Clinical trial NCT01279239: Metabonomics Fingerprinting of Multiple Trauma
Official title: Establishing 1H Nuclear Magnetic Resonance (NMR) Based Metabonomics Fingerprinting Profile for Severe Poly Trauma Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Trauma
Keywords: Poly Trauma
Metabonomics
NMR
MOF
Lead sponsor: Sichuan Academy of Medical Sciences
Sponsor class: OTHER
First posted: 2011-01-19
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who are suffering from poly trauma.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Mortality at hospitalization
timeFrame: Death events from admission to discharge(up to 10 weeks)
Secondary outcomes:
measure: Multi Organ Failure(MOF)
timeFrame: MOF events occurence from admission to discharge(up to 10 weeks)
Other outcomes:
Locations:
city: Chengdu
country: China
facility: Sichuan Academy of Medical Sciences, Sichuan Provincial Hospital, Dept. Trauma Surgery
state: Sichuan
Study officials:
affiliation: Sichuan Academy of Medical Sciences
name: Hua Jiang, M.D
role: STUDY_CHAIR
affiliation: Sichuan Academy of Medical Sciences
name: Zhi-Yuan Zhou, M.S
role: PRINCIPAL_INVESTIGATOR
affiliation: Sichuan Academy of Medical Sciences
name: Ming-Wei Sun, M.D
role: PRINCIPAL_INVESTIGATOR
References: