Outcomes of Sepsis Patients in China (CHINA-SEP)
ConditionSepsis
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorSoutheast University, China
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Hospitalized patients aged ≥18 years
Sepsis diagnosis meeting Sepsis-3 criteria
Informed consent signed by patient or legally authorized representative
Disqualifiers
Patients with a prior history of sepsis
Sepsis diagnosis >48 hours prior to enrollment
Current participation in clinical trial
Trial population
Patients diagnosed with sepsis (Sepsis-3 criteria) upon ICU admission
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
5,775 Participants
are grouped into 1 trial groupGroup A: Sepsis Group
Trial outcomes
Primary outcomes
1
28-day all-cause mortality
Time frame
28 days after enrollment.Secondary outcomes
1
Rate of compliance with sepsis bundle elements
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.
Time frame
Patient compliance with sepsis bundles will be assessed within 24 hours after ICU admission.2
ICU mortality
Time frame
From ICU admission to ICU discharge or death, up to 28 days3
Ventilator-free days
Time frame
28 days after enrollment.Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: