Severe SepsisNCT01211899
4G/5G Polymorphism of Plasminogen Activator Inhibitor-1 Gene and Disseminated Intravascular Coagulation in Severe Sepsis and Septic Shock
An observational study of Severe Sepsis, run by Hallym University Medical Center.
Trial summary
Data on 4G/5G polymorphism of plasminogen activator inhibitor-1 (PAI-1) gene are limited in Asian patients with sepsis. Therefore, the investigators aim to prospectively investigate the incidence of 4G/5G polymorphism and its relationship with disseminated intravascluar coagulatin in patients with severe sepsis and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severe Sepsis
- How many people
- 160 participants
- Where
- No sites listed yet
- Study dates
- Sep 2010to Sep 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: Patients admitted to the ICU for severe sepsis or septic shock
Who may be able to join
- Adult patinents aged > 18 years, Patients satisfying the criteria by 2008 Surviving Sepsis Campagin, Patients who are determined as having a sepsis within 24 hours of ICU stay
Who cannot join
- Do-not-resuscitate, cardiopulmonary resuscitation, ICU stay < 1 day, Refusal to participate in the study, Hematologic malignancy or liver cirrhosis (Child C), Congenital abnormality in coagulation system, Transfer from other ICUs or hospitals
About this study
Official title: Incidence and Prognosis of Disseminated Intravscular Coagulation in Patients Severe Sepsis and Septic Shock; Association With 4G/5G Polymorphism of PAI-1 Gene
Data on 4G/5G polymorphism of plasminogen activator inhibitor-1 (PAI-1) gene are limited in Asian patients with sepsis. Therefore, the investigators aim to prospectively investigate the incidence of 4G/5G polymorphism and its relationship with disseminated intravascluar coagulatin in patients with severe sepsis and septic shock.
- Conditions
- Severe Sepsis
- Keywords
- polymorphism,, plasminogen activator inhibitor,, disseminated intravascular coagulation,
- Medical subject headings
- Sepsis, Disseminated Intravascular Coagulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2010 (estimated)
- Study startSep 2010
- Primary completionSep 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe SepsisStudies 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hallym University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01211899
- Sponsor's protocol ID
- f2000tj2
- Status last verified
- Sep 2010
- First submitted
- 29 Sep 2010
- Last updated
- 5 Oct 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence and Prognosis of Disseminated Intravscular Coagulation in Patients Severe Sepsis and Septic Shock; Association With 4G/5G Polymorphism of PAI-1 Gene
- ClinicalTrials.gov ID
- NCT01211899
- Acronym / sponsor ID
- f2000tj2
- Conditions
- Severe Sepsis
- Keywords
- polymorphism,, plasminogen activator inhibitor,, disseminated intravascular coagulation,
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Hallym University Medical CenterUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Sep 2012 (estimated)
- First posted
- 30 Sep 2010 (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.
Data on 4G/5G polymorphism of plasminogen activator inhibitor-1 (PAI-1) gene are limited in Asian patients with sepsis. Therefore, the investigators aim to prospectively investigate the incidence of 4G/5G polymorphism and its relationship with disseminated intravascluar coagulatin in patients with severe sepsis and septic shock.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to the ICU for severe sepsis or septic shock
Key inclusion criteria (1 listed)
- Adult patinents aged > 18 years, Patients satisfying the criteria by 2008 Surviving Sepsis Campagin, Patients who are determined as having a sepsis within 24 hours of ICU stay
Key exclusion criteria (1 listed)
- Do-not-resuscitate, cardiopulmonary resuscitation, ICU stay < 1 day, Refusal to participate in the study, Hematologic malignancy or liver cirrhosis (Child C), Congenital abnormality in coagulation system, Transfer from other ICUs or hospitals
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 5 Oct 2011.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Severe Sepsis, run by Hallym University Medical Center.
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 1 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 5 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. 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 5 Oct 2011.