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Enrolling by Invitation

NCT Number: NCT06904001

Study on the Construction and Application of Early Warning Model of Sepsis in Critically Ill Patients

The condition of sepsis patients changes rapidly, whom are often accompanied by impaired respiratory, circulatory, renal, and coagulation functions. So far, the prognosis of sepsis at home and abroad is not ideal. Participants was randomly included in this research project on the pathogenesis and prevention of sepsis due to typical sepsis symptoms. the investigators will collect appropriate clinical specimens for analysis of immune cell functions and pathogenic microorganisms combined with individual patient research. This study will enable sepsis patients to be identified early and receive earlier anti-sepsis treatment, which is expected to improve the prognosis of sepsis, shorten hospitalization time, and reduce treatment costs.

The above-mentioned tests and analyses do not increase the economic burden on the participants, and the required expenses are all paid from the project funds; they do not affect the prognosis and rehabilitation process of participants, and do not have adverse effects on the health of participants.

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Key information

Conditions

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

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, 325000, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Temperature > 38°C or < 36°C;
  • Heart rate > 90 beats/min;
  • Respiratory rate > 20 breaths/min or PaCO₂ < 32 mmHg;
  • White blood cell count > 12.0 × 10⁹/L or < 4.0 × 10⁹/L, or > 10% immature neutrophils;
  • Initial septic shock diagnosis;
  • Organ dysfunction (cardiovascular, respiratory, or ≥ 2 other organs);
  • Complete clinical data.

Exclusion criteria

  • Cancer history;
  • Chemotherapy;
  • Radiotherapy;
  • Incomplete data.
  • Controls were free of infectious or inflammatory diseases and glucocorticoid use.

Treatment and study plan

Primary outcomes

  1. Death

    Time frame: From the date of first ICU admission to the date of ICU discharge (whether due to death or clinical improvement), assessed up to 90 days.

    Whether death occurred during hospitalization

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital of Wenzhou Medical University

Other

Registry information

Acronym: sepsis model

Important dates

Study start
2019
Primary completion
2022
Study completion
2025
First posted
Apr 1, 2025
Registry last updated
Apr 1, 2025

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.

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