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

NCT06904001 | Enrolling By Invitation DMC

• 1 other identifier: SAHOWMU-CR2018-11-129
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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

Keywords

sepsis; septic shock; biomarker; warning model

Outcome Measures

Primary Outcomes (1)

• Death

  Whether death occurred during hospitalization

  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.

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients admitted to the ICU with sepsis, aged over 18 years.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Second Affiliated Hospital of Wenzhou Medical University: lead

Study Sites (1)

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

Wenzhou, Zhejiang, 325000, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

When admitted to the ICU, 1 ml of whole blood was collected, leukocyte mRNA was extracted, reverse transcribed, and stored in a -80℃ specimen bank.

MeSH Terms

Conditions

Sepsis; Shock, Septic; Infections

Condition Hierarchy (Ancestors)

Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2025
• First Posted: April 1, 2025
• Study Start: January 1, 2019
• Primary Completion: December 30, 2022
• Study Completion: December 30, 2025
• Last Updated: April 1, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)