Severe SepsisEVLI in sepsisNCT00986271
Extravascular Lung Water Index in Severe Sepsis
A study testing EVLI was determinated by PiCCO plus system. in people with Severe Sepsis, run by Chang Gung Memorial Hospital.
Trial summary
To investigate whether extravascular lung water index (EVLI) is an independent predictor for multiorgan dysfunction syndrome (MODS) in patients with severe sepsis and to determine if increased EVLI may serve as an predictor for MODS and mortality in those patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severe Sepsis
- What is being tested?
- EVLI was determinated by PiCCO plus system.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Interventional
- 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
- Adult, Older adult
Who may be able to join
- All enrolled patients were recruited consecutively on the day of MICU admission and within 24 hours of the diagnosis of severe sepsis.
Who cannot join
- Pregnancy,
- Age less than 18 years old, and
- Uncontrolled malignancy.
About this study
To investigate whether extravascular lung water index (EVLI) is an independent predictor for multiorgan dysfunction syndrome (MODS) in patients with severe sepsis and to determine if increased EVLI may serve as an predictor for MODS and mortality in those patients.
- Conditions
- Severe Sepsis
- Being tested
- EVLI was determinated by PiCCO plus system.
- Keywords
- severe sepsis, intensive care units
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EVLI was determinated by PiCCO plus system.Procedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| With and without MODS developement | Other | EVLI was determinated by PiCCO plus system. Receives: Procedure: EVLI was determinated by PiCCO plus system. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Developement of MODS (multiorgan dysfunction syndrome) and mortality
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2009 (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.
- More trials run by Chang Gung Memorial 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00986271
- Sponsor's protocol ID
- 97-0374B
- Acronym
- EVLI in sepsis
- Status last verified
- Apr 2008
- First submitted
- 27 Sep 2009
- Last updated
- 29 Sep 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extravascular Lung Water Index in Severe Sepsis
- ClinicalTrials.gov ID
- NCT00986271
- Acronym / sponsor ID
- EVLI in sepsis / 97-0374B
- Conditions
- Severe Sepsis
- Keywords
- severe sepsis, intensive care units
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- First posted
- 29 Sep 2009 (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.
To investigate whether extravascular lung water index (EVLI) is an independent predictor for multiorgan dysfunction syndrome (MODS) in patients with severe sepsis and to determine if increased EVLI may serve as an predictor for MODS and mortality in those patients.
Study design
- Primary purpose
- Diagnosis
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| With and without MODS developement | Other | Procedure: EVLI was determinated by PiCCO plus system.EVLI was determinated by PiCCO plus system. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All enrolled patients were recruited consecutively on the day of MICU admission and within 24 hours of the diagnosis of severe sepsis.
Key exclusion criteria (3 listed)
- Pregnancy,
- Age less than 18 years old, and
- Uncontrolled malignancy.
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 |
|---|---|---|
| EVLI was determinated by PiCCO plus system. | Procedure or surgery | With and without MODS developement |
Primary outcome
Developement of MODS (multiorgan dysfunction syndrome) and mortality
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 29 Sep 2009.
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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?
A study testing EVLI was determinated by PiCCO plus system. in people with Severe Sepsis, run by Chang Gung Memorial Hospital.
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 3 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 29 Sep 2009. 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?
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?
Developement of MODS (multiorgan dysfunction syndrome) and mortality. 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 29 Sep 2009.