- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01818830
Amino Acids Expression Profiling of Patients With Sepsis
March 23, 2013 updated by: Longxiang Su, Chinese PLA General Hospital
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.
Study Overview
Status
Unknown
Conditions
Study Type
Observational
Enrollment (Anticipated)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100853
- Chinese PLA General Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
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.
Description
Inclusion Criteria:
- Male and female aged 18 years old and over;
- Clinically confirmed infection;
- 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:
- parenteral nutrition;
- diabetes and other metabolic-related diseases;
- chronic liver disease;
- neutropenia (≤ 500 neutrophils/mm3);
- HIV infection;
- patients or their relatives refused.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
28 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Lixin Xie, doctor, Department of Respiratory Diseases, Chinese PLA General Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2012
Primary Completion (Anticipated)
May 1, 2013
Study Registration Dates
First Submitted
March 23, 2013
First Submitted That Met QC Criteria
March 23, 2013
First Posted (Estimate)
March 27, 2013
Study Record Updates
Last Update Posted (Estimate)
March 27, 2013
Last Update Submitted That Met QC Criteria
March 23, 2013
Last Verified
March 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PLAGHHN2013001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Sepsis
-
University of Kansas Medical CenterUniversity of KansasRecruitingSepsis | Septic Shock | Sepsis Syndrome | Sepsis, Severe | Sepsis Bacterial | Sepsis BacteremiaUnited States
-
Jip GroenInBiomeRecruitingMicrobial Colonization | Neonatal Infection | Neonatal Sepsis, Early-Onset | Microbial Disease | Clinical Sepsis | Culture Negative Neonatal Sepsis | Neonatal Sepsis, Late-Onset | Culture Positive Neonatal SepsisNetherlands
-
The University of QueenslandRoyal Brisbane and Women's HospitalUnknown
-
Karolinska InstitutetÖrebro University, SwedenCompletedSepsis | Sepsis Syndrome | Sepsis, SevereSweden
-
Ohio State UniversityCompletedSepsis, Severe Sepsis and Septic ShockUnited States
-
Indonesia UniversityCompletedSevere Sepsis With Septic Shock | Severe Sepsis Without Septic ShockIndonesia
-
University of LeicesterUniversity Hospitals, Leicester; The Royal College of AnaesthetistsCompletedSepsis | Septic Shock | Severe Sepsis | Sepsis SyndromeUnited Kingdom
-
Beckman Coulter, Inc.Biomedical Advanced Research and Development AuthorityRecruitingSevere Sepsis | Severe Sepsis Without Septic ShockUnited States
-
Weill Medical College of Cornell UniversityNational Heart, Lung, and Blood Institute (NHLBI); New York Presbyterian Hospital and other collaboratorsCompletedSepsis | Septic Shock | Severe Sepsis | Infection | Sepsis SyndromeUnited States
-
Inverness Medical InnovationsCompletedSepsis | Systemic Inflammatory Response Syndrome | Severe Sepsis | Sepsis SyndromeUnited States