A Prospective Observational Study of Sepsis

A Prospective Observational Study of Clinical Efficacy, Complications, and Prognosis in Patients With Sepsis in ICU

Sepsis is a life-threatening organ dysfunction caused by a dysregulated host response to infection and is associated with high morbidity and mortality. Sepsis3 gives sepsis a broad definition, reflecting the heterogeneity of the disease. So we need a precise treatment with a stratification of patient prognosis in order to reduce mortality in patients with sepsis.

Study Overview

• Status: Recruiting
• Conditions: Sepsis
• Intervention / Treatment: Other: no intervention

• Study Type: Observational
• Enrollment (Anticipated): 174

Contacts and Locations

• Study Contact: Name: Yuewei Li; Phone Number: 020-81332587; Email: liyw7@mail2.sysu.edu.cn

Study Locations

• China
  • Guangzhou, China
    • Recruiting
    • Sun Yat-sen Memorial Hospital of Sun Yat-sen University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients who were hospitalized in the ICU of Sun Yat-sen Memorial Hospital of Sun Yat-sen University and met the Sepsis 3 diagnostic criteria.

Description

Inclusion Criteria:

• Patients who met the Sepsis3 diagnostic criteria.

Exclusion Criteria:

• Absence of laboratory test items (blood routine examination, coagulation function, liver function, biochemistry, urine routine examination, urine renal function, urine protein, etc.) >20%.
• Admission in ICU less than 48 hours.
• Patient with psychiatric disorders.
• Under 18 years of age.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
high exposure level; Patients have a high level of exposure factors	Other: no intervention; no intervention
low exposure level; Patients have a low level of exposure factors	Other: no intervention; no intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
mortality rate	all-cause deaths that occurred in 28 days	28 days after diagnosis of sepsis

Collaborators and Investigators

• Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Study record dates

Study Major Dates

• Study Start (Actual): May 12, 2022
• Primary Completion (Anticipated): May 1, 2023
• Study Completion (Anticipated): June 1, 2023

Study Registration Dates

• First Submitted: March 30, 2022
• First Submitted That Met QC Criteria: March 30, 2022
• First Posted (Actual): April 4, 2022

Study Record Updates

• Last Update Posted (Actual): May 31, 2022
• Last Update Submitted That Met QC Criteria: May 25, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis; Toxemia
• Other Study ID Numbers: SYSEC-KY-KS-2022-009

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No