Systemic Inflammatory Response SyndromeNCT01838525
Alpha-1-acid Glycoprotein as a Biomarker of Developmental Diagnosing and Monitoring Effectiveness in Sepsis
An observational study of Systemic Inflammatory Response Syndrome and Sepsis, run by Chinese PLA General Hospital at 1 site in China.
Trial summary
To assess the potential value of alpha-1-acid glycoprotein (AGP) for early diagnosis and prognosis of patients with sepsis, and then compared with C-reactive protein (CRP), procalcitonin (PCT), white blood cell (WBC) counts, Acute Physiology and Chronic Health Evaluation (APACHE) II score and Sequential Organ Failure… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Systemic Inflammatory Response Syndrome, Sepsis
- How many people
- 1 participants
- Where
- 1 siteChina
- Study dates
- Apr 2011to Jun 2013
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Between April 2011 and APRIL 2013, inpatients were included who were in the intensive care units (ICU) of the Department of Respiratory Disease (RICU), the Emergency Department (EICU), and the Department of Surgery (SICU) of the Chinese People's Liberation Army General Hospital.
Who may be able to join
- Male and female aged 18 years old and over;
- Clinically suspected 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
- less than 18 years old;
- immunosuppression;
- agranulocytosis (granulocyte counts <0.5× 109/L);
- chronic myeloid leukemia (CML);
- malignancy;
- less than 24 hours of the length of ICU stay;
- reluctant to participate in the study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Chinese PLA General Hospital
Beijing, Beijing Municipality, 100853
Lixin Xie, doctor, +86 010 55499130, xielx@263.net
About this study
To assess the potential value of alpha-1-acid glycoprotein (AGP) for early diagnosis and prognosis of patients with sepsis, and then compared with C-reactive protein (CRP), procalcitonin (PCT), white blood cell (WBC) counts, Acute Physiology and Chronic Health Evaluation (APACHE) II score and Sequential Organ Failure Assessment (SOFA) score. 164 patients were enrolled in the study, including 25 cases with systemic inflammatory response syndrome (SIRS) and 139 cases with different levels of sepsis (46 moderate sepsis, 52 severe sepsis and 41 septic shock ). Serum levels of Alpha-1-acid Glycoprotein (AGP), C-reactive protein (CRP), and procalcitonin (PCT), and white blood cell (WBC) counts were measured on the day of admission to intensive care unit (ICU).
- Conditions
- Systemic Inflammatory Response Syndrome, Sepsis
- Keywords
- sepsis, alpha-1-acid glycoprotein (AGP), diagnosis, prognosis, SIRS
- Medical subject headings
- Systemic Inflammatory Response Syndrome, Sepsis, Disease
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, SEPSIS | Not described | |
| sepsis, severe sepsis, septic shock | Not described | |
| health, SIRS, Sepsis | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients Outcome
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
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2013 (estimated)
- Study startApr 2011
- Primary completionJun 2013 (estimated)
- Study completionJun 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Systemic Inflammatory Response SyndromeStudies 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
- 1 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Longxiang Su, Chinese PLA General Hospital
- Investigators
- Lixin Xie, doctor, Study director, Department Of Respiratory Diseases, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01838525
- Sponsor's protocol ID
- 20130419-007
- Status last verified
- Apr 2013
- First submitted
- 19 Apr 2013
- Last updated
- 24 Apr 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Xiao K, Su L, Yan P, Han B, Li J, Wang H, Jia Y, Li X, Xie L. alpha-1-Acid glycoprotein as a biomarker for the early diagnosis and monitoring the prognosis of sepsis. J Crit Care. 2015 Aug;30(4):744-51. doi: 10.1016/j.jcrc.2015.04.007. Epub 2015 Apr 17.
PubMed 25957497
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alpha-1-acid Glycoprotein as a Biomarker of Developmental Diagnosing and Monitoring Effectiveness in Sepsis
- ClinicalTrials.gov ID
- NCT01838525
- Acronym / sponsor ID
- 20130419-007
- Conditions
- Systemic Inflammatory Response Syndrome, Sepsis
- Keywords
- sepsis, alpha-1-acid glycoprotein (AGP), diagnosis, prognosis, SIRS
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Jun 2013 (estimated)
- Study completion
- Jun 2013 (estimated)
- First posted
- 24 Apr 2013 (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.
To assess the potential value of alpha-1-acid glycoprotein (AGP) for early diagnosis and prognosis of patients with sepsis, and then compared with C-reactive protein (CRP), procalcitonin (PCT), white blood cell (WBC) counts, Acute Physiology and Chronic Health Evaluation (APACHE) II score and Sequential Organ Failure Assessment (SOFA) score. 164 patients were enrolled in the study, including 25 cases with systemic inflammatory response syndrome (SIRS) and 139 cases with different levels of sepsis (46 moderate sepsis, 52 severe sepsis and 41 septic shock ). Serum levels of Alpha-1-acid Glycoprotein (AGP), C-reactive protein (CRP), and procalcitonin (PCT), and white blood cell (WBC) counts were measured on the day of admission to intensive care unit (ICU).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SIRS, SEPSIS | – | – |
| sepsis, severe sepsis, septic shock | – | – |
| health, SIRS, Sepsis | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Between April 2011 and APRIL 2013, inpatients were included who were in the intensive care units (ICU) of the Department of Respiratory Disease (RICU), the Emergency Department (EICU), and the Department of Surgery (SICU) of the Chinese People's Liberation Army General Hospital.
Key inclusion criteria (3 listed)
- Male and female aged 18 years old and over;
- Clinically suspected 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;
Key exclusion criteria (7 listed)
- less than 18 years old;
- immunosuppression;
- agranulocytosis (granulocyte counts <0.5× 109/L);
- chronic myeloid leukemia (CML);
- malignancy;
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2013.
- Derived from this study: PubMed 25957497Xiao K, Su L, Yan P, Han B, Li J, Wang H, Jia Y, Li X, Xie L. alpha-1-Acid glycoprotein as a biomarker for the early diagnosis and monitoring the prognosis of sepsis. J Crit Care. 2015 Aug;30(4):744-51. doi: 10.1016/j.jcrc.2015.04.007. Epub 2015 Apr 17.
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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, doctor 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 Systemic Inflammatory Response Syndrome 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 3 inclusion and 7 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 24 Apr 2013. 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 Kun Xiao, graduate (+86 13716608331, xiaok301@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patients Outcome (time frame: 28 days). 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 NCT01838525, which also lists 1 linked publication.
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 24 Apr 2013.