Clinical trial NCT01818830: Amino Acids Expression Profiling of Patients With Sepsis
Official title: Amino Acids Expression Profiling of Patients With Sepsis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sepsis
Amino Acids
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2013-03-27
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
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.

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.


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.

Primary outcomes:
measure: Patients Outcome
timeFrame: 28 days
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese PLA General Hospital
state: Beijing
Study officials:
affiliation: Department of Respiratory Diseases, Chinese PLA General Hospital
name: Lixin Xie, Doctor
role: STUDY_DIRECTOR
References:
citation: 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.