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Trial record 1 of 1 for:    THREONINE AND GLUTAMIC ACID AND GLYCINE AND HISTIDINE AND PROLINE AND LYSINE AND VALINE AND ASPARTIC ACID AND PHENYLALANINE AND LEUCINE AND ISOLEUCINE AND TRYPTOPHAN AND TYROSINE AND METHIONINE AND TAURINE AND ALANINE AND ARGININE AND SERINE
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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

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
Sepsis Amino Acids

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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis

Group/Cohort
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.



Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01818830


Locations
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China, Beijing
Chinese PLA General Hospital
Beijing, Beijing, China, 100853
Sponsors and Collaborators
Chinese PLA General Hospital
Investigators
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Study Director: Lixin Xie, Doctor Department of Respiratory Diseases, Chinese PLA General Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Longxiang Su, Attending Doctor, Chinese PLA General Hospital
ClinicalTrials.gov Identifier: NCT01818830     History of Changes
Other Study ID Numbers: PLAGHHN2013001
First Posted: March 27, 2013    Key Record Dates
Last Update Posted: March 27, 2013
Last Verified: March 2013

Additional relevant MeSH terms:
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Sepsis
Toxemia
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes