Sepsis
Conditions
Keywords
China, Sepsis, Intensive Care Unit, Outcomes
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.
Detailed description
Sepsis is a major public health challenge in China and remains one of the leading causes of intensive care unit (ICU) admissions, accounting for approximately 20.6% of all ICU cases. However, longitudinal real-world data on adherence to clinical guidelines and associated patient outcomes remain limited. This multicenter observational registry is designed to systematically capture real-world management data from adult ICU patients diagnosed with sepsis according to Sepsis-3.0 criteria. The study will assess current treatment practices and document infection types, anatomical sites, pathogen profiles, and key clinical outcomes. By examining the relationship between treatment patterns and outcomes, this study aims to generate actionable evidence to improve the quality of sepsis care in China. The findings will help identify practice variability, support updates to national guidelines, and promote standardized, evidence-based management across the country.
Interventions
None listed
Sponsors
Southeast University, China
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Hospitalized patients aged ≥18 years * Sepsis diagnosis meeting Sepsis-3 criteria * Informed consent signed by patient or legally authorized representative
Exclusion criteria
* Patients with a prior history of sepsis * Sepsis diagnosis \>48 hours prior to enrollment * Current participation in clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 28-day all-cause mortality | 28 days after enrollment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ventilator-free days | 28 days after enrollment. | — |
| Rate of compliance with sepsis bundle elements | Patient compliance with sepsis bundles will be assessed within 24 hours after ICU admission. | This outcome quantifies the compliance rate, defined as the proportion of patients who completed all required sepsis bundle elements within the assigned 1-, 3-, or 6-hour window from time zero (time of sepsis recognition). Compliance rate is calculated as the number of patients who completed all clinically indicated bundle elements within the assigned time frame divided by the total number of eligible patients. The bundle elements include serum lactate measurement, blood culture collection prior to antibiotic administration, initiation of intravenous antibiotics, and administration of intravenous crystalloids for patients with hypotension or lactate levels greater than 4 mmol/L. |
| ICU mortality | From ICU admission to ICU discharge or death, up to 28 days | — |
Countries
China
Contacts
Primary ContactProfessor Liu Songqiao
Outcome results
None listed