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| Name | Class |
|---|---|
| The People's Hospital of Hebei Province | OTHER |
| Tianjin First Central Hospital | OTHER |
| Second Hospital of Shanxi Medical University | OTHER |
| Beijing Obstetrics and Gynecology Hospital |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sepsis | Incident Sepsis-3.0-defined sepsis/septic shock during ICU admission (SOFA score increase ≥ 2 points in the presence of documented infection) | ||
| Infection without sepsis | Patients with documented infection, SOFA score < 2, and absence of organ injury |
| |
| Non-infectious severe illness | Patients without evidence of infection admitted to the ICU for non-infectious conditions |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Not applicable- observational study | Other | Not applicable- observational study |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 90 days after enrollment. |
| Prevalence of sepsis in ICU | Percentage of ICU admissions meeting Sepsis-3 criteria for sepsis during the study period. | 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. | 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. | 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. | 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). | 90 days after enrollment |
| ICU length of stay |
| Measure | Description | Time Frame |
|---|---|---|
| CD3+ T Lymphocyte Count/Percentage | Absolute count (cells/μL) and/or percentage of CD3+ T lymphocytes, measured by flow cytometry. | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients admitted to the ICU
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Chao Yang Hospital | Beijing | 100020 | China |
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| ID | Term |
|---|---|
| D018805 | Sepsis |
| ID | Term |
|---|---|
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
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| OTHER |
| Affiliated Hospital of Hebei University | OTHER |
| Hebei Provincial Hospital of Traditional Chinese Medicine | OTHER_GOV |
| Hangzhou Hospital of Traditional Chinese Medicine | OTHER |
| Baoding First Central Hospital | OTHER |
| The Hospital of Shunyi District Beijing | UNKNOWN |
| Cangzhou Central Hospital | OTHER |
| Hengshui People's Hospital | OTHER |
| General Hospital of Taiyuan Iron & Steel Company | UNKNOWN |
| Changzhi People's Hospital | OTHER |
| Jincheng People's Hospital | OTHER |
| Xinxiang Central Hospital | OTHER |
| Luohe Central Hospital | OTHER |
| Inner Mongolia Baogang Hospital | OTHER |
| Tianjin Medical University Cancer Institute and Hospital | OTHER |
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Blood samples
Number of days from ICU admission to ICU discharge.
| Through ICU discharge, up to 90 days |
| Total hospital length of stay | Number of days from hospital admission to hospital discharge. | Through hospital discharge, up to 90 days |
| Duration of mechanical ventilation | Number of days on invasive mechanical ventilation. | Through 90 days |
| Duration of vasoactive agent use | Number of days on any vasoactive agent (e.g., norepinephrine, vasopressin, dobutamine, epinephrine). | Through 90 days |
| Duration of renal replacement therapy | Number of days receiving renal replacement therapy (continuous or intermittent). | Through 90 days |
| Daily ICU cost | Average direct cost of ICU care per patient per day, in Chinese Yuan (CNY). | 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. | Through hospital discharge, up to 90 days |
| ICU mortality | Percentage of patients who die prior to ICU discharge. | Through ICU discharge, an average of 28 days |
| In-hospital mortality | Percentage of patients who die prior to hospital discharge. | 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. | 28 days after enrollment |
| 90-day all-cause mortality | Percentage of patients who die from any cause within 90 days of enrollment. | 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. | 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. | 90 days after enrollment |
| Hand Hygiene Compliance Rate | Percentage of observed hand hygiene opportunities performed correctly, per WHO Five Moments guidance. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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). | 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. | 90 days after enrollment |
| Antibiotic De-escalation Rate | Percentage of patients whose antibiotic regimen was narrowed (de-escalated) based on culture and susceptibility results. | 90 days after enrollment |
| Duration of Antibiotic Therapy | Number of days of antibiotic treatment administered for the index infection. | 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). | 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. | 90 days after enrollment |
Absolute count (cells/μL) and/or percentage of CD4+ T lymphocytes, measured by flow cytometry. |
| 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. | 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 | 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. | 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. | 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. | 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. | 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. | 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). | 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 (%). | 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. | 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). | 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). | 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). | 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). | 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). | 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). | 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). | 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). | 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). | 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). | 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). | 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). | 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). | 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). | 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. | 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. | Through 5 days after enrollment |
| Duration of Immunoparalysis | Number of days during which mHLA-DR expression remains below the pre-specified immunoparalysis threshold. | 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. | 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. | 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. | 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. | 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. | 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. | Within 5 days after enrollment |
| Plasma Angiopoietin-2 (Ang-2) Concentration | Plasma Ang-2 concentration, in pg/mL, measured by immunoassay. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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). | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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%. | 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. | 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. | 90 days after enrollment |
| 1-Year All-Cause Survival Rate | Percentage of enrolled patients alive at 1 year after enrollment. | 1 year after enrollment |
| Hospital Readmission Rate | Percentage of patients readmitted to the hospital for any cause within 1 year after enrollment. | 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). | 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. | 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). | 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). | 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. | 1 year after enrollment |
| Functional Disability (mRS) | Functional disability assessed by the modified Rankin Scale (mRS), scored 0-6 (higher scores indicate greater disability). | 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). | 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. | 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. | 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). | 1 year after enrollment |
| Concentration of Plasmin-Antiplasmin Complex (PAP) | Plasma PAP complex concentration measured at each specified timepoint, reported in ng/mL. | 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 | 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 | 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. | At ICU admission (baseline), at the time of sepsis diagnosis, and at 72 hours after sepsis diagnosis |
| D013568 |
| Pathological Conditions, Signs and Symptoms |