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Vitamin A Status in Critically Ill Children With Sepsis and Its Association With Illness Severity

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03598127
Recruitment Status : Recruiting
First Posted : July 26, 2018
Last Update Posted : April 8, 2021
Information provided by (Responsible Party):
Yi Ji, West China Hospital

Brief 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.

Condition or disease

Detailed 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.

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
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 : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis Vitamin A
Drug Information available for: Vitamin A

sepsis group
patients of sepsis group are diagnosed with sepsis according to International Pediatric Sepsis Consensus Conference:Definitions for sepsis and organ dysfunction in pediatrics.
control group
A gender- and age- matched control group are recruited from among non-sepsis children from Pediatric Intensive Care Unit of West China Hospital.

Primary Outcome Measures :
  1. 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 ]
    Demographic data(age in months, gender, race, weight in kilograms) are collected. VA concentrations of the serum samples measured by mg/dl are analyzed by high-performance liquid chromatography. 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.

Secondary Outcome Measures :
  1. 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 Risk of Mortality (PRISM) scores, and to investigate the correlation between PRISM scores and A concentrations.

  2. Performance of PRISM in predicting mortality in pediatric intensive care units in Chinese population. [ Time Frame: 1 year ]
    The PRISM scores are accrued from most abnormal values of 14 physiology variables in the first 24h of admission. The minimum score is 0, and maximum is 76 which is almost invariably associated with death.

  3. Performance of PIM2 in predicting mortality [ Time Frame: 1 year ]
    The index of PIM2 are calculate with 10 variables in the fist 1h of admission, and the index is transferred to probability of death.

  4. Performance of PELOD-2 in predicting mortality [ Time Frame: 1 year ]
    The PELOD-2 score include 10 variables, each variable is ranging from 0 to 6 (some are less than 6). the maximum score is 33 and the minimum is 0. Larger the score means worsen status of a patient.

Biospecimen Retention:   Samples Without DNA
Blood samples are collected from the patients in the first 24h of admission, then the blood samples are centrifuged at 3000 rpm for 5 min to separate the serum.The serum was aliquoted in marked Eppendorf test tubes and frozen at -70℃.

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 192 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients admitted to the pediatric intensive care unit of West China Hospital of Sichuan University are screened and recruited.

Inclusion Criteria:

  • Age ≤16 years old
  • Diagnose of sepsis
  • Consent of both parents (or the person having parental authority in families)

Exclusion Criteria:

  • Discharging against medical advise
  • Age>16 years
  • Condition of underlying chronic disease (hepatic, renal, cardiac,neurological, pulmonary and gastrointestinal)
  • Patients with haematological malignancies and immunodeficiency

(As for evaluating the performance of the three score systems, all patients admitted to the PICU are included except adolescents >16 years of age and those patients who stayed in the PICU for < 2h.)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03598127

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Contact: Chen Siyuan, Doctor +86 02885423453

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China, Sichuan
West China Hospital of Sichuan University Recruiting
Chendu, Sichuan, China
Contact: Ji Yi, Doctor         
Sponsors and Collaborators
West China Hospital
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Yi Ji, Doctor, West China Hospital Identifier: NCT03598127    
Other Study ID Numbers: 2018-333
First Posted: July 26, 2018    Key Record Dates
Last Update Posted: April 8, 2021
Last Verified: April 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yi Ji, West China Hospital:
Vitamin A
illness severity
Additional relevant MeSH terms:
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Systemic Inflammatory Response Syndrome
Pathologic Processes