SepsisNCT03598127
Vitamin A Status in Critically Ill Children With Sepsis and Its Association With Illness Severity
An observational study of Sepsis, run by West China Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 0 to 192 months
- Conditions the study is for
- Sepsis
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2018to 31 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 192 months
- All sexes
- No healthy volunteers
- Child
Study population: Patients admitted to the pediatric intensive care unit of West China Hospital of Sichuan University are screened and recruited.
Who may be able to join
- Age ≤16 years old
- Diagnose of sepsis
- Consent of both parents (or the person having parental authority in families)
Who cannot join
- 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.)
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
West China Hospital of Sichuan University
Chengdu, Sichuan
Ji Yi, Doctor
About this study
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.
Read the 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
- Keywords
- Vitamin A, status, sepsis, illness severity
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (4)
the association between serum vitamin A concentrations and illness severity in children with sepsis
Severity of illness are measured by Pediatric Risk of Mortality (PRISM) scores, and to investigate the correlation between PRISM scores and A concentrations.
Measured: 1 year
Performance of PRISM in predicting mortality in pediatric intensive care units in Chinese population.
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.
Measured: 1 year
Performance of PIM2 in predicting mortality
The index of PIM2 are calculate with 10 variables in the fist 1h of admission, and the index is transferred to probability of death.
Measured: 1 year
Performance of PELOD-2 in predicting mortality
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2018
- Study start1 Jun 2018
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by West China HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yi Ji, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03598127
- Sponsor's protocol ID
- 2018-333
- Status last verified
- Apr 2021
- First submitted
- 24 Jun 2018
- Last updated
- 8 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 33718302Zhang 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.
PubMed 31370866
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin A Status in Critically Ill Children With Sepsis and Its Association With Illness Severity
- ClinicalTrials.gov ID
- NCT03598127
- Acronym / sponsor ID
- 2018-333
- Conditions
- Sepsis
- Keywords
- Vitamin A, status, sepsis, illness severity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 26 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 0 to 192 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Patients admitted to the pediatric intensive care unit of West China Hospital of Sichuan University are screened and recruited.
Key inclusion criteria (3 listed)
- Age ≤16 years old
- Diagnose of sepsis
- Consent of both parents (or the person having parental authority in families)
Key exclusion criteria (5 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
4 secondary outcomes
the association between serum vitamin A concentrations and illness severity in children with sepsis
Time frame: 1 year
Performance of PRISM in predicting mortality in pediatric intensive care units in Chinese population.
Time frame: 1 year
Performance of PIM2 in predicting mortality
Time frame: 1 year
Performance of PELOD-2 in predicting mortality
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2021.
- Derived from this study: PubMed 33718302Zhang 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.
- Derived from this study: PubMed 31370866Zhang 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis, run by West China Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chen Siyuan, Doctor (+86 02885423453, siy_chen@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03598127, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2021.