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

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine0 sites4,000 target enrollmentJune 1, 2021

ConditionsSepsis

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Sepsis
Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Enrollment: 4000
Primary Endpoint: Sepsis organ function status and survival analysis.
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

June 1, 2021

End Date

September 30, 2022

Last Updated

4 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Responsible Party

Principal Investigator

Shuming Pan

Deputy Dean of Xinhua Hospital, Leader of Emergency Medicine Science Department

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Eligibility Criteria

Inclusion Criteria

•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;
•It is estimated that the patient's ICU stay ≥24 hours;
•Obtain informed consent and sign an informed consent form.

Exclusion Criteria

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

Outcomes

Primary Outcomes

Sepsis organ function status and survival analysis.

Time Frame: 2022.09.30

Safety indicators include: prognosis: mortality, intensive care unit (ICU) treatment time and hospital stay, incidence of nosocomial infections, treatment-related complications.