Amino Acids Expression Profiling of Patients With Sepsis
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Sponsors
Chinese PLA General Hospital
CLINICAL TRIAL: NCT01818830
BioSeek: nct01818830
Keywords
Abstract
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.
Dates
| Last Verified: | 02/28/2013 |
| First Submitted: | 03/22/2013 |
| Estimated Enrollment Submitted: | 03/22/2013 |
| First Posted: | 03/26/2013 |
| Last Update Submitted: | 03/22/2013 |
| Last Update Posted: | 03/26/2013 |
| Actual Study Start Date: | 02/29/2012 |
| Estimated Primary Completion Date: | 04/30/2013 |
Condition or disease
Sepsis
Amino Acids
Phase
-
Arm Groups
| 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. |
Eligibility Criteria
| Ages Eligible for Study | 18 Years To 18 Years |
| Sexes Eligible for Study | All |
| Sampling method | Probability Sample |
| Accepts Healthy Volunteers | Yes |
| 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. |
Outcome
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.
