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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 : May 13, 2019
Sponsor:
Information provided by (Responsible Party):
Yi Ji, West China Hospital

Tracking Information
First Submitted Date June 24, 2018
First Posted Date July 25, 2018
Last Update Posted Date May 13, 2019
Actual Study Start Date June 1, 2018
Estimated Primary Completion Date June 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 9, 2019)
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.
Original Primary Outcome Measures
 (submitted: July 13, 2018)
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.
Change History Complete list of historical versions of study NCT03598127 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: May 9, 2019)
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures
 (submitted: July 13, 2018)
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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Vitamin A Status in Critically Ill Children With Sepsis and Its Association With Illness Severity
Official Title Vitamin A Status in Critically Ill Children With Sepsis and Its Association With Illness Severity
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.
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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
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℃.
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.
Condition Sepsis
Intervention Not Provided
Study Groups/Cohorts
  • 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: July 13, 2018)
300
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 1, 2019
Estimated Primary Completion Date June 1, 2019   (Final data collection date for primary outcome measure)
Eligibility 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

(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.)

Sex/Gender
Sexes Eligible for Study: All
Ages up to 192 Months   (Child)
Accepts Healthy Volunteers No
Contacts
Contact: Chen Siyuan, Doctor +86 02885423453 siy_chen@163.com
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT03598127
Other Study ID Numbers 2018-333
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Yi Ji, West China Hospital
Study Sponsor West China Hospital
Collaborators Not Provided
Investigators Not Provided
PRS Account West China Hospital
Verification Date May 2019