Severe SepsisNCT01919138
Outcomes of Severe Sepsis Patients in Surgical Intensive Care Units
An observational study of Severe Sepsis and Septic Shock, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Retrospective review of the outcomes of severe sepsis patients in Surgical Intensive Care Unit of National Taiwan University Hospital from January 1, 2009 to December 31, 2011. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Severe Sepsis, Septic Shock
- How many people
- 762 participants
- Where
- 1 siteTaiwan
- Study dates
- Jul 2013to Jun 2014
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Paitent with Severe Spesis in Surgical Intensive Care Units of National Taiwan University Hospital
Who may be able to join
- Patients were diagnosed as severe sepsis in Surgical Intensive Care units of National Taiwan University Hospital
Who cannot join
- < 20 years old
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Outcomes of Severe Sepsis Patients in Surgical Intensive Care Units of National Taiwan University Hospital: Retrospective Review
Retrospective review of the outcomes of severe sepsis patients in Surgical Intensive Care Unit of National Taiwan University Hospital from January 1, 2009 to December 31, 2011.
Read the detailed description
Patients suffered from severe sepsis or septic shock have a mortality of 20~54%. It is major healthcare problems, affecting millions of individuals around the world each year. An international group of experts in the diagnosis and management of infection and sepsis, representing 11 organizations, published the first internationally accepted guidelines that the bedside clinician could use to improve outcomes in severe sepsis and septic shock in 2004, and further outcome was reported in 2008. Lots of medical centers have joined the Surviving Sepsis Campaign and follow the latest guideline. Many reports have shown that Surviving Sepsis Campaign Guideline can reduce patient mortality.
In surgical intensive care units of National Taiwan University Hospital (NTUH), the Surviving Sepsis Campaign Guideline was conducted since 2009. Our purpose is to investigate the characteristics and outcomes of severe sepsis patient in surgical intensive care units of NTUH by retrospective review of medical chart.
- Conditions
- Severe Sepsis, Septic Shock
- Medical subject headings
- Sepsis, Shock, Septic
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 |
|---|---|---|
| severe sepsis, septic shock | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
survival rate of severe sepsis patients in Surgical Intensive Care Units
Measured: up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2013 (estimated)
- Study startJul 2013
- Primary completionDec 2013
- Study completionJun 2014
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.
- 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 762 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yu-Chang Yeh, MD, PhD, Principal investigator, Department of Anesthesiology, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01919138
- Sponsor's protocol ID
- 201305085RINC
- Status last verified
- Jun 2014
- First submitted
- 7 Aug 2013
- Last updated
- 24 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Severe Sepsis Patients in Surgical Intensive Care Units of National Taiwan University Hospital: Retrospective Review
- ClinicalTrials.gov ID
- NCT01919138
- Acronym / sponsor ID
- 201305085RINC
- Conditions
- Severe Sepsis, Septic Shock
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 762 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 8 Aug 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.
Retrospective review of the outcomes of severe sepsis patients in Surgical Intensive Care Unit of National Taiwan University Hospital from January 1, 2009 to December 31, 2011.
Detailed description
Patients suffered from severe sepsis or septic shock have a mortality of 20~54%. It is major healthcare problems, affecting millions of individuals around the world each year. An international group of experts in the diagnosis and management of infection and sepsis, representing 11 organizations, published the first internationally accepted guidelines that the bedside clinician could use to improve outcomes in severe sepsis and septic shock in 2004, and further outcome was reported in 2008. Lots of medical centers have joined the Surviving Sepsis Campaign and follow the latest guideline. Many reports have shown that Surviving Sepsis Campaign Guideline can reduce patient mortality.
In surgical intensive care units of National Taiwan University Hospital (NTUH), the Surviving Sepsis Campaign Guideline was conducted since 2009. Our purpose is to investigate the characteristics and outcomes of severe sepsis patient in surgical intensive care units of NTUH by retrospective review of medical chart.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| severe sepsis, septic shock | – | – |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Paitent with Severe Spesis in Surgical Intensive Care Units of National Taiwan University Hospital
Key inclusion criteria (1 listed)
- Patients were diagnosed as severe sepsis in Surgical Intensive Care units of National Taiwan University Hospital
Key exclusion criteria (1 listed)
- < 20 years old
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
survival rate of severe sepsis patients in Surgical Intensive Care Units
Time frame: up to 1 year
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 24 Jun 2014.
Related trials for Severe Sepsis
RecruitingObservational study
Early Detection and Kinetics of Sepsis-Induced Coagulopathy in Severe Burn Patients
Sepsis, Sepsis-induced Coagulopathy
RecruitingObservational study
Early Detection and Kinetics of Sepsis-Induced Coagulopathy in Severe Burn Patients
Peer Bullying Intervention, Vodcast
Not yet recruitingObservational study
Blood Pressure Goal in Preterm Preeclampsia
Hypertensive Disorder of Pregnancy, Preeclampsia
Not yet recruitingEarly Phase 1
25BT056: Basket Study of Viral Cytotoxic T Lymphocytes
EBV Viremia, CMV Viremia
Recruiting
Efficacy and Safety of Methylene Blue in the Treatment of Severe Septic Shock
Septic Shock, Methylene Blue
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.
Yu-Chang Yeh, MD, PhD principal investigator
Department of Anesthesiology, National Taiwan University 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 Severe Sepsis and Septic Shock, 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 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: finished, as of the sponsor's last update on 24 Jun 2014. 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?
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?
survival rate of severe sepsis patients in Surgical Intensive Care Units (time frame: up to 1 year). 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 24 Jun 2014.