Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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.
 
ClinicalTrials.gov Identifier: NCT01649440
Recruitment Status : Completed
First Posted : July 25, 2012
Last Update Posted : January 14, 2014
Sponsor:
Information provided by (Responsible Party):
Longxiang Su, Chinese PLA General Hospital

Tracking Information
First Submitted Date July 23, 2012
First Posted Date July 25, 2012
Last Update Posted Date January 14, 2014
Study Start Date July 2010
Actual Primary Completion Date March 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 13, 2014)
death [ Time Frame: sepsis patients within 48 hours before death ]
Original Primary Outcome Measures Not Provided
Change History Complete list of historical versions of study NCT01649440 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Sepsis Metabolomics
Official Title Systemic Metabolic Changes of Sepsis Patients Revealed by an LC-MS/MS Based Metabolomic Approach
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • Normal Control
  • SIRS
  • Sepsis
  • Severe Sepsis
  • Death
Intervention Not Provided
Study 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.
Publications * Su L, Huang Y, Zhu Y, Xia L, Wang R, Xiao K, Wang H, Yan P, Wen B, Cao L, Meng N, Luan H, Liu C, Li X, Xie L. Discrimination of sepsis stage metabolic profiles with an LC/MS-MS-based metabolomics approach. BMJ Open Respir Res. 2014 Dec 10;1(1):e000056. doi: 10.1136/bmjresp-2014-000056. eCollection 2014.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: January 13, 2014)
65
Original Actual Enrollment
 (submitted: July 24, 2012)
70
Actual Study Completion Date March 2012
Actual Primary Completion Date March 2012   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT01649440
Other Study ID Numbers CPLAGH-2012023(1)
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Longxiang Su, Chinese PLA General Hospital
Study Sponsor Chinese PLA General Hospital
Collaborators Not Provided
Investigators
Study Director: Lixin Xie, Dr Department of Respiratory Diseases, Chinese PLA General Hospital
PRS Account Chinese PLA General Hospital
Verification Date January 2014