An interventional study of Individualized anti-infective therapy and Individualized immunomodulatory therapy in Sepsis, sponsored by Beijing Chao Yang Hospital. Enrolling by invitation at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-18.
Sponsored by Beijing Chao Yang Hospital · Not applicable, Interventional, and Other
Sepsis is a life-threatening organ dysfunction caused by a dysregulated host immune response to infection, and remains the leading cause of death in critical care medicine worldwide. According to the 2024 Global Burden of Disease data, there are 48.9 million new cases and 11 million deaths annually worldwide, with 11 million deaths accounting for 19.7% of all global deaths. In China, the incidence of sepsis continues to rise due to population aging, increased invasive procedures, overuse of antimicrobials, the prevalence of multidrug-resistant organisms, and a growing number of patients with chronic diseases. Regional studies indicate that the incidence of sepsis in Chinese ICUs ranges from 15% to 30%, with mortality rates as high as 40% to 60%-far exceeding those in developed countries. Among critically ill patients admitted to the ICU-such as those with severe trauma, major surgery, acute respiratory distress syndrome, severe pancreatitis, and advanced malignancies-hospital-acquired infections leading to secondary sepsis represent the most critical trigger for clinical deterioration, multiple organ dysfunction syndrome (MODS), and death. This creates a vicious cascade of "primary disease exacerbation → nosocomial infection → sepsis → MODS → death", resulting in skyrocketing costs, prolonged hospital stays, and heavy burdens on families and society.To address this challenge, this project aims to: (1) establish the largest and internationally leading multimodal dataset for severe sepsis in China, covering 19 tertiary ICUs nationwide over a 5-year period, with 5,300 critically ill patients including 800 sepsis cases, integrating clinical data, immunological indicators, biomarkers, microbiological data, imaging, longitudinal biospecimens, and long-term follow-up information into a standardized, shareable, and sustainable national sepsis database; (2) systematically elucidate the three core pathophysiological mechanisms of severe sepsis-identifying risk factors, pathogen profiles, antimicrobial resistance patterns, and early warning indicators; revealing the dynamic dysregulation patterns of cellular immunity, humoral immunity, and innate immunity to establish immunophenotyping standards; and clarifying the risk factors, mechanisms, and subtype characteristics of multiple organ injury; (3) foster interdisciplinary collaboration between medical and engineering sciences to develop a series of precision diagnostic and therapeutic tools, including AI-assisted early infection warning systems, rapid immunotyping assays, multi-organ injury prediction models, and individualized prognostic calculators for real-time, accurate, and non-invasive bedside assessment; (4) establish a comprehensive precision management system for sepsis, forming an integrated "prevention-early warning-diagnosis-immunotyping-stratified treatment-prognostic evaluation-rehabilitation" care pathway; (5) drive clinical translation to improve patient outcomes, aiming to reduce ICU sepsis incidence, mortality, and healthcare costs, while improving long-term quality of life, cognitive function, and psychological status of survivors and reducing readmission rates; and (6) build a national-level sepsis research platform and cultivate talent by establishing a nationwide collaborative research network, and training professionals with integrated clinical-research-translational competencies.
Exclusion Criteria:
Other: Individualized anti-infective therapy · Other: Individualized immunomodulatory therapy · Other: Individualized organ function support therapy · Other: Standardized ICU nursing care strategies
Antimicrobial agents (e.g., broad-spectrum or targeted antibiotics, antifungals) selected and adjusted by the attending physician based on suspected/confirmed infection source, culture and susceptibility results, and institutional antimicrobial stewardship protocols.
Immunomodulatory agents (e.g., corticosteroids, intravenous immunoglobulin) administered at the discretion of the attending physician according to the patient's immune/inflammatory status and relevant clinical guidelines.
Organ support measures (e.g., mechanical ventilation, continuous renal replacement therapy, vasoactive agents) initiated and titrated by the treating team based on the patient's evolving organ function status.
Nursing care measures (e.g., protocolized sedation/analgesia management, glycemic control, pressure injury prevention, early mobilization) delivered according to unit-based standardized nursing protocols.
Annual incidence of sepsis in ICU
Number of new sepsis cases (diagnosed by Sepsis-3 criteria) per 1,000 ICU admissions (or per 1,000 patient-days).
Time frame: 90 days after enrollment.
Prevalence of sepsis in ICU
Percentage of ICU admissions meeting Sepsis-3 criteria for sepsis during the study period.
Time frame: 90 days after enrollment
Distribution of infection site (lung/abdominal/bloodstream/urinary tract)
Percentage of patients with infection originating from the lung, abdomen, bloodstream, or urinary tract, respectively.
Time frame: 90 days after enrollment
Distribution of infection type (community-acquired/hospital-acquired/secondary)
Percentage of patients with community-acquired, hospital-acquired, or secondary infection, respectively.
Time frame: 90 days after enrollment
Pathogen distribution (Gram-negative/Gram-positive/fungal)
Percentage of microbiological isolates classified as Gram-negative bacteria, Gram-positive bacteria, or fungi.
Time frame: 90 days after enrollment
Antimicrobial resistance rate (CRE/CRAB/MRSA)
Percentage of isolates identified as carbapenem-resistant Enterobacteriaceae (CRE), carbapenem-resistant Acinetobacter baumannii (CRAB), or methicillin-resistant Staphylococcus aureus (MRSA).
Time frame: 90 days after enrollment
ICU length of stay
Number of days from ICU admission to ICU discharge.
Time frame: Through ICU discharge, up to 90 days
Duration of mechanical ventilation
Number of days on invasive mechanical ventilation.
Time frame: Through 90 days
Duration of vasoactive agent use
Number of days on any vasoactive agent (e.g., norepinephrine, vasopressin, dobutamine, epinephrine).
Time frame: Through 90 days
Duration of renal replacement therapy
Number of days receiving renal replacement therapy (continuous or intermittent).
Time frame: Through 90 days
Daily ICU cost
Average direct cost of ICU care per patient per day, in Chinese Yuan (CNY).
Time frame: Through ICU discharge, up to 90 days
Total hospitalization cost
Total direct cost of hospital care per patient, in Chinese Yuan (CNY), from hospital admission to discharge.
Time frame: Through hospital discharge, up to 90 days
ICU mortality
Percentage of patients who die prior to ICU discharge.
Time frame: Through ICU discharge, an average of 28 days
In-hospital mortality
Percentage of patients who die prior to hospital discharge.
Time frame: Through hospital discharge, up to 90 days
28-day all-cause mortality
Percentage of patients who die from any cause within 28 days of enrollment.
Time frame: 28 days after enrollment
90-day all-cause mortality
Percentage of patients who die from any cause within 90 days of enrollment.
Time frame: 90 days after enrollment
Discriminative Performance of the Infection Risk-Prediction Model
Area under the receiver operating characteristic curve (AUC/C-statistic) of the multivariable model predicting infection occurrence, developed from patient, disease, and treatment-related candidate predictors using Cox regression, LASSO, and propensity score analysis.
Time frame: 90 days after enrollment
Sensitivity and Specificity of the Infection Risk-Prediction Score
Sensitivity and specificity (%) of the infection risk-prediction score at its optimal cutoff value, determined by the Youden index.
Time frame: 90 days after enrollment
Hand Hygiene Compliance Rate
Percentage of observed hand hygiene opportunities performed correctly, per WHO Five Moments guidance.
Time frame: 90 days after enrollment
Catheter Care Bundle Compliance Rate
Percentage of eligible patient-days with full compliance to central line and urinary catheter care bundle elements.
Time frame: 90 days after enrollment
Diagnostic Accuracy of Procalcitonin (PCT)
Area under the receiver operating characteristic curve (AUC) of serum Procalcitonin (PCT) concentration for differentiating infection from non-infection and sepsis from non-sepsis, with corresponding sensitivity, specificity, and optimal cutoff value.
Time frame: At enrollment (baseline), and at 72 hours after enrollment
Diagnostic Accuracy of C-Reactive Protein (CRP)
Area under the receiver operating characteristic curve (AUC) of serum C-Reactive Protein (CRP) concentration for differentiating infection from non-infection and sepsis from non-sepsis, with corresponding sensitivity, specificity, and optimal cutoff value.
Time frame: At enrollment (baseline), and at 72 hours after enrollment
Diagnostic Accuracy of Soluble Triggering Receptor Expressed on Myeloid Cells-1 (sTREM-1)
Area under the receiver operating characteristic curve (AUC) of serum Soluble Triggering Receptor Expressed on Myeloid Cells-1 (sTREM-1) concentration for differentiating infection from non-infection and sepsis from non-sepsis, with corresponding sensitivity, specificity, and optimal cutoff value.
Time frame: At enrollment (baseline), and at 72 hours after enrollment
Diagnostic Accuracy of Presepsin
Area under the receiver operating characteristic curve (AUC) of serum Presepsin concentration for differentiating infection from non-infection and sepsis from non-sepsis, with corresponding sensitivity, specificity, and optimal cutoff value.
Time frame: At enrollment (baseline), and at 72 hours after enrollment
Diagnostic Accuracy of Soluble Urokinase Plasminogen Activator Receptor (suPAR)
Area under the receiver operating characteristic curve (AUC) of serum Soluble Urokinase Plasminogen Activator Receptor (suPAR) concentration for differentiating infection from non-infection and sepsis from non-sepsis, with corresponding sensitivity, specificity, and optimal cutoff value.
Time frame: At enrollment (baseline), and at 72 hours after enrollment
Diagnostic Accuracy of Interleukin-6 (IL-6)
Area under the receiver operating characteristic curve (AUC) of serum Interleukin-6 (IL-6) concentration for differentiating infection from non-infection and sepsis from non-sepsis, with corresponding sensitivity, specificity, and optimal cutoff value.
Time frame: At enrollment (baseline), and at 72 hours after enrollment
Diagnostic Accuracy of Interleukin-8 (IL-8)
Area under the receiver operating characteristic curve (AUC) of serum Interleukin-8 (IL-8) concentration for differentiating infection from non-infection and sepsis from non-sepsis, with corresponding sensitivity, specificity, and optimal cutoff value.
Time frame: At enrollment (baseline), and at 72 hours after enrollment
Diagnostic Accuracy of Pro-Adrenomedullin (Pro-ADM)
Area under the receiver operating characteristic curve (AUC) of serum Pro-Adrenomedullin (Pro-ADM) concentration for differentiating infection from non-infection and sepsis from non-sepsis, with corresponding sensitivity, specificity, and optimal cutoff value.
Time frame: At enrollment (baseline), and at 72 hours after enrollment
AUC of Combined Multi-Parameter Early-Warning Model
Area under the receiver operating characteristic curve of a composite model integrating vital signs (temperature, heart rate, respiratory rate, blood pressure, SpO2), laboratory values, and the biomarkers listed above for early warning of infection.
Time frame: From 24 hours before to 72 hours after infection onset
Diagnostic Accuracy of AI-Based Automated Warning System
Accuracy (%) of a machine-learning-based (random forest, XGBoost, deep learning) automated warning system using electronic medical record data to predict infection onset.
Time frame: From 24 hours before to 72 hours after infection onset
Lead Time of AI-Based Warning System
Time interval, in hours, between the AI system alert and the subsequent clinical diagnosis of infection.
Time frame: Up to 24 hours before clinical diagnosis
Time to First Effective Antibiotic Administration
Time, in hours, from infection recognition to administration of the first in vitro active antibiotic.
Time frame: Within 6 hours of infection onset
Rate of Appropriate Empirical Antibiotic Therapy
Percentage of patients receiving empirical antibiotic therapy subsequently confirmed to be active against the identified pathogen(s).
Time frame: 90 days after enrollment
Rate of Antibiotic Coverage of Resistant Organisms
Percentage of patients with identified multidrug-resistant organisms whose empirical antibiotic regimen provided adequate in vitro coverage.
Time frame: 90 days after enrollment
Antibiotic De-escalation Rate
Percentage of patients whose antibiotic regimen was narrowed (de-escalated) based on culture and susceptibility results.
Time frame: 90 days after enrollment
Duration of Antibiotic Therapy
Number of days of antibiotic treatment administered for the index infection.
Time frame: 90 days after enrollment
Time to Source Control
Time, in hours, from infection recognition to definitive source-control intervention (drainage, debridement, catheter removal, or surgery).
Time frame: 90 days after enrollment
Compliance Rate with SSC Bundle Elements
Percentage of eligible patients/bundle elements for which Surviving Sepsis Campaign bundle elements were completed within the recommended time window.
Time frame: 90 days after enrollment
Total hospital length of stay
Number of days from hospital admission to hospital discharge.
Time frame: Through hospital discharge, up to 90 days
CD3+ T Lymphocyte Count/Percentage
Absolute count (cells/μL) and/or percentage of CD3+ T lymphocytes, measured by flow cytometry.
Time frame: At ICU admission (baseline), at the time of infection diagnosis, at 72 hours after diagnosis, and at 5 days after diagnosis
CD4+ T Lymphocyte Count/Percentage
Absolute count (cells/μL) and/or percentage of CD4+ T lymphocytes, measured by flow cytometry.
Time frame: At ICU admission (baseline), at the time of infection diagnosis, at 72 hours after diagnosis, and at 5 days after diagnosis
CD8+ T Lymphocyte Count/Percentage
Absolute count (cells/μL) and/or percentage of CD8+ T lymphocytes, measured by flow cytometry.
Time frame: At ICU admission (baseline), at the time of infection diagnosis, at 72 hours after diagnosis, and at 5 days after diagnosis
CD4+/CD8+ Ratio
Ratio of CD4+ to CD8+ T lymphocyte counts, calculated from flow cytometry measurements
Time frame: At ICU admission (baseline), at the time of infection diagnosis, at 72 hours after diagnosis, and at 5 days after diagnosis
Regulatory T Cell (Treg) Percentage
Percentage of CD4+CD25+FoxP3+ regulatory T cells among total CD4+ T cells, measured by flow cytometry.
Time frame: At ICU admission (baseline), at the time of infection diagnosis, at 72 hours after diagnosis, and at 5 days after diagnosis
Th1/Th2 Ratio
Ratio of Th1 to Th2 helper T cell subsets, measured by flow cytometry.
Time frame: At ICU admission (baseline), at the time of infection diagnosis, at 72 hours after diagnosis, and at 5 days after diagnosis
Monocyte HLA-DR (mHLA-DR) Expression
Monocyte human leukocyte antigen-DR expression, measured by flow cytometry and reported as mean fluorescence intensity or percentage of HLA-DR-positive monocytes.
Time frame: At ICU admission (baseline), at the time of infection diagnosis, at 72 hours after diagnosis, and at 5 days after diagnosis
Natural Killer (NK) Cell Count/Percentage
Absolute count (cells/μL) and/or percentage of NK cells, measured by flow cytometry.
Time frame: At ICU admission (baseline), at the time of infection diagnosis, at 72 hours after diagnosis, and at 5 days after diagnosis
Absolute Lymphocyte Count
Total lymphocyte count, in cells/μL, measured by complete blood count with differential.
Time frame: At ICU admission (baseline), at the time of infection diagnosis, at 72 hours after diagnosis, and at 5 days after diagnosis
Lymphocyte Apoptosis Rate
Percentage of lymphocytes undergoing apoptosis, measured by flow cytometry (e.g., Annexin V/propidium iodide staining).
Time frame: At ICU admission (baseline), at the time of infection diagnosis, at 72 hours after diagnosis, and at 5 days after diagnosis
Monocyte Phagocytic Index
Percentage of monocytes demonstrating phagocytic activity, measured by flow cytometry-based phagocytosis assay, reported as percentage of phagocytic monocytes (%).
Time frame: At ICU admission (baseline), at the time of infection diagnosis, at 72 hours after diagnosis, and at 5 days after diagnosis
Serum Ferritin Concentration
Serum ferritin concentration, in ng/mL, measured by immunoassay.
Time frame: At ICU admission (baseline), at the time of infection diagnosis, at 72 hours after diagnosis, and at 5 days after diagnosis
Serum IgG Concentration
Serum concentration of IgG, measured by immunoassay (e.g., ELISA or multiplex bead-based assay).
Time frame: At ICU admission (baseline), at the time of infection diagnosis, at 72 hours after diagnosis, and at 5 days after diagnosis
Serum IgA Concentration
Serum concentration of IgA, measured by immunoassay (e.g., ELISA or multiplex bead-based assay).
Time frame: At ICU admission (baseline), at the time of infection diagnosis, at 72 hours after diagnosis, and at 5 days after diagnosis
Serum IgM Concentration
Serum concentration of IgM, measured by immunoassay (e.g., ELISA or multiplex bead-based assay).
Time frame: At ICU admission (baseline), at the time of infection diagnosis, at 72 hours after diagnosis, and at 5 days after diagnosis
Complement C3 Concentration
Serum concentration of C3, measured by immunoassay (e.g., ELISA or multiplex bead-based assay).
Time frame: At ICU admission (baseline), at the time of infection diagnosis, at 72 hours after diagnosis, and at 5 days after diagnosis
Complement C4 Concentration
Serum concentration of C4, measured by immunoassay (e.g., ELISA or multiplex bead-based assay).
Time frame: At ICU admission (baseline), at the time of infection diagnosis, at 72 hours after diagnosis, and at 5 days after diagnosis
Complement C5a Concentration
Serum concentration of C5a, measured by immunoassay (e.g., ELISA or multiplex bead-based assay).
Time frame: At ICU admission (baseline), at the time of infection diagnosis, at 72 hours after diagnosis, and at 5 days after diagnosis
Serum IL-1β Concentration
Serum concentration of IL-1β, measured by immunoassay (e.g., ELISA or multiplex bead-based assay).
Time frame: At ICU admission (baseline), at the time of infection diagnosis, at 72 hours after diagnosis, and at 5 days after diagnosis
Serum IL-2 Concentration
Serum concentration of IL-2, measured by immunoassay (e.g., ELISA or multiplex bead-based assay).
Time frame: At ICU admission (baseline), at the time of infection diagnosis, at 72 hours after diagnosis, and at 5 days after diagnosis
Serum IL-4 Concentration
Serum concentration of IL-4, measured by immunoassay (e.g., ELISA or multiplex bead-based assay).
Time frame: At ICU admission (baseline), at the time of infection diagnosis, at 72 hours after diagnosis, and at 5 days after diagnosis
Serum IL-6 Concentration
Serum concentration of IL-6, measured by immunoassay (e.g., ELISA or multiplex bead-based assay).
Time frame: At ICU admission (baseline), at the time of infection diagnosis, at 72 hours after diagnosis, and at 5 days after diagnosis
Serum IL-8 Concentration
Serum concentration of IL-8, measured by immunoassay (e.g., ELISA or multiplex bead-based assay).
Time frame: At ICU admission (baseline), at the time of infection diagnosis, at 72 hours after diagnosis, and at 5 days after diagnosis
Serum IL-10 Concentration
Serum concentration of IL-10, measured by immunoassay (e.g., ELISA or multiplex bead-based assay).
Time frame: At ICU admission (baseline), at the time of infection diagnosis, at 72 hours after diagnosis, and at 5 days after diagnosis
Serum TNF-α Concentration
Serum concentration of TNF-α, measured by immunoassay (e.g., ELISA or multiplex bead-based assay).
Time frame: At ICU admission (baseline), at the time of infection diagnosis, at 72 hours after diagnosis, and at 5 days after diagnosis
Serum IFN-γ Concentration
Serum concentration of IFN-γ, measured by immunoassay (e.g., ELISA or multiplex bead-based assay).
Time frame: At ICU admission (baseline), at the time of infection diagnosis, at 72 hours after diagnosis, and at 5 days after diagnosis
Pro-/Anti-Inflammatory Cytokine Ratio
Ratio of serum IL-6 to IL-10 concentration, calculated as a composite index of pro- versus anti-inflammatory balance.
Time frame: At ICU admission (baseline), at the time of infection diagnosis, at 72 hours after diagnosis, and at 5 days after diagnosis
Incidence of Immunoparalysis
Percentage of patients with monocyte HLA-DR (mHLA-DR) expression below 8,000 antibodies/cell (measured by quantitative flow cytometry, QuantiBRITE method), indicating immunoparalysis.
Time frame: Through 5 days after enrollment
Duration of Immunoparalysis
Number of days during which mHLA-DR expression remains below the pre-specified immunoparalysis threshold.
Time frame: Through day 5 after enrollment
Time to Onset of Immunoparalysis
Time, in hours, from infection recognition to the first mHLA-DR measurement below the pre-specified immunoparalysis threshold.
Time frame: Within 24 hours after infection onset
Proportion of Patients with Hyperinflammatory Immune Phenotype
Percentage of patients classified as hyperinflammatory phenotype (high IL-6/TNF-α/ferritin, low IL-10, normal CD4+/mHLA-DR) by unsupervised clustering (K-means/latent class analysis/PCA) of the immune parameters listed above.
Time frame: Within 5 days after enrollment
Proportion of Patients with Immunosuppressive Immune Phenotype
Percentage of patients classified as immunosuppressive phenotype (normal IL-6/TNF-α/ferritin, high IL-10, low CD4+, high Treg, low mHLA-DR) by the same clustering method.
Time frame: Within 5 days after enrollment
Proportion of Patients with Mixed Immune Phenotype
Percentage of patients classified as mixed phenotype (concurrently elevated pro- and anti-inflammatory markers) by the same clustering method.
Time frame: Within 5 days after enrollment
Sensitivity and Specificity of Bedside Rapid Immunophenotyping Test
Sensitivity and specificity (%) of a bedside rapid test/scoring tool for immune phenotype classification, benchmarked against the reference clustering-based classification.
Time frame: Within 5 days after enrollment
Time to Complete Bedside Immunophenotyping Test
Time, in minutes, required to obtain a result from the bedside rapid immunophenotyping test.
Time frame: Within 5 days after enrollment
Plasma Angiopoietin-2 (Ang-2) Concentration
Plasma Ang-2 concentration, in pg/mL, measured by immunoassay.
Time frame: At ICU admission (baseline), at the time of sepsis diagnosis, and at 72 hours after sepsis diagnosis
Soluble VCAM-1 Concentration
Serum/plasma soluble vascular cell adhesion molecule-1 concentration, in ng/mL, measured by immunoassay.
Time frame: At ICU admission (baseline), at the time of sepsis diagnosis, and at 72 hours after sepsis diagnosis
VEGF Concentration
Vascular endothelial growth factor concentration, in pg/mL, measured by immunoassay.
Time frame: At ICU admission (baseline), at the time of sepsis diagnosis, and at 72 hours after sepsis diagnosis
Endothelin-1 Concentration
Plasma endothelin-1 concentration, in pg/mL, measured by immunoassay.
Time frame: At ICU admission (baseline), at the time of sepsis diagnosis, and at 72 hours after sepsis diagnosis
DPP3 Concentration
Plasma dipeptidyl peptidase 3 concentration, in ng/mL, measured by immunoassay.
Time frame: At ICU admission (baseline), at the time of sepsis diagnosis, and at 72 hours after sepsis diagnosis
Fibrinogen Concentration
Plasma fibrinogen concentration, in g/L, measured by standard coagulation assay.
Time frame: At ICU admission (baseline), at the time of sepsis diagnosis, and at 72 hours after sepsis diagnosis
Platelet Count
Platelet count, in ×10⁹/L, measured by complete blood count.
Time frame: At ICU admission (baseline), at the time of sepsis diagnosis, and at 72 hours after sepsis diagnosis
Thrombin Time
Thrombin time, in seconds, measured by standard coagulation assay.
Time frame: At ICU admission (baseline), at the time of sepsis diagnosis, and at 72 hours after sepsis diagnosis
Concentration of D-dimer
Plasma D-dimer concentration measured at each specified timepoint, reported in μg/mL (or ng/mL FEU).
Time frame: At ICU admission (baseline), at the time of sepsis diagnosis, and at 72 hours after sepsis diagnosis
Discriminative Performance of Multi-Organ Injury Risk-Prediction Model
Area under the receiver operating characteristic curve (AUC/C-statistic) of the multivariable model predicting multi-organ injury, developed from infection, immune, endothelial, coagulation, and patient/treatment-related candidate predictors using Cox regression, LASSO, and machine learning methods.
Time frame: 90 days after enrollment
Sensitivity and Specificity of Multi-Organ Injury Risk Score
Sensitivity and specificity (%) of the multi-organ injury risk score at its optimal cutoff value.
Time frame: 90 days after enrollment
Composite Multi-Organ Dysfunction Score (MODS-score)
Multi-organ dysfunction assessed by the Marshall Multiple Organ Dysfunction Score (MODS), which evaluates six organ systems (respiratory, renal, hepatic, cardiovascular, hematologic, and neurologic), each scored 0-4, for a total score ranging from 0 (no dysfunction) to 24 (maximum dysfunction). Higher scores indicate more severe multi-organ dysfunction.
Time frame: At ICU admission (baseline), at the time of infection diagnosis, at 72 hours after diagnosis, at 5 days after diagnosis and 90 days after diagnosis
Serum Creatinine Concentration
Serum creatinine concentration, in μmol/L (or mg/dL), measured by standard laboratory assay, reflecting renal function.
Time frame: At ICU admission (baseline), at the time of infection diagnosis, at 72 hours after diagnosis, and at 5 days after diagnosis
Serum Total Bilirubin Concentration
Serum total bilirubin concentration, in μmol/L (or mg/dL), measured by standard laboratory assay, reflecting hepatic function.
Time frame: At ICU admission (baseline), at the time of infection diagnosis, at 72 hours after diagnosis, and at 5 days after diagnosis
Serum Troponin Concentration
Serum concentration of high-sensitivity cardiac troponin T (hs-cTnT) or troponin I (hs-cTnI), measured by standard immunoassay, reported in ng/L (or ng/mL), reflecting myocardial injury.
Time frame: At ICU admission (baseline), at the time of infection diagnosis, at 72 hours after diagnosis, and at 5 days after diagnosis
Serum Lactate Concentration
Serum lactate concentration, in mmol/L, measured by standard laboratory assay.
Time frame: At ICU admission (baseline), at the time of infection diagnosis, at 72 hours after diagnosis, and at 5 days after diagnosis
Serum Syndecan-1 Concentration
Serum syndecan-1 concentration, in ng/mL, measured by immunoassay, reflecting glycocalyx/endothelial injury.
Time frame: At ICU admission (baseline), at the time of infection diagnosis, at 72 hours after diagnosis, and at 5 days after diagnosis
Proportion of Patients per Organ-Injury Subtype
Percentage of patients classified as lung-predominant, kidney-predominant, heart-predominant, coagulation-predominant, or mixed subtype, based on the pattern, mechanism, and severity of organ injury.
Time frame: Within 5 days after enrollment
Rate of Multi-Organ Injury Progression
Percentage of patients demonstrating worsening of organ-specific SOFA sub-score between baseline and 72 hours.
Time frame: From baseline (at infection diagnosis) to 72 hours after diagnosis
Rate of Multi-Organ Injury Reversibility
Percentage of patients demonstrating recovery of organ-specific SOFA sub-score between 72 hours and day 5.
Time frame: From 72 hours after diagnosis to 5 days after diagnosis
Compliance Rate with Lung-Protective Ventilation Strategy
Percentage of mechanically ventilated patients receiving tidal volume ≤8 mL/kg predicted body weight.
Time frame: 90 days after enrollment
Time from AKI Diagnosis to RRT Initiation
Time, in hours, from acute kidney injury diagnosis to initiation of renal replacement therapy.
Time frame: 90 days after enrollment
Lactate Clearance Rate
Percentage change in serum lactate concentration from baseline to 72 hours after diagnosis, calculated as (baseline lactate - 72-hour lactate) / baseline lactate × 100%.
Time frame: From baseline (at infection diagnosis) to 72 hours after diagnosis
Discriminative Performance of Prognostic Model for 28-Day Mortality
Area under the receiver operating characteristic curve (AUC/C-statistic) of a prognostic model integrating infection, immune, and organ-injury indicators to predict 28-day all-cause mortality.
Time frame: 28 days after enrollment
Discriminative Performance of Prognostic Model for 90-Day Mortality
Area under the receiver operating characteristic curve (AUC/C-statistic) of the same prognostic model to predict 90-day all-cause mortality.
Time frame: 90 days after enrollment
1-Year All-Cause Survival Rate
Percentage of enrolled patients alive at 1 year after enrollment.
Time frame: 1 year after enrollment
Hospital Readmission Rate
Percentage of patients readmitted to the hospital for any cause within 1 year after enrollment.
Time frame: 1 year after enrollment
Cognitive Function (MoCA)
Cognitive function assessed by the Montreal Cognitive Assessment (MoCA), scored 0-30 (higher scores indicate better cognitive function).
Time frame: 1 year after enrollment
Cognitive Function (TICS)
Cognitive function assessed by the Telephone Interview for Cognitive Status (TICS), scored 0-41, with higher scores indicating better cognitive function.
Time frame: 1 year after enrollment
Anxiety Symptoms (HADS-Anxiety subscale)
Anxiety symptoms assessed by the Hospital Anxiety and Depression Scale, Anxiety subscale (HADS-A), scored 0-21 (higher scores indicate more severe anxiety).
Time frame: 1 year after enrollment
Depressive Symptoms (HADS-Depression subscale)
Depressive symptoms assessed by the Hospital Anxiety and Depression Scale, Depression subscale (HADS-D), scored 0-21 (higher scores indicate more severe depression).
Time frame: 1 year after enrollment
Post-Traumatic Stress Symptoms
Post-traumatic stress symptoms assessed by the PTSD Checklist for DSM-5 (PCL-5), a 20-item self-report measure scored 0-80, with higher scores indicating more severe post-traumatic stress symptoms.
Time frame: 1 year after enrollment
Functional Disability (mRS)
Functional disability assessed by the modified Rankin Scale (mRS), scored 0-6 (higher scores indicate greater disability).
Time frame: 1 year after enrollment
Activities of Daily Living (Barthel Index)
Activities of daily living assessed by the Barthel Index, scored 0-100 (higher scores indicate greater independence).
Time frame: 1 year after enrollment
Muscle Function
Muscle function assessed by the Medical Research Council (MRC) sum score, which evaluates strength in six muscle groups bilaterally (shoulder abductors, elbow flexors, wrist extensors, hip flexors, knee extensors, and ankle dorsiflexors), each scored 0-5, for a total score ranging from 0 (complete paralysis) to 60 (normal strength). Lower scores indicate greater muscle weakness; an MRC sum score \<48 is commonly used to define ICU-acquired weakness.
Time frame: 1 year after enrollment
Health-Related Quality of Life (EQ-5D-5L Utility Index)
Health-related quality of life assessed by the EuroQol 5-Dimension 5-Level (EQ-5D-5L) descriptive system, reported as a utility index value derived using the Chinese value set. The utility index ranges from -0.391 (worst health state) to 1.0 (full health), with higher scores indicating better health-related quality of life. A score of 0 represents a health state equivalent to death, and negative scores represent health states considered worse than death.
Time frame: 1 year after enrollment
Health-Related Quality of Life (EQ-VAS)
Health-related quality of life assessed by the EQ-5D-5L Visual Analogue Scale, scored 0-100 (higher scores indicate better self-rated health).
Time frame: 1 year after enrollment
Concentration of Plasmin-Antiplasmin Complex (PAP)
Plasma PAP complex concentration measured at each specified timepoint, reported in ng/mL.
Time frame: At ICU admission (baseline), at the time of sepsis diagnosis, and at 72 hours after sepsis diagnosis
Concentration of Tissue Plasminogen Activator (tPA)
Plasma tPA concentration measured at each specified timepoint, reported in ng/mL
Time frame: At ICU admission (baseline), at the time of sepsis diagnosis, and at 72 hours after sepsis diagnosis
Concentration of Plasminogen Activator Inhibitor-1 (PAI-1)
Plasma PAI-1 concentration measured at each specified timepoint, reported in ng/mL
Time frame: At ICU admission (baseline), at the time of sepsis diagnosis, and at 72 hours after sepsis diagnosis
Concentration of Fibrin/Fibrinogen Degradation Products (FDP)
Plasma FDP concentration measured at each specified timepoint, reported in μg/mL.
Time frame: At ICU admission (baseline), at the time of sepsis diagnosis, and at 72 hours after sepsis diagnosis
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Beijing Chao Yang Hospital