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NCT05640037 Clinical Trial

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

Sepsis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05640037
Other study ID # Dawei Wang
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 23, 2022
Est. completion date March 20, 2024

Study information
Verified date December 2023
Source Zhongnan Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 99
Est. completion date March 20, 2024
Est. primary completion date March 20, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
China Zhongnan Hospital of Wuhan University Wuhan Hubei

Sponsors (1)
Lead Sponsor Collaborator
Zhongnan Hospital

Country where clinical trial is conducted

China, 

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