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Amino Acids Expression Profiling of Patients With Sepsis

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ClinicalTrials.gov Identifier: NCT01818830
Recruitment Status : Unknown
Verified March 2013 by Longxiang Su, Chinese PLA General Hospital.
Recruitment status was:  Active, not recruiting
First Posted : March 27, 2013
Last Update Posted : March 27, 2013
Sponsor:
Information provided by (Responsible Party):
Longxiang Su, Chinese PLA General Hospital

Tracking Information
First Submitted Date March 23, 2013
First Posted Date March 27, 2013
Last Update Posted Date March 27, 2013
Study Start Date March 2012
Estimated Primary Completion Date May 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 23, 2013)
Patients Outcome [ Time Frame: 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.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
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 Amino Acids Expression Profiling of Patients With Sepsis
Official Title Amino Acids Expression Profiling of Patients With Sepsis
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case Control
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population The inpatients were included who were in the intensive care units (ICU) of the Department of Respiratory Disease, the Emergency Department, and the Department of Surgery of the Chinese People's Liberation Army General Hospital from March 2012.
Condition
  • Sepsis
  • Amino Acids
Intervention Not Provided
Study Groups/Cohorts
  • 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.
Publications * Su L, Li H, Xie A, Liu D, Rao W, Lan L, Li X, Li F, Xiao K, Wang H, Yan P, Li X, Xie L. Dynamic changes in amino acid concentration profiles in patients with sepsis. PLoS One. 2015 Apr 7;10(4):e0121933. doi: 10.1371/journal.pone.0121933. eCollection 2015.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: March 23, 2013)
100
Original Estimated Enrollment Same as current
Study Completion Date Not Provided
Estimated Primary Completion Date May 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
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 NCT01818830
Other Study ID Numbers PLAGHHN2013001
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, Doctor Department of Respiratory Diseases, Chinese PLA General Hospital
PRS Account Chinese PLA General Hospital
Verification Date March 2013