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

NCT ID: NCT03598127

Last Updated: 2021-04-08

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-06-01
• Study Completion Date: 2021-12-31

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.

Conditions

Sepsis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

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.

No interventions assigned to this group

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.)

• Minimum Eligible Age: 0 Months
• Maximum Eligible Age: 192 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

West China Hospital

OTHER

Sponsor Role: lead

Responsible Party

Yi Ji

Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

West China Hospital of Sichuan University

Chengdu, Sichuan, China

Site Status: RECRUITING

Countries

China

Central Contacts

Chen Siyuan, Doctor

Role: CONTACT

siy_chen@163.com

+86 02885423453

Facility Contacts

Ji Yi, Doctor

Role: primary

References

Zhang X, Sun K, Lu G, Feng L, Chen S, Ji Y. Comparison of PICU Cost and Severity-Adjusted Cost Between Patients With SIRS-Defined Sepsis and Those With Age-Adapted SOFA-Defined Sepsis. Front Pediatr. 2021 Feb 25;9:628918. doi: 10.3389/fped.2021.628918. eCollection 2021.

Reference Type: DERIVED

PMID: 33718302 (View on PubMed)

Zhang X, Yang K, Chen L, Liao X, Deng L, Chen S, Ji Y. Vitamin A deficiency in critically ill children with sepsis. Crit Care. 2019 Aug 1;23(1):267. doi: 10.1186/s13054-019-2548-9.

Reference Type: DERIVED

PMID: 31370866 (View on PubMed)

Other Identifiers

2018-333

Identifier Type: -

Identifier Source: org_study_id