Amino Acids Expression Profiling of Patients With Sepsis

NCT ID: NCT01818830

Last Updated: 2013-03-27

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-03-31

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.

Conditions

Sepsis; Amino Acids

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: RETROSPECTIVE

Study Groups

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.

No interventions assigned to this group

sepsis

SIRS+infection

No interventions assigned to this group

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.

No interventions assigned to this group

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Chinese PLA General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Longxiang Su

Attending Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lixin Xie, Doctor

Role: STUDY_DIRECTOR

Department of Respiratory Diseases, Chinese PLA General Hospital

Locations

Chinese PLA General Hospital

Beijing, Beijing Municipality, China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 25849571 (View on PubMed)

Other Identifiers

PLAGHHN2013001

Identifier Type: -

Identifier Source: org_study_id