- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06904001
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
Conditions
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
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Zhejiang
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Wenzhou, Zhejiang, China, 325000
- The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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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.
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Whether death occurred during hospitalization
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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.
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SAHOWMU-CR2018-11-129
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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