Septic ShockNCT01685112
Comparison of ECMO Use and Conventional Treatment in Adults With Septic Shock
An observational study of Septic Shock, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Although few cases reported successful treatment of septic shock using extracorporeal membrane oxygenation (ECMO) in adults, no studies compared ECMO to conventional treatment (without ECMO) as treatment for adults with septic shock. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Septic Shock
- How many people
- 300 participants
- Where
- 1 siteTaiwan
- Study dates
- Sep 2012to Aug 2013
- 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: Adults patient who admitted to ICU and had severe sepsis and progressed to septic shock
Who may be able to join
- age >20
- admitted at ICU
- septic shock
Who cannot join
- nil
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, Taiwan, 100
YuChung Chuang, MD, 886-972652532, weischuang@gmail.com
YuChung Chuang, MD
About this study
Although few cases reported successful treatment of septic shock using extracorporeal membrane oxygenation (ECMO) in adults, no studies compared ECMO to conventional treatment (without ECMO) as treatment for adults with septic shock. Since it is difficult to conduct a randomized study to allocate patients in such critical condition, we aimed to conduct a retrospective observational study using propensity score matched analysis to compare the survival of adults with septic shock treated by ECMO or conventional treatment.
- Conditions
- Septic Shock
- Keywords
- adults, ECMO
- Medical subject headings
- 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 |
|---|---|---|
| Conventional Group | Patients who developed refractory shock, but didn't received ECMO as salvage treatment | |
| ECMO group | Patient who have septic shock, and progreseed to have ECMO as salvage therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
In hospital mortality
inhospital mortality as primary outcome, mean length of hospital stay around 30 days
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2012 (estimated)
- Study startSep 2012
- Primary completionAug 2013 (estimated)
- Study completionAug 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Septic ShockStudies 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
- Retrospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- YuChung Chuang, MD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01685112
- Sponsor's protocol ID
- 201207079RIC
- Status last verified
- Sep 2012
- First submitted
- 11 Sep 2012
- Last updated
- 12 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of ECMO Use and Conventional Treatment in Adults With Septic Shock
- ClinicalTrials.gov ID
- NCT01685112
- Acronym / sponsor ID
- 201207079RIC
- Conditions
- Septic Shock
- Keywords
- adults, ECMO
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Aug 2013 (estimated)
- Study completion
- Aug 2013 (estimated)
- First posted
- 13 Sep 2012 (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.
Although few cases reported successful treatment of septic shock using extracorporeal membrane oxygenation (ECMO) in adults, no studies compared ECMO to conventional treatment (without ECMO) as treatment for adults with septic shock. Since it is difficult to conduct a randomized study to allocate patients in such critical condition, we aimed to conduct a retrospective observational study using propensity score matched analysis to compare the survival of adults with septic shock treated by ECMO or conventional treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional Group | – | –Patients who developed refractory shock, but didn't received ECMO as salvage treatment |
| ECMO group | – | –Patient who have septic shock, and progreseed to have ECMO as salvage therapy |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults patient who admitted to ICU and had severe sepsis and progressed to septic shock
Key inclusion criteria (3 listed)
- age >20
- admitted at ICU
- septic shock
Key exclusion criteria (1 listed)
- nil
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
In hospital mortality
Time frame: 30 days
inhospital mortality as primary outcome, mean length of hospital stay around 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2012.
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ICU-SUCCEED for Survivors of Acute Respiratory Failure and Their Caregivers
Acute Respiratory Failure, Critical Illness
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Longitudinal Trajectories of Myocardial Work in Patients With Sepsis
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Sepsis
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.
YuChung Chuang, MD principal investigator
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 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 3 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 12 Oct 2012. 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 YuChung Chuang, MD (886-972652532, weischuang@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
In hospital mortality (time frame: 30 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 12 Oct 2012.