Sepsis Metabolomics

Sepsis Clinical Trial

Official title:

Systemic Metabolic Changes of Sepsis Patients Revealed by an LC-MS/MS Based Metabolomic Approach

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01649440
• Other study ID #: CPLAGH-2012023(1)
• Status: Completed
• Phase: N/A
• First received: July 23, 2012
• Last updated: January 13, 2014
• Start date: July 2010
• Est. completion date: March 2012

Study information

• Verified date: January 2014
• Source: Chinese PLA General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Observational

Clinical Trial Summary

The occurrence of sepsis and its relevant multiple organ dysfunction remain a major problem in intensive care units with high morbidity and mortality. The differentiation between non-infectious and infectious etiologies, severity and organ function evaluation, and prognostic assessment are all challenging in routine clinical practice. Many biomarkers have been suggested for these purpose; however sensitivity and specificity even of high-ranking biomarkers still remain insufficient. Recently, metabolic profiling has attracted interest for biomarker discovery. In this study, LC-MS/MS will be perform to identify serum metabolic biomarkers for differentiation of SIRS/sepsis, severity and organ function evaluation, and prognostic assessment among 65 patients. The investigators enrolled 35 patients who were diagnosed with sepsis, 15 patients who were diagnosed with SIRS, and 15 normal patients. Moreover, the sepsis were further divided into sepsis, severe sepsis, and sepsis patients before death. Small metabolites that were present in patient serum samples were measured by LC-MS/MS techniques and analyzed using multivariate statistical methods, such as Principal Component Analysis (PCA), Partial Least Squares-Discriminant Analysis (PLS-DA), and Orthogonal Partial Least Squares Discriminant Analysis. Based on the multivariate statistical analysis above, the investigators could distinguish sepsis from normal and SIRS; distinguish the difference among sepsis, severe sepsis and death. We hypothesis that some metabolites as identified in this study are promising biomarker candidates in the field of sepsis diagnosis and treatment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• male and female aged 18 years old and over;

• clinically confirmed infection;

• fulfilled at least two criteria of systemic inflammatory response syndrome

• core temperature higher than 38 °C or lower than 36 °C

• respiratory rate above 20/min, or PCO2 below 32 mmHg

• pulse rate above 90/min, and

• white blood cell count greater than 12,000/µl or lower than < 4,000/µl or less than 10% of bands.

Exclusion Criteria:

• younger than 18 years of age;

• acquired immunodeficiency syndrome;

• reduced polymorphonuclear granulocyte counts (< 500 µL-1);

• died within 24h after admission into the ICU, or refused to participate in the study, or declined treatment during the period of observation.

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Death
• Normal Control
• Sepsis
• Severe Sepsis
• SIRS
• Toxemia

Locations

Country	Name	City	State
China	Chinese PLA General Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese PLA General Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	death		sepsis patients within 48 hours before death	Yes