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

NCT03598127 | Unknown

• 1 other identifier: 2018-333
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Sepsis

Keywords

Vitamin A; status; sepsis; illness severity

Outcome Measures

Primary Outcomes (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

  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.

  1 year

Secondary Outcomes (4)

• the association between serum vitamin A concentrations and illness severity in children with sepsis

  1 year

• Performance of PRISM in predicting mortality in pediatric intensive care units in Chinese population.

  1 year

• Performance of PIM2 in predicting mortality

  1 year

• Performance of PELOD-2 in predicting mortality

  1 year

Study Arms (2)

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.

Eligibility Criteria

• Age: 0 Months - 192 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• West China Hospital: lead

Study Sites (1)

West China Hospital of Sichuan University

Chengdu, Sichuan, China

RECRUITING

Related Publications (2)

• 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.

  PMID: 33718302 DERIVED

• 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.

  PMID: 31370866 DERIVED

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℃.

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Chen Siyuan, Doctor

CONTACT

+86 02885423453; siy_chen@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: June 24, 2018
• First Posted: July 26, 2018
• Study Start: June 1, 2018
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: April 8, 2021

Record last verified: 2021-04

Locations

CN (1)