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

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

Study Overview

• Status: Recruiting
• Conditions: 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.

• Study Type: Observational
• Enrollment (Estimated): 120

Contacts and Locations

• Study Contact: Name: Dawei Wang, MD; Phone Number: +8613720256804; Email: wdw_syr@163.com

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China
      • Recruiting
      • Zhongnan Hospital of Wuhan University
      • Contact: Dawei Wang, MD; Phone Number: +8613720256804; Email: wdw_syr@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

ICU admission with a suspicion of infection

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Zhongnan Hospital
• Investigators: Study Chair: Dawei Wang, MD, Wuhan University

Study record dates

Study Major Dates

• Study Start (Actual): March 23, 2022
• Primary Completion (Estimated): July 31, 2024
• Study Completion (Estimated): August 31, 2024

Study Registration Dates

• First Submitted: November 25, 2022
• First Submitted That Met QC Criteria: November 25, 2022
• First Posted (Actual): December 7, 2022

Study Record Updates

• Last Update Posted (Actual): December 22, 2023
• Last Update Submitted That Met QC Criteria: December 21, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: biomarker; sepsis; interleukin-37
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis; Toxemia
• Other Study ID Numbers: Dawei Wang

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No