NCT07066553

Brief Summary

Sepsis poses a significant public health challenge in China. However, longitudinal real-world evidence on guideline adherence and patient outcomes remains scarce. This registry aims to address these gaps by systematically capturing guideline-concordant treatment patterns and associated outcomes in ICU patients diagnosed according to Sepsis-3.0 criteria across diverse settings, thereby generating actionable evidence to improve the quality of sepsis care nationwide.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
5,775

participants targeted

Target at P75+ for all trials

Timeline
15mo left

Started Jul 2025

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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 Progress39%
Jul 2025Aug 2027

First Submitted

Initial submission to the registry

June 30, 2025

Completed
15 days until next milestone

First Posted

Study publicly available on registry

July 15, 2025

Completed
3 days until next milestone

Study Start

First participant enrolled

July 18, 2025

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2027

Last Updated

July 15, 2025

Status Verified

July 1, 2025

Enrollment Period

1.1 years

First QC Date

June 30, 2025

Last Update Submit

July 14, 2025

Conditions

Sepsis

Keywords

ChinaSepsisIntensive Care UnitOutcomes

Outcome Measures

Primary Outcomes (1)

  • 28-day all-cause mortality

    28 days after enrollment.

Secondary Outcomes (3)

  • Rate of compliance with sepsis bundle elements

    Patient compliance with sepsis bundles will be assessed within 24 hours after ICU admission.

  • ICU mortality

    From ICU admission to ICU discharge or death, up to 28 days

  • Ventilator-free days

    28 days after enrollment.

Study Arms (1)

Sepsis Group

The sepsis group comprised patients diagnosed with sepsis (Sepsis-3 criteria).

Eligibility Criteria

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

Patients diagnosed with sepsis (Sepsis-3 criteria) upon ICU admission

You may qualify if:

  • Hospitalized patients aged ≥18 years
  • Sepsis diagnosis meeting Sepsis-3 criteria
  • Informed consent signed by patient or legally authorized representative

You may not qualify if:

  • Patients with a prior history of sepsis
  • Sepsis diagnosis \>48 hours prior to enrollment
  • Current participation in clinical trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongda hospital, Southeast University

Nanjing, Jiangsu, 210009, China

Location

Related Publications (3)

  • Xie J, Wang H, Kang Y, Zhou L, Liu Z, Qin B, Ma X, Cao X, Chen D, Lu W, Yao C, Yu K, Yao X, Shang H, Qiu H, Yang Y; CHinese Epidemiological Study of Sepsis (CHESS) Study Investigators. The Epidemiology of Sepsis in Chinese ICUs: A National Cross-Sectional Survey. Crit Care Med. 2020 Mar;48(3):e209-e218. doi: 10.1097/CCM.0000000000004155.

    PMID: 31804299BACKGROUND

  • Rudd KE, Johnson SC, Agesa KM, Shackelford KA, Tsoi D, Kievlan DR, Colombara DV, Ikuta KS, Kissoon N, Finfer S, Fleischmann-Struzek C, Machado FR, Reinhart KK, Rowan K, Seymour CW, Watson RS, West TE, Marinho F, Hay SI, Lozano R, Lopez AD, Angus DC, Murray CJL, Naghavi M. Global, regional, and national sepsis incidence and mortality, 1990-2017: analysis for the Global Burden of Disease Study. Lancet. 2020 Jan 18;395(10219):200-211. doi: 10.1016/S0140-6736(19)32989-7.

    PMID: 31954465BACKGROUND

  • Singer M, Deutschman CS, Seymour CW, Shankar-Hari M, Annane D, Bauer M, Bellomo R, Bernard GR, Chiche JD, Coopersmith CM, Hotchkiss RS, Levy MM, Marshall JC, Martin GS, Opal SM, Rubenfeld GD, van der Poll T, Vincent JL, Angus DC. The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA. 2016 Feb 23;315(8):801-10. doi: 10.1001/jama.2016.0287.

    PMID: 26903338BACKGROUND

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Professor Liu Songqiao

CONTACT

+86 25 83262553liusongqiao@ymail.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
28 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof

Study Record Dates

First Submitted

June 30, 2025

First Posted

July 15, 2025

Study Start

July 18, 2025

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

August 1, 2027

Last Updated

July 15, 2025

Record last verified: 2025-07

Locations

CN(1)