SepsisNCT00800631
The Biomarker and Cardiac Function in Sepsis
An observational study of Sepsis, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
The development and severity of sepsis induced myocardial dysfunction can be monitored from the serum biomarker. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis
- How many people
- 150 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2008to Dec 2009
- 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: sepsis
Who may be able to join
- Sepsis patients with 2 of the followings when arrival ER and treated > 6 hours:
- BT >38℃ or<36℃
- HR >90/min
- RR >20/min or PaCO2 < 32 mmHg
- WBC count >12×109/L or <4×109/L or immature form >10％
Who cannot join
- Age < 18
- Major trauma patients
- Pregnancy
- Willing to do not aggressive treatment
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
ER of National Taiwan Univeristy Hospital
Taipei, 100
Chiung Yuan Hsu, Mph, 886-2-23123456 ext. 65926, dtemer01@gmail.com
About this study
Official title: The Biomarker and Associated Cardiac Function in the Patients With Sepsis
The development and severity of sepsis induced myocardial dysfunction can be monitored from the serum biomarker.
- Conditions
- Sepsis
- Medical subject headings
- Sepsis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2008 (estimated)
- Study startJan 2008
- Primary completionJan 2009 (estimated)
- Study completionDec 2009 (estimated)
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 National Taiwan University 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00800631
- Sponsor's protocol ID
- 200708002R
- Status last verified
- Dec 2008
- First submitted
- 1 Dec 2008
- Last updated
- 2 Dec 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Biomarker and Associated Cardiac Function in the Patients With Sepsis
- ClinicalTrials.gov ID
- NCT00800631
- Acronym / sponsor ID
- 200708002R
- Conditions
- Sepsis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Jan 2009 (estimated)
- Study completion
- Dec 2009 (estimated)
- First posted
- 2 Dec 2008 (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.
The development and severity of sepsis induced myocardial dysfunction can be monitored from the serum biomarker.
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
- sepsis
Key inclusion criteria (5 listed)
- Sepsis patients with 2 of the followings when arrival ER and treated > 6 hours:
Key exclusion criteria (4 listed)
- Age < 18
- Major trauma patients
- Pregnancy
- Willing to do not aggressive treatment
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 2 Dec 2008.
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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 Sepsis, run by National Taiwan University Hospital at 1 site in Taiwan.
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 5 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 2 Dec 2008. 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 Taiwan. 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 ChiungYuan Hsu, Mph (886-2-23123456 ext. 65926, dtemer01@gmail.com), 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 2 Dec 2008.