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Metabonomics Fingerprinting of Multiple Trauma

This study has been completed.
Sponsor:
Information provided by:
Sichuan Academy of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01279239
First received: January 14, 2011
Last updated: July 26, 2011
Last verified: July 2011

January 14, 2011
July 26, 2011
June 2010
June 2011   (final data collection date for primary outcome measure)
Mortality at hospitalization [ Time Frame: Death events from admission to discharge(up to 10 weeks) ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01279239 on ClinicalTrials.gov Archive Site
Multi Organ Failure(MOF) [ Time Frame: MOF events occurence from admission to discharge(up to 10 weeks) ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Metabonomics Fingerprinting of Multiple Trauma
Establishing 1H Nuclear Magnetic Resonance (NMR) Based Metabonomics Fingerprinting Profile for Severe Poly Trauma Patients

The aim of this study is to establish plasma metabonomics fingerprinting atlas for severe multiple trauma patient using 1H nuclear magnetic resonance (NMR) based metabonomics methodology and advanced mathematics tools.

Metabonomics is a set of measurements of the dynamic metabolic responses of living systems to stimuli or modifications. This field of study developed from the application of nuclear magnetic resonance (NMR) spectroscopy and mass spectrometry as tools for the study of complex biofluids. Metabonomics is one of the emerging fields of systemic biology researches concerned with the high-throughput identification, quantification and characterization of small molecule metabolites. A metabonomics fingerprinting can be defined as the complete complement of all small molecule (<1500 Da) metabolites found in a specific cell, body fluid, organ or organism.

Severe poly trauma involves complex injuries that consist of multiple pathological mechanisms involving cytotoxic, oxidation stress and immune-endocrine. The complexity of the pathological physiology and biochemistry process are determined not only by the initial mechanical assault, but also by secondary processes including abnormality of inflammation regulation, ischemia, anoxia, free-radical formation, and immune dysfunction that occur over hours and days following the injury. For the clinical perspective, one of the key difficulties is to identify the most at-risk patients who could develop multiple organ failures and consequently death.

This study aims to establish the dynamics of NMR-based metabonomics fingerprinting of severe multi-trauma patients in order to provide a possible multiple organs failure (MOF) or death event prediction.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

Plasma from peripheral blood.

Non-Probability Sample

Patients who are suffering from poly trauma.

Trauma
Not Provided
  • Poly trauma
    20 Patients suffering from poly trauma who meet inclusion criteria would be recruited
  • Healthy control
    20 healthy volunteers would be recruited to obtain basal metabonomics fingerprinting
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
June 2011
June 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age:18-50 years
  • Poly trauma
  • Injury Severity Score (ISS)>16 and Acute Physiology And Chronic Health Evaluation(APACHE)II>10

Exclusion Criteria:

  • With comorbidity (Diabetes,Hyperthyroidism or primary organ dysfunction )
  • Pregnancy
Both
18 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01279239
META-LAB-10-07-003C-02
No
Hua Jiang/Deputy Chief Surgeon, Sichuan Academy of Medical Sciences, Sichuan Provincial People's Hospital
Sichuan Academy of Medical Sciences
Not Provided
Study Chair: Hua Jiang, M.D Sichuan Academy of Medical Sciences
Principal Investigator: Zhi-Yuan Zhou, M.S Sichuan Academy of Medical Sciences
Principal Investigator: Ming-Wei Sun, M.D Sichuan Academy of Medical Sciences
Sichuan Academy of Medical Sciences
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP