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NCT04872010 Clinical Trial

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

Sepsis Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT04872010
Other study ID # SHDC2020CR6030
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date June 1, 2021
Est. completion date September 30, 2022

Study information
Verified date April 2021
Source Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 4000
Est. completion date September 30, 2022
Est. primary completion date September 30, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 1 Year to 100 Years
Eligibility 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

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Outcome
Type Measure Description Time frame Safety issue
Primary Sepsis organ function status and survival analysis. Safety indicators include: prognosis: mortality, intensive care unit (ICU) treatment time and hospital stay, incidence of nosocomial infections, treatment-related complications. 2022.09.30
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