ECMO TreatmentNCT01677117
Clinical Studies of the Effects of Extracorporeal Membrane Oxygenation for Severe ARDS Mortality
An observational study of ECMO Treatment, run by Southeast University, China.
Trial summary
Acute respiratory distress syndrome (acute respiratory distress syndrome, ARDS) fatality rate can be as high as 20% -41%, once progress is severe of ARDS, mortality rose to 90%, the main cause of death was refractory hypoxemia. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- ECMO Treatment
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- Aug 2012to Dec 2012
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: severe ARDS patients
Who may be able to join
- age 18-70 years; (2) severe respiratory dysfunction (Murry score ≥ 3 points or clinical optimized ventilation conditions pH remains <7.2 patients); (3) PaCO2/FiO2 <100mmHg; (4) plateau pressure >30cmH2O more than 6h，duration of no more than seven days; (5) with severe respiratory dysfunction etiology reversible.
Who cannot join
- high levels pressure mechanical ventilation (PEEP> 15-20cmH2O and / or Pplat> 35-40cmH2O) over 7 days; (2) continued to receive high concentrations of oxygen (FiO2> 80%) is more than 7 days; (3) severe active bleeding; (4) within 24 hours of the surgery or head injury with intracranial bleeding; (5) a variety of serious irreversible state; (6) malignancy; (7) progressive pulmonary fibrosis; (8) can not surgical problems; (9) due to cardiac dysfunction leading to ARDS.
About this study
Acute respiratory distress syndrome (acute respiratory distress syndrome, ARDS) fatality rate can be as high as 20% -41%, once progress is severe of ARDS, mortality rose to 90%, the main cause of death was refractory hypoxemia. Mechanical ventilation as the main measure to improve hypoxemia cannot correct all hypoxemia and relating complications of mechanical ventilation, mechanical ventilation in the treatment of severe ARDS has gradually been challenged. Extracorporeal membrane oxygenation（ECMO) technology matures, so that clinicians have more choices in the face of hypoxemia, and with the deepening understanding of ECMO, ECMO may become severe ARDS first-line treatment. Currently, ECMO therapy has been recognized by the majority of medical workers. Therefore, we assume that accurately grasping the ECMO indications and standardizing the implementation of treatment can significantly improve the prognosis, shorter hospital stays, lower hospitalization costs.
- Conditions
- ECMO Treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2012 (estimated)
- Study startAug 2012
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ECMO TreatmentStudies 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 crossover
- Time perspective
- Retrospective
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Southeast University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ling Liu, Southeast University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01677117
- Sponsor's protocol ID
- ECMO treatment
- Status last verified
- Aug 2012
- First submitted
- 29 Aug 2012
- Last updated
- 31 Aug 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Studies of the Effects of Extracorporeal Membrane Oxygenation for Severe ARDS Mortality
- ClinicalTrials.gov ID
- NCT01677117
- Acronym / sponsor ID
- ECMO treatment
- Conditions
- ECMO Treatment
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Southeast University, ChinaUniversity, hospital or other
- Study start
- Aug 2012
- Study completion
- Dec 2012 (estimated)
- First posted
- 31 Aug 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.
Acute respiratory distress syndrome (acute respiratory distress syndrome, ARDS) fatality rate can be as high as 20% -41%, once progress is severe of ARDS, mortality rose to 90%, the main cause of death was refractory hypoxemia. Mechanical ventilation as the main measure to improve hypoxemia cannot correct all hypoxemia and relating complications of mechanical ventilation, mechanical ventilation in the treatment of severe ARDS has gradually been challenged. Extracorporeal membrane oxygenation（ECMO) technology matures, so that clinicians have more choices in the face of hypoxemia, and with the deepening understanding of ECMO, ECMO may become severe ARDS first-line treatment. Currently, ECMO therapy has been recognized by the majority of medical workers. Therefore, we assume that accurately grasping the ECMO indications and standardizing the implementation of treatment can significantly improve the prognosis, shorter hospital stays, lower hospitalization costs.
Study design
- Observational model
- Case crossover
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- severe ARDS patients
Key inclusion criteria (1 listed)
- age 18-70 years; (2) severe respiratory dysfunction (Murry score ≥ 3 points or clinical optimized ventilation conditions pH remains <7.2 patients); (3) PaCO2/FiO2 <100mmHg; (4) plateau pressure >30cmH2O more than 6h，duration of no more than seven days; (5) with severe respiratory dysfunction etiology reversible.
Key exclusion criteria (1 listed)
- high levels pressure mechanical ventilation (PEEP> 15-20cmH2O and / or Pplat> 35-40cmH2O) over 7 days; (2) continued to receive high concentrations of oxygen (FiO2> 80%) is more than 7 days; (3) severe active bleeding; (4) within 24 hours of the surgery or head injury with intracranial bleeding; (5) a variety of serious irreversible state; (6) malignancy; (7) progressive pulmonary fibrosis; (8) can not surgical problems; (9) due to cardiac dysfunction leading to ARDS.
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
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2012.
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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?
An observational study of ECMO Treatment, run by Southeast University, China.
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: status not confirmed, as of the sponsor's last update on 31 Aug 2012. 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?
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.
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 31 Aug 2012.