Skip to main content
OpenTrials
Enrolling by Invitation

NCT Number: NCT07707622

Sepsis in Critically Ill Patients

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.

Enrolling by Invitation

Interested in participating?

Request Info

Key information

Conditions

Sepsis Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Beijing Chao Yang Hospital

Beijing, 100020, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 18 years;
  • ICU stay ≥ 24 hours;
  • Informed consent signed by the patient or their legal representative

Exclusion criteria

  • ICU stay < 24 hours;
  • Refusal to provide informed consent;
  • Pregnancy or lactation;
  • Receiving palliative care or expected survival < 24 hours;
  • Previously enrolled in this study;
  • Severe immunodeficiency (HIV infection, or long-term use of corticosteroids/immunosuppressants).

Treatment and study plan

Not applicable- observational study

Other

Not applicable- observational study

Primary outcomes

  1. Annual incidence of sepsis in ICU

    Time frame: 90 days after enrollment.

    Number of new sepsis cases (diagnosed by Sepsis-3 criteria) per 1,000 ICU admissions (or per 1,000 patient-days).

  2. Prevalence of sepsis in ICU

    Time frame: 90 days after enrollment

    Percentage of ICU admissions meeting Sepsis-3 criteria for sepsis during the study period.

  3. Distribution of infection site (lung/abdominal/bloodstream/urinary tract)

    Time frame: 90 days after enrollment

    Percentage of patients with infection originating from the lung, abdomen, bloodstream, or urinary tract, respectively.

  4. Distribution of infection type (community-acquired/hospital-acquired/secondary)

    Time frame: 90 days after enrollment

    Percentage of patients with community-acquired, hospital-acquired, or secondary infection, respectively.

  5. Pathogen distribution (Gram-negative/Gram-positive/fungal)

    Time frame: 90 days after enrollment

    Percentage of microbiological isolates classified as Gram-negative bacteria, Gram-positive bacteria, or fungi.

  6. Antimicrobial resistance rate (CRE/CRAB/MRSA)

    Time frame: 90 days after enrollment

    Percentage of isolates identified as carbapenem-resistant Enterobacteriaceae (CRE), carbapenem-resistant Acinetobacter baumannii (CRAB), or methicillin-resistant Staphylococcus aureus (MRSA).

  7. ICU length of stay

    Time frame: Through ICU discharge, up to 90 days

    Number of days from ICU admission to ICU discharge.

  8. Total hospital length of stay

    Time frame: Through hospital discharge, up to 90 days

    Number of days from hospital admission to hospital discharge.

  9. Duration of mechanical ventilation

    Time frame: Through 90 days

    Number of days on invasive mechanical ventilation.

  10. Duration of vasoactive agent use

    Time frame: Through 90 days

    Number of days on any vasoactive agent (e.g., norepinephrine, vasopressin, dobutamine, epinephrine).

  11. Duration of renal replacement therapy

    Time frame: Through 90 days

    Number of days receiving renal replacement therapy (continuous or intermittent).

  12. Daily ICU cost

    Time frame: Through ICU discharge, up to 90 days

    Average direct cost of ICU care per patient per day, in Chinese Yuan (CNY).

  13. Total hospitalization cost

    Time frame: Through hospital discharge, up to 90 days

    Total direct cost of hospital care per patient, in Chinese Yuan (CNY), from hospital admission to discharge.

  14. ICU mortality

    Time frame: Through ICU discharge, an average of 28 days

    Percentage of patients who die prior to ICU discharge.

  15. In-hospital mortality

    Time frame: Through hospital discharge, up to 90 days

    Percentage of patients who die prior to hospital discharge.

  16. 28-day all-cause mortality

    Time frame: 28 days after enrollment

    Percentage of patients who die from any cause within 28 days of enrollment.

  17. 90-day all-cause mortality

    Time frame: 90 days after enrollment

    Percentage of patients who die from any cause within 90 days of enrollment.

  18. Discriminative Performance of the Infection Risk-Prediction Model

    Time frame: 90 days after enrollment

    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.

  19. Sensitivity and Specificity of the Infection Risk-Prediction Score

    Time frame: 90 days after enrollment

    Sensitivity and specificity (%) of the infection risk-prediction score at its optimal cutoff value, determined by the Youden index.

  20. Hand Hygiene Compliance Rate

    Time frame: 90 days after enrollment

    Percentage of observed hand hygiene opportunities performed correctly, per WHO Five Moments guidance.

  21. Catheter Care Bundle Compliance Rate

    Time frame: 90 days after enrollment

    Percentage of eligible patient-days with full compliance to central line and urinary catheter care bundle elements.

  22. Diagnostic Accuracy of Procalcitonin (PCT)

    Time frame: At enrollment (baseline), and at 72 hours after enrollment

    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.

  23. Diagnostic Accuracy of C-Reactive Protein (CRP)

    Time frame: At enrollment (baseline), and at 72 hours after enrollment

    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.

  24. Diagnostic Accuracy of Soluble Triggering Receptor Expressed on Myeloid Cells-1 (sTREM-1)

    Time frame: At enrollment (baseline), and at 72 hours after enrollment

    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.

  25. Diagnostic Accuracy of Presepsin

    Time frame: At enrollment (baseline), and at 72 hours after enrollment

    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.

  26. Diagnostic Accuracy of Soluble Urokinase Plasminogen Activator Receptor (suPAR)

    Time frame: At enrollment (baseline), and at 72 hours after enrollment

    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.

  27. Diagnostic Accuracy of Interleukin-6 (IL-6)

    Time frame: At enrollment (baseline), and at 72 hours after enrollment

    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.

  28. Diagnostic Accuracy of Interleukin-8 (IL-8)

    Time frame: At enrollment (baseline), and at 72 hours after enrollment

    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.

  29. Diagnostic Accuracy of Pro-Adrenomedullin (Pro-ADM)

    Time frame: At enrollment (baseline), and at 72 hours after enrollment

    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.

  30. AUC of Combined Multi-Parameter Early-Warning Model

    Time frame: From 24 hours before to 72 hours after infection onset

    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.

  31. Diagnostic Accuracy of AI-Based Automated Warning System

    Time frame: From 24 hours before to 72 hours after infection onset

    Accuracy (%) of a machine-learning-based (random forest, XGBoost, deep learning) automated warning system using electronic medical record data to predict infection onset.

  32. Lead Time of AI-Based Warning System

    Time frame: Up to 24 hours before clinical diagnosis

    Time interval, in hours, between the AI system alert and the subsequent clinical diagnosis of infection.

  33. Time to First Effective Antibiotic Administration

    Time frame: Within 6 hours of infection onset

    Time, in hours, from infection recognition to administration of the first in vitro active antibiotic.

  34. Rate of Appropriate Empirical Antibiotic Therapy

    Time frame: 90 days after enrollment

    Percentage of patients receiving empirical antibiotic therapy subsequently confirmed to be active against the identified pathogen(s).

  35. Rate of Antibiotic Coverage of Resistant Organisms

    Time frame: 90 days after enrollment

    Percentage of patients with identified multidrug-resistant organisms whose empirical antibiotic regimen provided adequate in vitro coverage.

  36. Antibiotic De-escalation Rate

    Time frame: 90 days after enrollment

    Percentage of patients whose antibiotic regimen was narrowed (de-escalated) based on culture and susceptibility results.

  37. Duration of Antibiotic Therapy

    Time frame: 90 days after enrollment

    Number of days of antibiotic treatment administered for the index infection.

  38. Time to Source Control

    Time frame: 90 days after enrollment

    Time, in hours, from infection recognition to definitive source-control intervention (drainage, debridement, catheter removal, or surgery).

  39. Compliance Rate with SSC Bundle Elements

    Time frame: 90 days after enrollment

    Percentage of eligible patients/bundle elements for which Surviving Sepsis Campaign bundle elements were completed within the recommended time window.

Secondary outcomes

  1. CD3+ T Lymphocyte Count/Percentage

    Time frame: At ICU admission (baseline), at the time of infection diagnosis, at 72 hours after diagnosis, and at 5 days after diagnosis

    Absolute count (cells/μL) and/or percentage of CD3+ T lymphocytes, measured by flow cytometry.

  2. CD4+ T Lymphocyte Count/Percentage

    Time frame: At ICU admission (baseline), at the time of infection diagnosis, at 72 hours after diagnosis, and at 5 days after diagnosis

    Absolute count (cells/μL) and/or percentage of CD4+ T lymphocytes, measured by flow cytometry.

  3. CD8+ T Lymphocyte Count/Percentage

    Time frame: At ICU admission (baseline), at the time of infection diagnosis, at 72 hours after diagnosis, and at 5 days after diagnosis

    Absolute count (cells/μL) and/or percentage of CD8+ T lymphocytes, measured by flow cytometry.

  4. CD4+/CD8+ Ratio

    Time frame: At ICU admission (baseline), at the time of infection diagnosis, at 72 hours after diagnosis, and at 5 days after diagnosis

    Ratio of CD4+ to CD8+ T lymphocyte counts, calculated from flow cytometry measurements

  5. Regulatory T Cell (Treg) Percentage

    Time frame: At ICU admission (baseline), at the time of infection diagnosis, at 72 hours after diagnosis, and at 5 days after diagnosis

    Percentage of CD4+CD25+FoxP3+ regulatory T cells among total CD4+ T cells, measured by flow cytometry.

  6. Th1/Th2 Ratio

    Time frame: At ICU admission (baseline), at the time of infection diagnosis, at 72 hours after diagnosis, and at 5 days after diagnosis

    Ratio of Th1 to Th2 helper T cell subsets, measured by flow cytometry.

  7. Monocyte HLA-DR (mHLA-DR) Expression

    Time frame: At ICU admission (baseline), at the time of infection diagnosis, at 72 hours after diagnosis, and at 5 days after diagnosis

    Monocyte human leukocyte antigen-DR expression, measured by flow cytometry and reported as mean fluorescence intensity or percentage of HLA-DR-positive monocytes.

  8. Natural Killer (NK) Cell Count/Percentage

    Time frame: At ICU admission (baseline), at the time of infection diagnosis, at 72 hours after diagnosis, and at 5 days after diagnosis

    Absolute count (cells/μL) and/or percentage of NK cells, measured by flow cytometry.

  9. Absolute Lymphocyte Count

    Time frame: At ICU admission (baseline), at the time of infection diagnosis, at 72 hours after diagnosis, and at 5 days after diagnosis

    Total lymphocyte count, in cells/μL, measured by complete blood count with differential.

  10. Lymphocyte Apoptosis Rate

    Time frame: At ICU admission (baseline), at the time of infection diagnosis, at 72 hours after diagnosis, and at 5 days after diagnosis

    Percentage of lymphocytes undergoing apoptosis, measured by flow cytometry (e.g., Annexin V/propidium iodide staining).

  11. Monocyte Phagocytic Index

    Time frame: At ICU admission (baseline), at the time of infection diagnosis, at 72 hours after diagnosis, and at 5 days after diagnosis

    Percentage of monocytes demonstrating phagocytic activity, measured by flow cytometry-based phagocytosis assay, reported as percentage of phagocytic monocytes (%).

  12. Serum Ferritin Concentration

    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, in ng/mL, measured by immunoassay.

  13. Serum IgG Concentration

    Time frame: At ICU admission (baseline), at the time of infection diagnosis, at 72 hours after diagnosis, and at 5 days after diagnosis

    Serum concentration of IgG, measured by immunoassay (e.g., ELISA or multiplex bead-based assay).

  14. Serum IgA Concentration

    Time frame: At ICU admission (baseline), at the time of infection diagnosis, at 72 hours after diagnosis, and at 5 days after diagnosis

    Serum concentration of IgA, measured by immunoassay (e.g., ELISA or multiplex bead-based assay).

  15. Serum IgM Concentration

    Time frame: At ICU admission (baseline), at the time of infection diagnosis, at 72 hours after diagnosis, and at 5 days after diagnosis

    Serum concentration of IgM, measured by immunoassay (e.g., ELISA or multiplex bead-based assay).

  16. Complement C3 Concentration

    Time frame: At ICU admission (baseline), at the time of infection diagnosis, at 72 hours after diagnosis, and at 5 days after diagnosis

    Serum concentration of C3, measured by immunoassay (e.g., ELISA or multiplex bead-based assay).

  17. Complement C4 Concentration

    Time frame: At ICU admission (baseline), at the time of infection diagnosis, at 72 hours after diagnosis, and at 5 days after diagnosis

    Serum concentration of C4, measured by immunoassay (e.g., ELISA or multiplex bead-based assay).

  18. Complement C5a Concentration

    Time frame: At ICU admission (baseline), at the time of infection diagnosis, at 72 hours after diagnosis, and at 5 days after diagnosis

    Serum concentration of C5a, measured by immunoassay (e.g., ELISA or multiplex bead-based assay).

  19. Serum IL-1β Concentration

    Time frame: At ICU admission (baseline), at the time of infection diagnosis, at 72 hours after diagnosis, and at 5 days after diagnosis

    Serum concentration of IL-1β, measured by immunoassay (e.g., ELISA or multiplex bead-based assay).

  20. Serum IL-2 Concentration

    Time frame: At ICU admission (baseline), at the time of infection diagnosis, at 72 hours after diagnosis, and at 5 days after diagnosis

    Serum concentration of IL-2, measured by immunoassay (e.g., ELISA or multiplex bead-based assay).

  21. Serum IL-4 Concentration

    Time frame: At ICU admission (baseline), at the time of infection diagnosis, at 72 hours after diagnosis, and at 5 days after diagnosis

    Serum concentration of IL-4, measured by immunoassay (e.g., ELISA or multiplex bead-based assay).

  22. Serum IL-6 Concentration

    Time frame: At ICU admission (baseline), at the time of infection diagnosis, at 72 hours after diagnosis, and at 5 days after diagnosis

    Serum concentration of IL-6, measured by immunoassay (e.g., ELISA or multiplex bead-based assay).

  23. Serum IL-8 Concentration

    Time frame: At ICU admission (baseline), at the time of infection diagnosis, at 72 hours after diagnosis, and at 5 days after diagnosis

    Serum concentration of IL-8, measured by immunoassay (e.g., ELISA or multiplex bead-based assay).

  24. Serum IL-10 Concentration

    Time frame: At ICU admission (baseline), at the time of infection diagnosis, at 72 hours after diagnosis, and at 5 days after diagnosis

    Serum concentration of IL-10, measured by immunoassay (e.g., ELISA or multiplex bead-based assay).

  25. Serum TNF-α Concentration

    Time frame: At ICU admission (baseline), at the time of infection diagnosis, at 72 hours after diagnosis, and at 5 days after diagnosis

    Serum concentration of TNF-α, measured by immunoassay (e.g., ELISA or multiplex bead-based assay).

  26. Serum IFN-γ Concentration

    Time frame: At ICU admission (baseline), at the time of infection diagnosis, at 72 hours after diagnosis, and at 5 days after diagnosis

    Serum concentration of IFN-γ, measured by immunoassay (e.g., ELISA or multiplex bead-based assay).

  27. Pro-/Anti-Inflammatory Cytokine Ratio

    Time frame: At ICU admission (baseline), at the time of infection diagnosis, at 72 hours after diagnosis, and at 5 days after diagnosis

    Ratio of serum IL-6 to IL-10 concentration, calculated as a composite index of pro- versus anti-inflammatory balance.

  28. Incidence of Immunoparalysis

    Time frame: Through 5 days after enrollment

    Percentage of patients with monocyte HLA-DR (mHLA-DR) expression below 8,000 antibodies/cell (measured by quantitative flow cytometry, QuantiBRITE method), indicating immunoparalysis.

  29. Duration of Immunoparalysis

    Time frame: Through day 5 after enrollment

    Number of days during which mHLA-DR expression remains below the pre-specified immunoparalysis threshold.

  30. Time to Onset of Immunoparalysis

    Time frame: Within 24 hours after infection onset

    Time, in hours, from infection recognition to the first mHLA-DR measurement below the pre-specified immunoparalysis threshold.

  31. Proportion of Patients with Hyperinflammatory Immune Phenotype

    Time frame: Within 5 days after enrollment

    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.

  32. Proportion of Patients with Immunosuppressive Immune Phenotype

    Time frame: Within 5 days after enrollment

    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.

  33. Proportion of Patients with Mixed Immune Phenotype

    Time frame: Within 5 days after enrollment

    Percentage of patients classified as mixed phenotype (concurrently elevated pro- and anti-inflammatory markers) by the same clustering method.

  34. Sensitivity and Specificity of Bedside Rapid Immunophenotyping Test

    Time frame: Within 5 days after enrollment

    Sensitivity and specificity (%) of a bedside rapid test/scoring tool for immune phenotype classification, benchmarked against the reference clustering-based classification.

  35. Time to Complete Bedside Immunophenotyping Test

    Time frame: Within 5 days after enrollment

    Time, in minutes, required to obtain a result from the bedside rapid immunophenotyping test.

  36. Plasma Angiopoietin-2 (Ang-2) Concentration

    Time frame: At ICU admission (baseline), at the time of sepsis diagnosis, and at 72 hours after sepsis diagnosis

    Plasma Ang-2 concentration, in pg/mL, measured by immunoassay.

  37. Soluble VCAM-1 Concentration

    Time frame: At ICU admission (baseline), at the time of sepsis diagnosis, and at 72 hours after sepsis diagnosis

    Serum/plasma soluble vascular cell adhesion molecule-1 concentration, in ng/mL, measured by immunoassay.

  38. VEGF Concentration

    Time frame: At ICU admission (baseline), at the time of sepsis diagnosis, and at 72 hours after sepsis diagnosis

    Vascular endothelial growth factor concentration, in pg/mL, measured by immunoassay.

  39. Endothelin-1 Concentration

    Time frame: At ICU admission (baseline), at the time of sepsis diagnosis, and at 72 hours after sepsis diagnosis

    Plasma endothelin-1 concentration, in pg/mL, measured by immunoassay.

  40. DPP3 Concentration

    Time frame: At ICU admission (baseline), at the time of sepsis diagnosis, and at 72 hours after sepsis diagnosis

    Plasma dipeptidyl peptidase 3 concentration, in ng/mL, measured by immunoassay.

  41. Fibrinogen Concentration

    Time frame: At ICU admission (baseline), at the time of sepsis diagnosis, and at 72 hours after sepsis diagnosis

    Plasma fibrinogen concentration, in g/L, measured by standard coagulation assay.

  42. Platelet Count

    Time frame: At ICU admission (baseline), at the time of sepsis diagnosis, and at 72 hours after sepsis diagnosis

    Platelet count, in ×10⁹/L, measured by complete blood count.

  43. Thrombin Time

    Time frame: At ICU admission (baseline), at the time of sepsis diagnosis, and at 72 hours after sepsis diagnosis

    Thrombin time, in seconds, measured by standard coagulation assay.

  44. Concentration of D-dimer

    Time frame: At ICU admission (baseline), at the time of sepsis diagnosis, and at 72 hours after sepsis diagnosis

    Plasma D-dimer concentration measured at each specified timepoint, reported in μg/mL (or ng/mL FEU).

  45. Discriminative Performance of Multi-Organ Injury Risk-Prediction Model

    Time frame: 90 days after enrollment

    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.

  46. Sensitivity and Specificity of Multi-Organ Injury Risk Score

    Time frame: 90 days after enrollment

    Sensitivity and specificity (%) of the multi-organ injury risk score at its optimal cutoff value.

  47. Composite Multi-Organ Dysfunction Score (MODS-score)

    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

    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.

  48. Serum Creatinine Concentration

    Time frame: At ICU admission (baseline), at the time of infection diagnosis, at 72 hours after diagnosis, and at 5 days after diagnosis

    Serum creatinine concentration, in μmol/L (or mg/dL), measured by standard laboratory assay, reflecting renal function.

  49. Serum Total Bilirubin Concentration

    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, in μmol/L (or mg/dL), measured by standard laboratory assay, reflecting hepatic function.

  50. Serum Troponin Concentration

    Time frame: At ICU admission (baseline), at the time of infection diagnosis, at 72 hours after diagnosis, and at 5 days after diagnosis

    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.

  51. Serum Lactate Concentration

    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, in mmol/L, measured by standard laboratory assay.

  52. Serum Syndecan-1 Concentration

    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, in ng/mL, measured by immunoassay, reflecting glycocalyx/endothelial injury.

  53. Proportion of Patients per Organ-Injury Subtype

    Time frame: Within 5 days after enrollment

    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.

  54. Rate of Multi-Organ Injury Progression

    Time frame: From baseline (at infection diagnosis) to 72 hours after diagnosis

    Percentage of patients demonstrating worsening of organ-specific SOFA sub-score between baseline and 72 hours.

  55. Rate of Multi-Organ Injury Reversibility

    Time frame: From 72 hours after diagnosis to 5 days after diagnosis

    Percentage of patients demonstrating recovery of organ-specific SOFA sub-score between 72 hours and day 5.

  56. Compliance Rate with Lung-Protective Ventilation Strategy

    Time frame: 90 days after enrollment

    Percentage of mechanically ventilated patients receiving tidal volume ≤8 mL/kg predicted body weight.

  57. Time from AKI Diagnosis to RRT Initiation

    Time frame: 90 days after enrollment

    Time, in hours, from acute kidney injury diagnosis to initiation of renal replacement therapy.

  58. Lactate Clearance Rate

    Time frame: From baseline (at infection diagnosis) to 72 hours after diagnosis

    Percentage change in serum lactate concentration from baseline to 72 hours after diagnosis, calculated as (baseline lactate - 72-hour lactate) / baseline lactate × 100%.

  59. Discriminative Performance of Prognostic Model for 28-Day Mortality

    Time frame: 28 days after enrollment

    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.

  60. Discriminative Performance of Prognostic Model for 90-Day Mortality

    Time frame: 90 days after enrollment

    Area under the receiver operating characteristic curve (AUC/C-statistic) of the same prognostic model to predict 90-day all-cause mortality.

  61. 1-Year All-Cause Survival Rate

    Time frame: 1 year after enrollment

    Percentage of enrolled patients alive at 1 year after enrollment.

  62. Hospital Readmission Rate

    Time frame: 1 year after enrollment

    Percentage of patients readmitted to the hospital for any cause within 1 year after enrollment.

  63. Cognitive Function (MoCA)

    Time frame: 1 year after enrollment

    Cognitive function assessed by the Montreal Cognitive Assessment (MoCA), scored 0-30 (higher scores indicate better cognitive function).

  64. Cognitive Function (TICS)

    Time frame: 1 year after enrollment

    Cognitive function assessed by the Telephone Interview for Cognitive Status (TICS), scored 0-41, with higher scores indicating better cognitive function.

  65. Anxiety Symptoms (HADS-Anxiety subscale)

    Time frame: 1 year after enrollment

    Anxiety symptoms assessed by the Hospital Anxiety and Depression Scale, Anxiety subscale (HADS-A), scored 0-21 (higher scores indicate more severe anxiety).

  66. Depressive Symptoms (HADS-Depression subscale)

    Time frame: 1 year after enrollment

    Depressive symptoms assessed by the Hospital Anxiety and Depression Scale, Depression subscale (HADS-D), scored 0-21 (higher scores indicate more severe depression).

  67. Post-Traumatic Stress Symptoms

    Time frame: 1 year after enrollment

    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.

  68. Functional Disability (mRS)

    Time frame: 1 year after enrollment

    Functional disability assessed by the modified Rankin Scale (mRS), scored 0-6 (higher scores indicate greater disability).

  69. Activities of Daily Living (Barthel Index)

    Time frame: 1 year after enrollment

    Activities of daily living assessed by the Barthel Index, scored 0-100 (higher scores indicate greater independence).

  70. Muscle Function

    Time frame: 1 year after enrollment

    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.

  71. Health-Related Quality of Life (EQ-5D-5L Utility Index)

    Time frame: 1 year after enrollment

    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.

  72. Health-Related Quality of Life (EQ-VAS)

    Time frame: 1 year after enrollment

    Health-related quality of life assessed by the EQ-5D-5L Visual Analogue Scale, scored 0-100 (higher scores indicate better self-rated health).

  73. Concentration of Plasmin-Antiplasmin Complex (PAP)

    Time frame: At ICU admission (baseline), at the time of sepsis diagnosis, and at 72 hours after sepsis diagnosis

    Plasma PAP complex concentration measured at each specified timepoint, reported in ng/mL.

  74. Concentration of Tissue Plasminogen Activator (tPA)

    Time frame: At ICU admission (baseline), at the time of sepsis diagnosis, and at 72 hours after sepsis diagnosis

    Plasma tPA concentration measured at each specified timepoint, reported in ng/mL

  75. Concentration of Plasminogen Activator Inhibitor-1 (PAI-1)

    Time frame: At ICU admission (baseline), at the time of sepsis diagnosis, and at 72 hours after sepsis diagnosis

    Plasma PAI-1 concentration measured at each specified timepoint, reported in ng/mL

  76. Concentration of Fibrin/Fibrinogen Degradation Products (FDP)

    Time frame: At ICU admission (baseline), at the time of sepsis diagnosis, and at 72 hours after sepsis diagnosis

    Plasma FDP concentration measured at each specified timepoint, reported in μg/mL.

Sponsors and collaborators

Lead sponsor

Beijing Chao Yang Hospital

Other

Collaborators

  • Affiliated Hospital of Hebei University
  • Baoding First Central Hospital
  • Beijing Obstetrics and Gynecology Hospital
  • Beijing Shuyi Hospital
  • Cangzhou Central Hospital
  • Changzhi People's Hospital
  • General Hospital of Taiyuan Iron & Steel Company
  • Hangzhou Hospital of Traditional Chinese Medicine
  • Hebei Provincial Hospital of Traditional Chinese Medicine
  • Hengshui People's Hospital
  • Inner Mongolia Baogang Hospital
  • Jincheng People's Hospital
  • Luohe Central Hospital
  • Second Hospital of Shanxi Medical University
  • The People's Hospital of Hebei Province
  • Tianjin First Central Hospital
  • Tianjin Medical University Cancer Institute and Hospital
  • Xinxiang Central Hospital

Registry information

Official study title

A Prospective Multicenter Registration Study on Sepsis in Critically Ill Patients

Important dates

Study start
2026
Primary completion
2031
Study completion
2031
First posted
Jul 16, 2026
Registry last updated
Jul 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.