SIRSNCT01493492
Urinary Proteomics Analysis for Sepsis and Prognosis
An observational study of SIRS and Sepsis, run by Chinese PLA General Hospital at 1 site in China.
Trial summary
As a noninvasive examination, urinary proteomics is a very useful tool to identify renal disease. The purpose of the present study was to find differential proteins among patient with SIRS and sepsis(included survivors and non-survivors), and to screen potential biomarkers for the early diagnosis of sepsis and its… Read more about this study
- Who is it for?
- Ages 18 years and older
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- May 2010to Jan 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All subjects were selected from among inpatients who were hospitalized between May 2010 and Jan 2012 in the Respiratory ICU, Surgical ICU, and Emergency ICU, Chinese People's Liberation Army (CPLA) General Hospital.
Who may be able to join
- 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.
Who cannot join
- younger than 18 years of age;
- acquired immunodeficiency syndrome;
- reduced polymorphonuclear granulocyte counts (< 500 μL-1);
- died within 24h after admission into the ICU, or refused to participate in the study, or declined treatment during the period of observation.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Chinese PLA General Hospital
Beijing, Beijing Municipality, 100853
Lixin Xie, MD, xielx@263.net
About this study
Official title: Urinary Proteomics Analysis for Sepsis Identification and Its Prognosis in Sepsis Patient With iTRAQ Labeling and and LC-MS/MS
As a noninvasive examination, urinary proteomics is a very useful tool to identify renal disease. The purpose of the present study was to find differential proteins among patient with SIRS and sepsis(included survivors and non-survivors), and to screen potential biomarkers for the early diagnosis of sepsis and its prognosis. Urinary proteins were identified by iTRAQ labeling and LC-MS/MS. The bioinformatics analysis was performed with the Mascot software and the International Protein Index (IPI) and the Gene Ontology (GO) Database and KEGG pathway Database. The differentially expressed proteins were verified by Western blot by another sample collected from clinical.
- Keywords
- proteomics,urinary,sepsis,prognosis
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| SIRS | 1. temperature >38 ℃ or <36℃; 2. pulse rate>90 beats/min; 3. ventilatory rate>20 breaths/min or hyperventilation with partial pressure of arterial carbon dioxide (PaCO2)<32mmHg; 4. white blood cell count>12,000μL-1 or <4000μL-1 or >10% immature cells | |
| sepsis | Sepsis 1. sepsis: SIRS plus infection; 2. severe sepsis: sepsis associated with organ dysfunction, hypoperfusion, or hypotension; 3. septic shock: sepsis with arterial hypotension, despite adequate fluid resuscitation. | |
| non-survivors with sepsis | sepsis patients who died within 28 days |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival status
The survival time of patients more than 28days is defined as survival. The survival time of patients less than 28days is defined as death
Measured: 28days after admited in ICU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2011 (estimated)
- Study startMay 2010
- Primary completionJan 2012 (estimated)
- Study completionJan 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SIRSStudies of the same condition, open and under way.
- More trials run by Chinese PLA General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Lixin Xie, MD, Study director, Department of Respiratory Diseases, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01493492
- Sponsor's protocol ID
- 20111013-007(1)
- Other IDs
- 2009BAI86B03
- Status last verified
- Dec 2011
- First submitted
- 14 Dec 2011
- Last updated
- 16 Dec 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Su L, Zhou R, Liu C, Wen B, Xiao K, Kong W, Tan F, Huang Y, Cao L, Xie L. Urinary proteomics analysis for sepsis biomarkers with iTRAQ labeling and two-dimensional liquid chromatography-tandem mass spectrometry. J Trauma Acute Care Surg. 2013 Mar;74(3):940-5. doi: 10.1097/TA.0b013e31828272c5.
PubMed 23425763Su L, Cao L, Zhou R, Jiang Z, Xiao K, Kong W, Wang H, Deng J, Wen B, Tan F, Zhang Y, Xie L. Identification of novel biomarkers for sepsis prognosis via urinary proteomic analysis using iTRAQ labeling and 2D-LC-MS/MS. PLoS One. 2013;8(1):e54237. doi: 10.1371/journal.pone.0054237. Epub 2013 Jan 23.
PubMed 23372690
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Urinary Proteomics Analysis for Sepsis Identification and Its Prognosis in Sepsis Patient With iTRAQ Labeling and and LC-MS/MS
- ClinicalTrials.gov ID
- NCT01493492
- Acronym / sponsor ID
- 20111013-007(1)
- Keywords
- proteomics,urinary,sepsis,prognosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Jan 2012 (estimated)
- Study completion
- Jan 2012 (estimated)
- First posted
- 16 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
As a noninvasive examination, urinary proteomics is a very useful tool to identify renal disease. The purpose of the present study was to find differential proteins among patient with SIRS and sepsis(included survivors and non-survivors), and to screen potential biomarkers for the early diagnosis of sepsis and its prognosis. Urinary proteins were identified by iTRAQ labeling and LC-MS/MS. The bioinformatics analysis was performed with the Mascot software and the International Protein Index (IPI) and the Gene Ontology (GO) Database and KEGG pathway Database. The differentially expressed proteins were verified by Western blot by another sample collected from clinical.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SIRS | – | –1. temperature >38 ℃ or <36℃; 2. pulse rate>90 beats/min; 3. ventilatory rate>20 breaths/min or hyperventilation with partial pressure of arterial carbon dioxide (PaCO2)<32mmHg; 4. white blood cell count>12,000μL-1 or <4000μL-1 or >10% immature cells |
| sepsis | – | –Sepsis 1. sepsis: SIRS plus infection; 2. severe sepsis: sepsis associated with organ dysfunction, hypoperfusion, or hypotension; 3. septic shock: sepsis with arterial hypotension, despite adequate fluid resuscitation. |
| non-survivors with sepsis | – | –sepsis patients who died within 28 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All subjects were selected from among inpatients who were hospitalized between May 2010 and Jan 2012 in the Respiratory ICU, Surgical ICU, and Emergency ICU, Chinese People's Liberation Army (CPLA) General Hospital.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- younger than 18 years of age;
- acquired immunodeficiency syndrome;
- reduced polymorphonuclear granulocyte counts (< 500 μL-1);
- died within 24h after admission into the ICU, or refused to participate in the study, or declined treatment during the period of observation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Survival status
Time frame: 28days after admited in ICU
The survival time of patients more than 28days is defined as survival. The survival time of patients less than 28days is defined as death
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2011.
- Derived from this study: PubMed 23425763Su L, Zhou R, Liu C, Wen B, Xiao K, Kong W, Tan F, Huang Y, Cao L, Xie L. Urinary proteomics analysis for sepsis biomarkers with iTRAQ labeling and two-dimensional liquid chromatography-tandem mass spectrometry. J Trauma Acute Care Surg. 2013 Mar;74(3):940-5. doi: 10.1097/TA.0b013e31828272c5.
- Derived from this study: PubMed 23372690Su L, Cao L, Zhou R, Jiang Z, Xiao K, Kong W, Wang H, Deng J, Wen B, Tan F, Zhang Y, Xie L. Identification of novel biomarkers for sepsis prognosis via urinary proteomic analysis using iTRAQ labeling and 2D-LC-MS/MS. PLoS One. 2013;8(1):e54237. doi: 10.1371/journal.pone.0054237. Epub 2013 Jan 23.
Related trials for SIRS
Not yet recruitingObservational study
Serum GDF-15 and LGALS3BP as Prognostic Biomarkers in Sepsis
Sepsis, Septic Shock
RecruitingPhase 3
A Trial of Adjunctive Fludrocortisone (50mcg, 100mcg or Placebo) in Critically Ill Patients With Septic Shock Receiving Hydrocortisone, Evaluating Survival and Functional Recovery and the Influence of Transcriptomic Response
Septic Shock
RecruitingObservational study
Middle East Study of Infections in Patients With Hematological Malignancies
Hematological Malignancy, Hematopoetic Stem Cell Transplantation
Not yet recruitingObservational study
Comparative Study of the Genomic Characteristics of Uropathogenic Escherichia Coli According to the Severity of Community-Acquired Urinary Tract Infections in Guadeloupe (COLIGENURI)
Urinary Tract Infections
RecruitingPhase 3
CLARITHROMYCIN TO PREVENT SECONDARY INFECTIONS IN PATIENTS WITH SEPSIS FOLLOWING LOWER RESPIRATORY TRACT INFECTIONS: THE CLASSIFY TRIAL
Sepsis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lixin Xie, MD study director
Department of Respiratory Diseases, Chinese PLA General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of SIRS and Sepsis, run by Chinese PLA General Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Longxiang Su, MD (15620952878, slx77@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival status (time frame: 28days after admited in ICU). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01493492, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2011.