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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
Sponsor:
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.

Condition or disease
Sepsis

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.


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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 : June 1, 2019
Estimated Study Completion Date : June 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis Vitamin A

Group/Cohort
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 ]
    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.


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 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
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℃.


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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 with the diagnosis of sepsis are recruited from the Department of Pediatric Intensive Care Unit, West China Hospital of Sichuan University.
Criteria

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

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 ClinicalTrials.gov identifier (NCT number): NCT03598127


Contacts
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Contact: Chen Siyuan, Doctor +86 02885423453 siy_chen@163.com

Locations
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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

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Responsible Party: Yi Ji, Doctor, West China Hospital
ClinicalTrials.gov Identifier: NCT03598127     History of Changes
Other Study ID Numbers: 2018-333
First Posted: July 25, 2018    Key Record Dates
Last Update Posted: July 25, 2018
Last Verified: July 2018

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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
status
sepsis
illness severity

Additional relevant MeSH terms:
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Sepsis
Toxemia
Critical Illness
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Disease Attributes
Vitamins
Vitamin A
Retinol palmitate
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Anticarcinogenic Agents
Antineoplastic Agents