- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03996759
Early Prediction of Sepsis by Using Metabolomics (EPoS)
Early Prediction of Sepsis by Metabolomic Pofiling in Critically Ill Patients
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
In the past the studies on the prediction and prognosis of sepsis were focused on the levels of protein and gene, and few researches have been done in the field of metabolomics. Actually the changes in the functioning of biological systems can be reflected not only by the specifically expressed protein but also by the metabolism. The metabolic characteristic of biological fluids will be significantly changed when body suffers from pathological or physiological stimulation, and these changes can reveal the disease state or severity while the organ function remains normal due to the compensatory action. Therefore it is possible to predict the occurrence, development and prognosis of sepsis in the early stage through the detection of the concentrations or ratios of these metabolites. The traditional methods are difficult to adapt to the detection of such complicated changes in metabolic profiles when sepsis occurs, thus there is a huge demand of novel means for the metabolic profiling in the inflammatory reaction. By now there have been several researches involved in the metabolic profiling in severe wound, but few have been done in the field of critical care medicine. The metabolic profiles in sepsis patients have remained unclear so far. Therefore it is of great significance to develop a metabolic profiling approach for the measurement and interpretation of the metabolites from the biological samples of sepsis patients and to establish a mode for the metabolomics-based early prediction of sepsis.
Several qualitative and quantitative detection methods will be employed to achieve the goal of metabolic profiling in patients with or without sepsis. Principal Components Analysis (PCA) and Partial Least Squares Discrimination Analysis (PLS-DA) methodology will be applied to understand the metabolic profile. The data will be analyzed by Mestrec and MestReNova software package and the Human Metabolome Database (HMDB) searching to identify the biomarkers for the prediction of sepsis. The biomarkers that changed the most will be verified by Liquid Chromatography-Mass Spectrometry (LC-MS).
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Xi Peng, PhD, MD
- Phone Number: 86-23-68754435
- Email: pxlrmm@163.com
Study Locations
-
-
Chongqing
-
Chongqing, Chongqing, China, 400038
- Recruiting
- Southwest Hospital
-
Contact:
- Xi Peng, PhD, MD
- Phone Number: 86-23-68754435
- Email: pxlrmm@163.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Critically ill patients
Patients admitted in ICU
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Development of sepsis or not
Time Frame: 28 Days
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Xi Peng, PhD, MD, Southwest Hospital, China
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2018XLC2006
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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