NCT05640037

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
99

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 23, 2022

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

November 25, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 7, 2022

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2024

Completed
Last Updated

May 8, 2024

Status Verified

December 1, 2023

Enrollment Period

2 years

First QC Date

November 25, 2022

Last Update Submit

May 7, 2024

Conditions

Sepsis

Keywords

sepsisinterleukin-37biomarker

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • ICU all-cause mortality

    28 day

  • ICU length of stay

    28 day

  • Hospital length of stay

    28day

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

ICU admission with a suspicion of infection

You may qualify if:

  • 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

You may not qualify if:

  • anuria
  • ICU readmission in 28 days

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

plasm

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Dawei Wang, MD

    Wuhan University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 25, 2022

First Posted

December 7, 2022

Study Start

March 23, 2022

Primary Completion

March 20, 2024

Study Completion

March 20, 2024

Last Updated

May 8, 2024

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)