SepsisNCT01362829
Outcome Predictors in Patients With Severe Sepsis and Optimized Central Venous Oxygen Saturation
An observational study of Sepsis, run by National Taiwan University Hospital at 2 sites in Taiwan.
Trial summary
The investigators perform a prospective observation study to search for the outcome predictors (ScvO2 and lactate) in patients with severe sepsis after admission to ICU. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis
- What is being tested?
- Determined by intended physician
- How many people
- 90 participants
- Where
- 2 sitesTaiwan
- Study dates
- Aug 2009to May 2011
- 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: Adult patients who are admitted to medical intensive care units due to severe sepsis or septic shock
Who may be able to join
- Adult patients who are admitted to medical intensive care units with severe sepsis or septic shock
Who cannot join
- Patients would be excluded if they have any one of the exclusion criteria, *including pregnancy
- presence of acute cerebral vascular attack
- acute cardiogenic lung edema
- status asthmatics
- cardiac dysrhythmia as the primary diagnosis
- massive gastrointestinal bleeding
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- epileptics
- drug overdose
- requirement of immediate surgery
- hematologic malignancies
- febrile neutropenia
- treatment with immunosuppressive agents before admission
- advanced malignancy and poor pre-admission performance status
- with inevitable short-term mortality or morbidity
- HIV infection
- refusal of consent
Trial locations and contacts
2 sites in 1 country.
Taiwan2 sites
Far Eastern Memorial Hospital
Taipei, 100
National Taiwan University Hospital
Taipei, 100
About this study
The investigators perform a prospective observation study to search for the outcome predictors (ScvO2 and lactate) in patients with severe sepsis after admission to ICU.
Read the detailed description
Early goal-directed therapy in patients with severe sepsis or septic shock was found to provide survival benefit.It was thought that early optimization of ScvO2 within 6 hours in emergency department brought survival benefit to patients of septic shock or severe sepsis.On the other hand, early lactate clearance is associated with improved outcome in patients with severe sepsis or septic shock. In patients with severe sepsis and septic shock, those with low lactate clearance had poor prognosis, despite optimization of ScvO2. It is unknown if ScvO2 could still guide hemodynamic resuscitation after admission into ICU. The investigators perform a prospective observation study to see the correlation between ScvO2 and clinical outcome (including organ failure, disease severity, and survival) and the correlation between lactate and clinical outcome. Furthermore, if ScvO2 >= 70% is still of prognostic significance in ICU, we will investigate the outcome in patients with high ScvO2 and high serum lactate levels, and to evaluate the clinical features of this patient population.
- Conditions
- Sepsis
- Being tested
- Determined by intended physician
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Determined by intended physicianOther
We perform a prospective observational study. All the treatment for the patients are determined by intended physicians.
| Study group | Role | What they receive |
|---|---|---|
| Patients with severe sepsis | Patients who are admitted to medical ICU with severe sepsis Receives: Other: Determined by intended physician |
What is being measured
The primary outcome is the main question the study is designed to answer.
28-day Mortality
Record 28-day all-cause mortality in each population (low ScvO2, high ScvO2 and low serum lactate, high ScvO2 and high serum lactate)
Measured: 28 days
Secondary outcomes (2)
In-Hospital Mortality
Participants will be followed for the duration of hospital stay, an expected average of 2 months
Measured: 2 months
Severity of organ failure
To evaluate the development of ARDS/ALI, AKI, and the record the SOFA score
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2011 (estimated)
- Study startAug 2009
- Primary completionMay 2011
- Study completionMay 2011
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
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Far Eastern Memorial Hospital
- Investigators
- Chong-Jen Yu, MD, PhD, Principal investigator, National Taiwan University HospitalHou-Tai Chang, MD, Principal investigator, Far Eastern Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01362829
- Sponsor's protocol ID
- 200907064R
- Other IDs
- 098014-3
- Status last verified
- May 2011
- First submitted
- 24 May 2011
- Last updated
- 21 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome Predictors in Patients With Severe Sepsis and Optimized Central Venous Oxygen Saturation
- ClinicalTrials.gov ID
- NCT01362829
- Acronym / sponsor ID
- 200907064R
- Conditions
- Sepsis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- Far Eastern Memorial Hospital
- Study start
- Aug 2009
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 30 May 2011 (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 investigators perform a prospective observation study to search for the outcome predictors (ScvO2 and lactate) in patients with severe sepsis after admission to ICU.
Detailed description
Early goal-directed therapy in patients with severe sepsis or septic shock was found to provide survival benefit.It was thought that early optimization of ScvO2 within 6 hours in emergency department brought survival benefit to patients of septic shock or severe sepsis.On the other hand, early lactate clearance is associated with improved outcome in patients with severe sepsis or septic shock. In patients with severe sepsis and septic shock, those with low lactate clearance had poor prognosis, despite optimization of ScvO2. It is unknown if ScvO2 could still guide hemodynamic resuscitation after admission into ICU. The investigators perform a prospective observation study to see the correlation between ScvO2 and clinical outcome (including organ failure, disease severity, and survival) and the correlation between lactate and clinical outcome. Furthermore, if ScvO2 >= 70% is still of prognostic significance in ICU, we will investigate the outcome in patients with high ScvO2 and high serum lactate levels, and to evaluate the clinical features of this patient population.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with severe sepsis | – | Other: Determined by intended physicianPatients who are admitted to medical ICU with severe sepsis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients who are admitted to medical intensive care units due to severe sepsis or septic shock
Key inclusion criteria (1 listed)
- Adult patients who are admitted to medical intensive care units with severe sepsis or septic shock
Key exclusion criteria (16 listed)
- Patients would be excluded if they have any one of the exclusion criteria, *including pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Determined by intended physicianWe perform a prospective observational study. All the treatment for the patients are determined by intended physicians. | Other | Patients with severe sepsis |
Primary outcome
28-day Mortality
Time frame: 28 days
Record 28-day all-cause mortality in each population (low ScvO2, high ScvO2 and low serum lactate, high ScvO2 and high serum lactate)
2 secondary outcomes
In-Hospital Mortality
Time frame: 2 months
Severity of organ failure
Time frame: 1 week
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 21 Jun 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.
Chong-Jen Yu, MD, PhD principal investigator
National Taiwan University Hospital
Hou-Tai Chang, MD principal investigator
Far Eastern Memorial Hospital
2 sites 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 2 sites 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 16 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 21 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
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 21 Jun 2011.