Study on the Construction and Application of Early Warning Model of Sepsis in Critically Ill Patients (sepsis model)

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.

Study Overview

Status

Enrolling by invitation

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Zhejiang
      • Wenzhou, Zhejiang, China, 325000
        • The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2019

Primary Completion (Actual)

December 30, 2022

Study Completion (Estimated)

December 30, 2025

Study Registration Dates

First Submitted

March 11, 2025

First Submitted That Met QC Criteria

March 30, 2025

First Posted (Actual)

April 1, 2025

Study Record Updates

Last Update Posted (Actual)

April 1, 2025

Last Update Submitted That Met QC Criteria

March 30, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Protecting patient privacy

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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