Vitamin A Status in Critically Ill Children With Sepsis and Its Association With Illness Severity
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|ClinicalTrials.gov Identifier: NCT03598127|
Recruitment Status : Recruiting
First Posted : July 25, 2018
Last Update Posted : July 25, 2018
|Condition or disease|
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.
|Study Type :||Observational|
|Estimated Enrollment :||300 participants|
|Official Title:||Vitamin A Status in Critically Ill Children With Sepsis and Its Association With Illness Severity|
|Actual Study Start Date :||June 1, 2018|
|Estimated Primary Completion Date :||June 1, 2019|
|Estimated Study Completion Date :||June 1, 2019|
patients of sepsis group are diagnosed with sepsis according to International Pediatric Sepsis Consensus Conference:Definitions for sepsis and organ dysfunction in pediatrics.
A gender- and age- matched control group are recruited from among non-sepsis children from Pediatric Intensive Care Unit of West China Hospital.
- Comparison of vitamin A levels between sepsis group and control group,and assessment of VA status in sepsis patients with and without organ dysfunction [ Time Frame: 1 year ]Patients admitting to pediatric intensive care unit (PICU) of West China Hospital and diagnosed with sepsis are recruited according to International Pediatric Sepsis Consensus Conference:Definitions for sepsis and organ dysfunction in pediatrics.A gender- and age- matched control group are recruited from among non-sepsis children. Demographic data(age in months,gender,race,weight in kilograms) are collected form all children for Baseline comparability. VA concentrations of the serum samples measured by mg/dl are analyzed by high-performance liquid chromatography. Then, vitamin A levels of sepsis group will be compared with control group. Laboratory test results (serum creatinine in mmol/L, total bilirubin in mg/dL, PaCO2 in mmHg, and platelet count per mm^3, etc) are collected to identify organ dysfunctions, and VA status of sepsis patients with and without organ dysfunction will be assessed.
- the association between serum vitamin A concentrations and illness severity in children with sepsis [ Time Frame: 1 year ]Severity of illness are measured by Pediatric Index of Mortality (PRISM) scores in the first 24h of admission, and then to investigate the correlation between PRISM scores and A concentrations.
Biospecimen Retention: Samples Without DNA
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03598127
|Contact: Chen Siyuan, Doctor||+86 firstname.lastname@example.org|
|West China Hospital of Sichuan University||Recruiting|
|Chendu, Sichuan, China|
|Contact: Ji Yi, Doctor|