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

Status

Enrolling by invitation

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06904001

Acronym

sepsis model

Enrollment

100

Registered

2025-04-01

Start date

2019-01-01

Completion date

2025-12-30

Last updated

2025-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infection, Sepsis, Sepsis and Septic Shock

Keywords

sepsis, septic shock, biomarker, warning model

Brief summary

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 99 Years

Healthy volunteers

Inclusion criteria

1. Temperature \> 38°C or \< 36°C; 2. Heart rate \> 90 beats/min; 3. Respiratory rate \> 20 breaths/min or PaCO₂ \< 32 mmHg; 4. White blood cell count \> 12.0 × 10⁹/L or \< 4.0 × 10⁹/L, or \> 10% immature neutrophils; 5. Initial septic shock diagnosis; 6. Organ dysfunction (cardiovascular, respiratory, or ≥ 2 other organs); 7. Complete clinical data.

Exclusion criteria

1. Cancer history; 2. Chemotherapy; 3. Radiotherapy; 4. Incomplete data. 5. Controls were free of infectious or inflammatory diseases and glucocorticoid use.

Design outcomes

Primary

Measure	Time frame	Description
Death	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

Countries

China

Outcome results