Immunity in Critical Sepsis

Summary

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.

Conditions

• Sepsis

Interventions

OTHER

Individualized anti-infective therapy

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.

OTHER

Individualized immunomodulatory therapy

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.

OTHER

Individualized organ function support therapy

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.

OTHER

Standardized ICU nursing care strategies

Nursing care measures (e.g., protocolized sedation/analgesia management, glycemic control, pressure injury prevention, early mobilization) delivered according to unit-based standardized nursing protocols.

Sponsors & Collaborators

• The People's Hospital of Hebei Province

  collaborator OTHER

• Tianjin First Central Hospital

  collaborator OTHER

• Second Hospital of Shanxi Medical University

  collaborator OTHER

• Beijing Obstetrics and Gynecology Hospital

  collaborator OTHER

• Affiliated Hospital of Hebei University

  collaborator OTHER

• Hebei Provincial Hospital of Traditional Chinese Medicine

  collaborator OTHER_GOV

• Hangzhou Hospital of Traditional Chinese Medicine

  collaborator OTHER

• Baoding First Central Hospital

  collaborator OTHER

• Beijing Shuyi Hospital

  collaborator OTHER

• Cangzhou Central Hospital

  collaborator OTHER

• Hengshui People's Hospital

  collaborator OTHER

• General Hospital of Taiyuan Iron & Steel Company

  collaborator UNKNOWN

• Changzhi People's Hospital

  collaborator OTHER

• Jincheng People's Hospital

  collaborator OTHER

• Xinxiang Central Hospital

  collaborator OTHER

• Luohe Central Hospital

  collaborator OTHER

• Inner Mongolia Baogang Hospital

  collaborator OTHER

• Tianjin Medical University Cancer Institute and Hospital

  collaborator OTHER

• Beijing Chao Yang Hospital

  lead OTHER

Study Design

Allocation

NON_RANDOMIZED

Purpose

OTHER

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-06-30

Primary Completion

2031-06-30

Completion

2031-06-30

Countries

• China

Study Locations