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Sepsis Metabolomics

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01649440
Recruitment Status : Completed
First Posted : July 25, 2012
Last Update Posted : January 14, 2014
Information provided by (Responsible Party):
Longxiang Su, Chinese PLA General Hospital

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.

Condition or disease
Normal Control SIRS Sepsis Severe Sepsis Death

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Study Type : Observational
Actual Enrollment : 65 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Systemic Metabolic Changes of Sepsis Patients Revealed by an LC-MS/MS Based Metabolomic Approach
Study Start Date : July 2010
Actual Primary Completion Date : March 2012
Actual Study Completion Date : March 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis

Normal control
Healthy volunteers
  1. temperature >38 ℃ or <36℃;
  2. pulse rate>90 beats/min;
  3. ventilatory rate>20 breaths/min or hyperventilation with partial pressure of arterial carbon dioxide (PaCO2)<32mmHg;
  4. white blood cell count>12,000μL-1 or <4000μL-1 or >10% immature cells
sepsis is defined as SIRS plus confirmed infection.
severe sepsis
  1. sepsis associated with organ dysfunction, hypoperfusion, or hypotension.
  2. sepsis with arterial hypotension, despite adequate fluid resuscitation.
sepsis patients within 48 hours before death.

Primary Outcome Measures :
  1. death [ Time Frame: sepsis patients within 48 hours before death ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
All subjects were selected from among inpatients who were hospitalized between July 2010 and Mar 2012 in the Respiratory ICU, Surgical ICU, and Emergency ICU, Chinese People's Liberation Army (CPLA) General Hospital.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01649440

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China, Beijing
Chinese PLA General Hospital
Beijing, Beijing, China, 100853
Sponsors and Collaborators
Chinese PLA General Hospital
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Study Director: Lixin Xie, Dr Department of Respiratory Diseases, Chinese PLA General Hospital
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Longxiang Su, Dr, Chinese PLA General Hospital Identifier: NCT01649440    
Other Study ID Numbers: CPLAGH-2012023(1)
First Posted: July 25, 2012    Key Record Dates
Last Update Posted: January 14, 2014
Last Verified: January 2014
Keywords provided by Longxiang Su, Chinese PLA General Hospital:
Additional relevant MeSH terms:
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Systemic Inflammatory Response Syndrome
Pathologic Processes