Early Prediction of Sepsis by Using Metabolomics

NCT03996759 | Unknown

• 1 other identifier: 2018XLC2006
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Sepsis is a serious medical condition associated with a high incidence and mortality rate. It is the leading cause of death in ICU worldwide. Nowadays sepsis was redefined as a life-threatening organ dysfunction caused by a dysregulated host response to infection. Despite the progress made in the pathogenesis of sepsis and advances achieved in medical interventions, the management of sepsis remains a challenge for clinicians. The core problem that precludes the promotion in the management of sepsis is the lack of early and precise prediction. The metabolic profiles will be significantly changed when body suffers from sepsis even though the organ function remains normal, thus making it possible to predict sepsis in the early stage through the detection of the metabolites.

Conditions

Sepsis

Keywords

Sepsis; metabolomics; biomarker; prediction; clinical data analysis

Outcome Measures

Primary Outcomes (1)

• Development of sepsis or not

  Dynamic assessment of SOFA score to determine whether sepsis occurs. The clinical criteria for sepsis is suspected or documented infection and an acute increase of ≥2 SOFA points.

  28 Days

Study Arms (1)

Critically ill patients

Patients admitted in ICU

Diagnostic Test: Laboratory diagnostic medicine

Interventions

Laboratory diagnostic medicine DIAGNOSTIC_TEST

Metabolomic profiling and laboratory diagnosis including blood routine examination, liver function, renal function, myocardial enzyme, coagulation, arterial blood gas analysis, C-reactive protein, procalcitonin, B-type natriuretic peptide, myoglobin, lipopolysaccharide, cytokines (TNF-α, IL-1β, IL-6, etc.), immune cell markers (CD3+, CD4+, CD8+, etc.), and stool routine as well as intestinal microecology analysis.

Critically ill patients

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients admitted in ICU.

You may qualify if:

• male and female aged 18-80 years old
• confirmed infection (e.g. pulmonary, urinary, blood, abdominal, and pelvic infection)
• APACHE II ≥15 and SOFA \< 2 within 24 hours of admission
• ICU length of stay ≥ 3 days

You may not qualify if:

• pregnant and/or lactating women
• previously suffered from immune diseases and/or long-term use of glucocorticoids
• chronic renal failure or hemodialysis
• patients who expressly refuse consent
• patient who is undergoing other clinical trials

Sponsors & Collaborators

• Xi Peng: lead

Study Sites (1)

Southwest Hospital

Chongqing, Chongqing Municipality, 400038, China

RECRUITING

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Xi Peng, PhD, MD

  Southwest Hospital, China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xi Peng, PhD, MD

CONTACT

86-23-68754435; pxlrmm@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of Clinical Research Center, Deputy Director of Institute of Burn Research, State Key Laboratory of Trauma, Burns and Combined Injury

Study Record Dates

• First Submitted: June 23, 2019
• First Posted: June 25, 2019
• Study Start: July 10, 2019
• Primary Completion: June 18, 2021
• Study Completion: December 31, 2022
• Last Updated: October 27, 2020

Record last verified: 2020-10

Locations

CN (1)