Sepsis Metabolomics

NCT ID: NCT01649440

Last Updated: 2014-01-14

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 65 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-07-31
• Study Completion Date: 2012-03-31

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.

Conditions

Normal Control; SIRS; Sepsis; Severe Sepsis; Death

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Normal control

Healthy volunteers

No interventions assigned to this group

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

No interventions assigned to this group

sepsis

sepsis is defined as SIRS plus confirmed infection.

No interventions assigned to this group

severe sepsis

1. sepsis associated with organ dysfunction, hypoperfusion, or hypotension.

2. sepsis with arterial hypotension, despite adequate fluid resuscitation.

No interventions assigned to this group

death

sepsis patients within 48 hours before death.

No interventions assigned to this group

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Chinese PLA General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Longxiang Su

Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lixin Xie, Dr

Role: STUDY_DIRECTOR

Department of Respiratory Diseases, Chinese PLA General Hospital

Locations

Chinese PLA General Hospital

Beijing, Beijing Municipality, China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 25553245 (View on PubMed)

Other Identifiers

CPLAGH-2012023(1)

Identifier Type: -

Identifier Source: org_study_id