Sepsis Metabolomics

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Longxiang Su, Chinese PLA General Hospital
ClinicalTrials.gov Identifier:
NCT01649440
First received: July 23, 2012
Last updated: January 13, 2014
Last verified: January 2014
  Purpose

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
Normal Control
SIRS
Sepsis
Severe Sepsis
Death

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Systemic Metabolic Changes of Sepsis Patients Revealed by an LC-MS/MS Based Metabolomic Approach

Resource links provided by NLM:


Further study details as provided by Chinese PLA General Hospital:

Primary Outcome Measures:
  • death [ Time Frame: sepsis patients within 48 hours before death ] [ Designated as safety issue: Yes ]

Enrollment: 65
Study Start Date: July 2010
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Normal control
Healthy volunteers
SIRS
  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
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.
death
sepsis patients within 48 hours before death.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.

Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01649440

Locations
China, Beijing
Chinese PLA General Hospital
Beijing, Beijing, China, 100853
Sponsors and Collaborators
Chinese PLA General Hospital
Investigators
Study Director: Lixin Xie, Dr Department of Respiratory Diseases, Chinese PLA General Hospital
  More Information

No publications provided

Responsible Party: Longxiang Su, Dr, Chinese PLA General Hospital
ClinicalTrials.gov Identifier: NCT01649440     History of Changes
Other Study ID Numbers: CPLAGH-2012023(1)
Study First Received: July 23, 2012
Last Updated: January 13, 2014
Health Authority: China: Ethics Committee

Keywords provided by Chinese PLA General Hospital:
Metabolomics
serum
sepsis
biomarkers

Additional relevant MeSH terms:
Sepsis
Toxemia
Infection
Inflammation
Pathologic Processes
Systemic Inflammatory Response Syndrome

ClinicalTrials.gov processed this record on October 23, 2014