Sepsis Metabolomics

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01649440

Enrollment

Registered

2012-07-25

Start date

2010-07-31

Completion date

2012-03-31

Last updated

2014-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Death, Normal Control, Sepsis, Severe Sepsis, SIRS

Keywords

Metabolomics, serum, sepsis, biomarkers

Brief 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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
death	sepsis patients within 48 hours before death

Countries

China

Outcome results