Diagnostic and Predictive ValueNCT01687010
Diagnostic and Prognostic Value of Combination Biomarkers in the Critically Ill Patient With Sepsis.
An observational study of Diagnostic and Predictive Value, run by Jianfeng Xie at 1 site in China.
Trial summary
Sepsis is a common cause for morbidity and mortality in critically ill patients. With the development of medical skills, the mortality is still remain very high. Inappropriateness of initial antibiotic treatment is an important risk factor for mortality and effective antimicrobial administration within the first hour… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diagnostic and Predictive Value
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- Mar 2012to Oct 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: Critically ill patients
Who may be able to join
- Critically ill patients admitted into ICU
Who cannot join
- Age younger than 18 years
- Refuse to participate in this study
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Critical Care Medicine Nanjing Zhong-da Hospital Southeast University School of Medicine
Nanjing, Jiangsu, 210009
Yi Yang, M.D., Ph.D,, +8602583272202, yiyiyang2004@yahoo.com.cn
About this study
Sepsis is a common cause for morbidity and mortality in critically ill patients. With the development of medical skills, the mortality is still remain very high. Inappropriateness of initial antibiotic treatment is an important risk factor for mortality and effective antimicrobial administration within the first hour of documented hypotension was associated with increased survival to hospital discharge in adult patients with septic shock. However, the early treatment based on early diagnosis.But it is very difficult to diagnosis because of lack of specific clinic symptom and sign.When severe sepsis occur, biomarker could be helpful to diagnosis. Unfortunately, the diagnostic value of single biomarker is limited. Therefore, combine several biomarkers could enhance the diagnostic value.
- Conditions
- Diagnostic and Predictive Value
- Keywords
- CRP, PCT, IL-6, Diagnosis, Prediction
- Medical subject headings
- Disease
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2012 (estimated)
- Study startMar 2012
- Study completionOct 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diagnostic and Predictive ValueStudies of the same condition, open and under way.
- 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
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jianfeng Xie
- Sponsor type
- University, hospital or other
- Collaborators
- Southeast University, China
- Responsible party
- Sponsor-investigator, Jianfeng Xie, Southeast University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01687010
- Sponsor's protocol ID
- PCT001
- Status last verified
- Aug 2012
- First submitted
- 13 Sep 2012
- Last updated
- 18 Sep 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic and Prognostic Value of Combination Biomarkers in the Critically Ill Patient With Sepsis.
- ClinicalTrials.gov ID
- NCT01687010
- Acronym / sponsor ID
- PCT001
- Conditions
- Diagnostic and Predictive Value
- Keywords
- CRP, PCT, IL-6, Diagnosis, Prediction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Jianfeng XieUniversity, hospital or other
- Collaborators
- Southeast University, China
- Study start
- Mar 2012
- Study completion
- Oct 2012 (estimated)
- First posted
- 18 Sep 2012 (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.
Sepsis is a common cause for morbidity and mortality in critically ill patients. With the development of medical skills, the mortality is still remain very high. Inappropriateness of initial antibiotic treatment is an important risk factor for mortality and effective antimicrobial administration within the first hour of documented hypotension was associated with increased survival to hospital discharge in adult patients with septic shock. However, the early treatment based on early diagnosis.But it is very difficult to diagnosis because of lack of specific clinic symptom and sign.When severe sepsis occur, biomarker could be helpful to diagnosis. Unfortunately, the diagnostic value of single biomarker is limited. Therefore, combine several biomarkers could enhance the diagnostic value.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Critically ill patients
Key inclusion criteria (1 listed)
- Critically ill patients admitted into ICU
Key exclusion criteria (2 listed)
- Age younger than 18 years
- Refuse to participate in this study
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
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2012.
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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.
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 Diagnostic and Predictive Value, run by Jianfeng Xie 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 1 inclusion and 2 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 18 Sep 2012. 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 Jianfeng Xie, M.D. (+8602583272201, seuicu@yahoo.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 18 Sep 2012.