SepsisNCT01847248
HSPA12B as a Potential Biomarker for Sepsis and Severe Sepsis
An observational study of Sepsis, run by Changhai Hospital at 1 site in China.
Trial summary
Molecules indicating endothelial injury may serve as biomarkers for severe sepsis because of the critical role of endothelial injury in organ dysfunction during severe sepsis. HSPA12B is primarily located in endothelial cells and detectable during sepsis. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sepsis
- How many people
- 118 participants
- Where
- 1 siteChina
- Study dates
- May 2011to Oct 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: Continuous patients with sepsis, severe sepsis, SIRS after major orthopedics surgery and healthy volunteers
Who may be able to join
- Adult patients
- Patients meet the diagnostic criteria according to the grouping
Who cannot join
- patients without informed consent
- patients who were undergoing continuous renal replacement therapy before sampling
- patients with special infection induced by virus, tubercle bacillus, mycoplasma, Chlamydia, and so on
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Anesthesiology and Intensive Care Medicine, Changhai Hospital
Shanghai, 200433
About this study
- Molecules indicating endothelial injury may serve as biomarkers for severe sepsis because of the critical role of endothelial injury in organ dysfunction during severe sepsis.
- HSPA12B is primarily located in endothelial cells and detectable during sepsis.
- The investigators speculated that HSPA12B from endothelial cells might be correlated with severe sepsis.
- Conditions
- Sepsis
- Keywords
- sepsis, biomarker, HSPA12B
- 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 |
|---|---|---|
| sepsis | Patients with sepsis but not severe sepsis | |
| Severe sepsis | Patients with severe sepsis | |
| SIRS | Patients with SIRS after major orthopedics surgery | |
| Control | Healthy volunteers |
What is being measured
The primary outcome is the main question the study is designed to answer.
28-day mortality
mortality within 28 days after recruitment.
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 posted6 May 2013 (estimated)
- Study startMay 2011
- Primary completionMar 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by Changhai 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
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jia-feng Wang, Changhai Hospital
- Investigators
- Ke-ming Zhu, M.D., Principal investigator, Department of Anesthesiology and Intensive Care Medicine, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01847248
- Sponsor's protocol ID
- HSPA12B-sepsis-biomarker
- Status last verified
- Nov 2013
- First submitted
- 2 May 2013
- Last updated
- 25 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HSPA12B as a Potential Biomarker for Sepsis and Severe Sepsis
- ClinicalTrials.gov ID
- NCT01847248
- Acronym / sponsor ID
- HSPA12B-sepsis-biomarker
- Conditions
- Sepsis
- Keywords
- sepsis, biomarker, HSPA12B
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Mar 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 6 May 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.
- Molecules indicating endothelial injury may serve as biomarkers for severe sepsis because of the critical role of endothelial injury in organ dysfunction during severe sepsis.
- HSPA12B is primarily located in endothelial cells and detectable during sepsis.
- The investigators speculated that HSPA12B from endothelial cells might be correlated with severe sepsis.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| sepsis | – | –Patients with sepsis but not severe sepsis |
| Severe sepsis | – | –Patients with severe sepsis |
| SIRS | – | –Patients with SIRS after major orthopedics surgery |
| Control | – | –Healthy volunteers |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Continuous patients with sepsis, severe sepsis, SIRS after major orthopedics surgery and healthy volunteers
Key inclusion criteria (2 listed)
- Adult patients
- Patients meet the diagnostic criteria according to the grouping
Key exclusion criteria (3 listed)
- patients without informed consent
- patients who were undergoing continuous renal replacement therapy before sampling
- patients with special infection induced by virus, tubercle bacillus, mycoplasma, Chlamydia, and so on
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
28-day mortality
Time frame: 28 days
mortality within 28 days after recruitment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2013.
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Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
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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.
Ke-ming Zhu, M.D. principal investigator
Department of Anesthesiology and Intensive Care Medicine, Changhai 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 Sepsis, run by Changhai 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 2 inclusion and 3 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: finished, as of the sponsor's last update on 25 Nov 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
28-day mortality (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Nov 2013.