Construction of a Database for the Life-cycle Sepsis-specific Disease Cohort

• Conditions: Sepsis

• Registration Number: NCT04872010
• Lead Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Brief Summary

Establish a structured clinical database for sepsis screening, and establish a special data set standard for sepsis throughout the life cycle.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-04
• Study First Submitted: 2021-04-10
• Study First Submitted QC: 2021-05-02
• Last Update Submitted: 2021-05-02
• Study First Posted: 2021-05-04
• Last Update Posted: 2021-05-04
• Study Start: 2021-06-01
• Primary Completion: 2022-09-30
• Study Completion: 2022-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 4000

Inclusion Criteria

1. Patients with sepsis who meet the Sepsis 3.0 standard proposed by the 2016 International Sepsis Expert Consensus, that is, for patients with infection or suspected infection, when sepsis-related sequential organ failure (Sequential (Sepsis-related) Organ Failure) Assessment (SOFA) score increased by ≥ 2 points from the baseline can be diagnosed as sepsis;
2. It is estimated that the patient's ICU stay ≥24 hours;
3. Obtain informed consent and sign an informed consent form.

Exclusion Criteria

1. The patient's ICU hospital stay is less than 24 hours;
2. Participated in other clinical research;
3. Failed to sign the informed consent form.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sepsis organ function status and survival analysis.	2022.09.30	Safety indicators include: prognosis: mortality, intensive care unit (ICU) treatment time and hospital stay, incidence of nosocomial infections, treatment-related complications.