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Completed

NCT Number: NCT05640037

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • anuria
  • ICU readmission in 28 days

Treatment and study plan

Primary outcomes

  1. 28-day all-cause mortality

    Time frame: 28 day

    Number of patients who were confirmed to be dead within 28-day from enrollment onto the study

Secondary outcomes

  1. ICU all-cause mortality

    Time frame: 28 day

    Number of patients who were confirmed to be dead in ICU from enrollment onto the study

  2. ICU length of stay

    Time frame: 28 day

    Length of intensive care unit stay

  3. Hospital length of stay

    Time frame: 28day

    Length of hospital stay

Sponsors and collaborators

Lead sponsor

Zhongnan Hospital

Other

Registry information

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Dec 7, 2022
Registry last updated
May 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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