Urine Interleukin-37 as a Biomarker of Mortality Risk in Patients With Sepsis

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05640037

Enrollment

Registered

2022-12-07

Start date

2022-03-23

Completion date

2024-03-20

Last updated

2024-05-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sepsis

Keywords

sepsis, interleukin-37, biomarker

Brief summary

This study aims to evaluate the efficacy of IL-37 as a biomarker to predict mortality risk in adults with sepsis.

Detailed description

Sepsis patients admitted in the Department of Critical Care Medicine, Zhongnan Hospital will be included. There are three groups of patients in this study: control group, sepsis group and septic shock group. The interleukin-37 (IL-37) concentration in urine was analyzed in the day 1, 2, 4, 6. Additionally, IL-37 concentration between blood stream infection groups and non-infection groups were analyzed. IL-37 concentration between survivors and non-survivors were also compared. IL-37 concentration were followed from day 1, 2, 4, 6.The correlation between the concentration of IL-37, IL-1β, IL-6、IL-10 and TNF-α were analyzed. Furthermore, the investigators will determine the correlation between the concentration of IL-37, sepsis associated organ dysfunction, 28-day mortality. Lastly, the predictive value of IL-37 to sepsis associated organ dysfunction and prognosis were explored.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

1. Age 18 years or older 2. Expected length of stay\>24 hours in intensive care unit (ICU) 3. Sequential organ failure assessment (SOFA) score ≥ 2 on ICU admission with a suspicion of infection

Exclusion criteria

1. anuria 2. ICU readmission in 28 days

Design outcomes

Primary

Measure	Time frame	Description
28-day all-cause mortality	28 day	Number of patients who were confirmed to be dead within 28-day from enrollment onto the study

Secondary

Measure	Time frame	Description
ICU all-cause mortality	28 day	Number of patients who were confirmed to be dead in ICU from enrollment onto the study
ICU length of stay	28 day	Length of intensive care unit stay
Hospital length of stay	28day	Length of hospital stay

Countries

China

Outcome results