill children with sepsis and its association with the illness severity.
There are three widely used score systems for measuring the illness severity in pediatric
intensive care units: the pediatric risk of mortality (PRISM), the pediatric index of
mortality (PIM) and the pediatric logistic organ dysfunction (PELOD) score. Though the three
systems are validated in other populations, they are not commonly used in our population
because lack of validation. We will evaluate the performance of the three tools in our
population simultaneously in this study.