Extracorporeal Membrane Oxygenation ComplicationNCT02280460
ECMO: Optimization of Its Use
An observational study of Extracorporeal Membrane Oxygenation Complication, run by Renzo Loyaga Rendon at 1 site in United States.
Trial summary
To create a local registry for ECMO patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Extracorporeal Membrane Oxygenation Complication
- How many people
- 921 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to 29 May 2024
- How long will I take part?
- 1 Year
- 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: Patients admitted to Spectrum Health requiring ECMO therarpy. For the control, patients in the Intensive Care Unit at Spectrum Health will be considered.
Who may be able to join
- Age >18
- requiring ECMO. For the control,Patients without ECMO admited to ICU.
Who cannot join
- Age<18
- Known prisoner of the state
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Extracorporeal Membrane Oxygenation(ECMO): Optimization of Its Use
To create a local registry for ECMO patients.
Read the detailed description
To create a local registry of retrospective and prospective patients on ECMO at Spectrum Health, Butterworth campus in order to optimize the use of ECMO therapy and to create algorithms to estimate the prognosis. ECMO patients will be compared to a control group of patients. Patient mortality will be assessed in-house, at 48 hours, 3 months, and 1 year after the start of ECMO therapy.
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 |
|---|---|---|
| VA ECMO | Patients who are placed on VA ECMO. | |
| VV ECMO | Patients who are placed on VV ECMO. |
What is being measured
The primary outcome is the main question the study is designed to answer.
All cause mortality
Measured: 1 year
Secondary outcomes (2)
all cause mortality
Measured: 48 hours
In-house mortality
Measured: 30 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2014 (estimated)
- Study startSep 2014
- Primary completion29 May 2024
- Study completion29 May 2024
Why it stopped: Study was not able to achieve primary objective and there is no intention to work towards its achievement
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Extracorporeal Membrane Oxygenation ComplicationStudies of the same condition, open and under way.
- 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-control
- Time perspective
- Other
- Enrolment
- 921 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Renzo Loyaga Rendon
- Sponsor type
- University, hospital or other
- Collaborators
- Corewell Health West
- Responsible party
- Sponsor-investigator, Renzo Loyaga Rendon, Corewell Health West
- Investigators
- Renzo Loyaga-Rendon, MD,PhD, Principal investigator, Corewell Health West
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02280460
- Sponsor's protocol ID
- 2014-194
- Status last verified
- Jun 2024
- First submitted
- 29 Oct 2014
- Last updated
- 5 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zapol WM, Snider MT, Hill JD, Fallat RJ, Bartlett RH, Edmunds LH, Morris AH, Peirce EC 2nd, Thomas AN, Proctor HJ, Drinker PA, Pratt PC, Bagniewski A, Miller RG Jr. Extracorporeal membrane oxygenation in severe acute respiratory failure. A randomized prospective study. JAMA. 1979 Nov 16;242(20):2193-6. doi: 10.1001/jama.242.20.2193.
PubMed 490805Peek GJ, Mugford M, Tiruvoipati R, Wilson A, Allen E, Thalanany MM, Hibbert CL, Truesdale A, Clemens F, Cooper N, Firmin RK, Elbourne D; CESAR trial collaboration. Efficacy and economic assessment of conventional ventilatory support versus extracorporeal membrane oxygenation for severe adult respiratory failure (CESAR): a multicentre randomised controlled trial. Lancet. 2009 Oct 17;374(9698):1351-63. doi: 10.1016/S0140-6736(09)61069-2. Epub 2009 Sep 15.
PubMed 19762075
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extracorporeal Membrane Oxygenation(ECMO): Optimization of Its Use
- ClinicalTrials.gov ID
- NCT02280460
- Acronym / sponsor ID
- 2014-194
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Study was not able to achieve primary objective and there is no intention to work towards its achievement
- Enrolment
- 921 participants (actual)
- Lead sponsor
- Renzo Loyaga RendonUniversity, hospital or other
- Collaborators
- Corewell Health West
- Study start
- Sep 2014
- Primary completion
- 29 May 2024 (actual)
- Study completion
- 29 May 2024 (actual)
- First posted
- 31 Oct 2014 (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 create a local registry for ECMO patients.
Detailed description
To create a local registry of retrospective and prospective patients on ECMO at Spectrum Health, Butterworth campus in order to optimize the use of ECMO therapy and to create algorithms to estimate the prognosis. ECMO patients will be compared to a control group of patients. Patient mortality will be assessed in-house, at 48 hours, 3 months, and 1 year after the start of ECMO therapy.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VA ECMO | – | –Patients who are placed on VA ECMO. |
| VV ECMO | – | –Patients who are placed on VV ECMO. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to Spectrum Health requiring ECMO therarpy. For the control, patients in the Intensive Care Unit at Spectrum Health will be considered.
Key inclusion criteria (2 listed)
- Age >18
- requiring ECMO. For the control,Patients without ECMO admited to ICU.
Key exclusion criteria (2 listed)
- Age<18
- Known prisoner of the state
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
All cause mortality
Time frame: 1 year
2 secondary outcomes
all cause mortality
Time frame: 48 hours
In-house mortality
Time frame: 30 day
Results and safety
The study was stopped early (reason given: Study was not able to achieve primary objective and there is no intention to work towards its achievement). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2024.
- Background: PubMed 490805Zapol WM, Snider MT, Hill JD, Fallat RJ, Bartlett RH, Edmunds LH, Morris AH, Peirce EC 2nd, Thomas AN, Proctor HJ, Drinker PA, Pratt PC, Bagniewski A, Miller RG Jr. Extracorporeal membrane oxygenation in severe acute respiratory failure. A randomized prospective study. JAMA. 1979 Nov 16;242(20):2193-6. doi: 10.1001/jama.242.20.2193.
- Background: PubMed 19762075Peek GJ, Mugford M, Tiruvoipati R, Wilson A, Allen E, Thalanany MM, Hibbert CL, Truesdale A, Clemens F, Cooper N, Firmin RK, Elbourne D; CESAR trial collaboration. Efficacy and economic assessment of conventional ventilatory support versus extracorporeal membrane oxygenation for severe adult respiratory failure (CESAR): a multicentre randomised controlled trial. Lancet. 2009 Oct 17;374(9698):1351-63. doi: 10.1016/S0140-6736(09)61069-2. Epub 2009 Sep 15.
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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.
Renzo Loyaga-Rendon, MD,PhD principal investigator
Corewell Health West
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 Extracorporeal Membrane Oxygenation Complication, run by Renzo Loyaga Rendon at 1 site in United States.
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 2 inclusion and 2 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: stopped early, as of the sponsor's last update on 5 Jun 2024. 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 United States. 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 was stopped early (reason given: Study was not able to achieve primary objective and there is no intention to work towards its achievement). Results are not available in the source record.
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?
All cause mortality (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02280460, which also lists 2 linked publications.
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 5 Jun 2024.