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

NCT ID: NCT06904001

Last Updated: 2025-04-01

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-01-01
• Study Completion Date: 2025-12-30

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.

Conditions

Sepsis; Sepsis and Septic Shock; Infection

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

sepsis and control

The presence of sepsis at the time of admission to the ICU is called sepsis, and the absence of sepsis is called control.

No interventions assigned to this group

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Second Affiliated Hospital of Wenzhou Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Wenzhou, Zhejiang, China

Countries

China

Other Identifiers

SAHOWMU-CR2018-11-129

Identifier Type: -

Identifier Source: org_study_id