Amino Acids Expression Profiling of Patients With Sepsis

Sponsor
Chinese PLA General Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT01818830
Collaborator
(none)
100
1

Study Details

Study Description

Brief Summary

The patients with sepsis are in the state of hypermetabolism, increased resting energy expenditure, protein and fat catabolism disorder, negative nitrogen balance, insulin resistance, hyperglycemia, and amino acid metabolism disorders. However, it is remain unclear the changes of amino acids expression profiling in sepsis patients. In this study, the investigators has planned to enroll 100 subjects, including 20 cases with systemic inflammatory response syndrome (SIRS), 20 cases with sepsis, 20 cases with severe sepsis and 20 with septic shock. In addition, this study also include 20 normal cases as control. The serum sample of patients with sepsis is draw on days 1, 3, 5, 7, 10, and 14 after first ICU admission. High-performance liquid chromatography and tandem mass spectrometry was used to detect the quantification of amino acids. The amino acids expression profiling contain Arginine, Ornithine, Histidine, Cystine, Isoleucine, Cystathionine, Leucine, Homocystine, Lysine, α-Amino-n-Butyric Acid, Methionine, Alanine, Phenylalanine, Anserine, Threonine, β-Alanine, Tryptophan, β-Amino-Isobutyric Acid, Valine, Carnosine, γ-Amino-n-Butyric Acid, Ethanolamine, Glycine, δ-Hydroxylysine, Serine, Hydroxy-L-Proline, Taurine, 1-Methyl-L-Histidine, Tyrosine, 3-Methyl-L-Mistidine, α-Amino-Adipic, Phospho-Ethanolamine, Asparagine, Phospho-L-Serine, Aspartic acid, Proline, Citrulline, Sarcosine, Glutamic acid, Argininosuccinic Acid, Glutamine, Homocitrulline. The investigators speculate that measurement of amino acids expression profiling could be taken as an indicator for assessment in critically ill patients.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Retrospective
    Official Title:
    Amino Acids Expression Profiling of Patients With Sepsis
    Study Start Date :
    Mar 1, 2012
    Anticipated Primary Completion Date :
    May 1, 2013

    Arms and Interventions

    Arm Intervention/Treatment
    SIRS group

    (1) temperature > 38oC or < 36oC; (2) pulse rate > 90 beats/min; (3) ventilation rate > 20 breaths/min or hyperventilation with a partial pressure of arterial carbon dioxide (PaCO2) < 32 mmHg; (4) white blood cell (WBC) count >1 2,000μL-1 or < 4000 μL-1 , or > 10% immature cells.

    sepsis

    SIRS+infection

    normal control

    For the healthy control outpatients, possibilities of acute or past chronic diseases were excluded. Moreover, we made sure that the healthy control subjects had not been hospitalized or taken vitamin-based substitutive drugs in the last 12 months, and proved normal in physical checkups and lab examinations.

    Outcome Measures

    Primary Outcome Measures

    1. Patients Outcome [28 days]

      The survival time of patients more than 28 days is defined as survival. The survival time of patients less than 28 days is defined as death.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    1. Male and female aged 18 years old and over;

    2. Clinically confirmed infection;

    3. Fulfilled at least two criteria of systemic inflammatory response syndrome (a) core temperature higher than 38 °C or lower than 36 °C (b)respiratory rate above 20/min, or PCO2 below 32 mmHg (c) pulse rate above 90/min, and (d) white blood cell count greater than 12,000/μl or lower than < 4,000/μl or less than 10% of bands.

    Exclusion Criteria:
    1. parenteral nutrition;

    2. diabetes and other metabolic-related diseases;

    3. chronic liver disease;

    4. neutropenia (≤ 500 neutrophils/mm3);

    5. HIV infection;

    6. patients or their relatives refused.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Chinese PLA General Hospital Beijing Beijing China 100853

    Sponsors and Collaborators

    • Chinese PLA General Hospital

    Investigators

    • Study Director: Lixin Xie, Doctor, Department of Respiratory Diseases, Chinese PLA General Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Longxiang Su, Attending Doctor, Chinese PLA General Hospital
    ClinicalTrials.gov Identifier:
    NCT01818830
    Other Study ID Numbers:
    • PLAGHHN2013001
    First Posted:
    Mar 27, 2013
    Last Update Posted:
    Mar 27, 2013
    Last Verified:
    Mar 1, 2013
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 27, 2013