Long-term OutcomeECMONCT03345758
Long Term Outcome of Extracorporeal Membrane Oxygenation Patients in China
An observational study of Long-term Outcome and Extracorporeal Membrane Oxygenation, run by Southeast University, China at 1 site in China.
Trial summary
Outcomes and Long-term Quality-of-life of Patients requiring Extracorporeal Membrane Oxygenation are not known in china. A prospective study survey will be performed to assess the long-term outcome of these patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Long-term Outcome, Extracorporeal Membrane Oxygenation
- What is being tested?
- outcome
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2017to 30 Dec 2023
- 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 treated with extracorporeal membrane oxygenation during March,1,2017 to March,1,2019
Who may be able to join
- require extracorporeal membrane oxygenation
Who cannot join
- irreversible disease
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Nanjing Zhong-Da Hospital
Nanjing, Jiangsu, 210009
Ling Liu, MD., 86-25-83272201, liuling6600@yahoo.com
Haibo Qiu, PhD.,MD., 86-25-83272200, haiboq2200@yahoo.com
About this study
Official title: Department of Critical Care Medicine, Nanjing Zhong-Da Hospital, Southeast University School of Medicine,China;
Outcomes and Long-term Quality-of-life of Patients requiring Extracorporeal Membrane Oxygenation are not known in china. A prospective study survey will be performed to assess the long-term outcome of these patients.
Read the detailed description
Patients admitted to ICUs and treated with extracorporeal membrane oxygenation from March 1,2015 to March 1,2019 were screened . Pre-Ecmo clinical parameters(diagnose,APACHE-II, SOFA,indications,expected mortality) and related treatment conditions(duration of ICU stay, duration of ECMO,duration of mechanical ventilation,ventilation conditions,prone ventilation,ECMO complications )will be used to assess the severity and curative effect of these patients.Short Form-36 Health Status Questionnaire,EuroQol-5 Dimensions and St. George's Respiratory Questionnaire(SGRQ) will deliver in these survivors ,which are used to assess the physical and mental health ,as well as the social adaptation. Finally a comprehensive assessment will be obtained to describe the outcomes and long-term quality-of-life of patients treated With ECMO.
- Being tested
- outcome
- Keywords
- respiratory failure, circulatory failure
- Medical subject headings
- Respiratory Insufficiency, Shock
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
outcomeOther
telephone to patients to finish SF-36 (the MOS item short from health survey,SF-36)，EQ-5D(EuroQol-5 Dimensions,EQ-5D)， AMT-4（Abbreviated Mental Test-4,AMT-4）and MMSE（Mini-mental State Examination,MMSE） to make assessments of their physical and mental health, cognitive function and social adaptation after discharge
| Study group | Role | What they receive |
|---|---|---|
| ECMO mode,outcome | ECMO mode includes VV-ECMO and VA-ECMO, outcome includes survive condition , physical and mental health, cognitive function and social adaptation Receives: Other: outcome |
What is being measured
The primary outcome is the main question the study is designed to answer.
survival rate
survival rate at discharge
Measured: August,1,2017-March,1,2020
Secondary outcomes (2)
Quality of live
Questionnaire：mobility，personal care (washing/dressing)，usual activities，Pain/discomfort，Anxiety/depression
Measured: August,1,2017-March,1,2020
Cognitive function
MMSE Questionnaire
Measured: August,1,2017-March,1,2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2017
- Study start1 Aug 2017
- Primary completion30 Dec 2023 (estimated)
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Long-term OutcomeStudies 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 only
- Time perspective
- Prospective
- Enrolment
- 80 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
- Investigators
- Haibo Qiu, MD, Study director, professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03345758
- Sponsor's protocol ID
- 20170717
- Acronym
- ECMO
- Status last verified
- Jul 2022
- First submitted
- 15 Oct 2017
- Last updated
- 19 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Department of Critical Care Medicine, Nanjing Zhong-Da Hospital, Southeast University School of Medicine,China;
- ClinicalTrials.gov ID
- NCT03345758
- Acronym / sponsor ID
- ECMO / 20170717
- Keywords
- respiratory failure, circulatory failure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Southeast University, ChinaUniversity, hospital or other
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 30 Dec 2023 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 17 Nov 2017 (actual)
- 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.
Outcomes and Long-term Quality-of-life of Patients requiring Extracorporeal Membrane Oxygenation are not known in china. A prospective study survey will be performed to assess the long-term outcome of these patients.
Detailed description
Patients admitted to ICUs and treated with extracorporeal membrane oxygenation from March 1,2015 to March 1,2019 were screened . Pre-Ecmo clinical parameters(diagnose,APACHE-II, SOFA,indications,expected mortality) and related treatment conditions(duration of ICU stay, duration of ECMO,duration of mechanical ventilation,ventilation conditions,prone ventilation,ECMO complications )will be used to assess the severity and curative effect of these patients.Short Form-36 Health Status Questionnaire,EuroQol-5 Dimensions and St. George's Respiratory Questionnaire(SGRQ) will deliver in these survivors ,which are used to assess the physical and mental health ,as well as the social adaptation. Finally a comprehensive assessment will be obtained to describe the outcomes and long-term quality-of-life of patients treated With ECMO.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ECMO mode,outcome | – | Other: outcomeECMO mode includes VV-ECMO and VA-ECMO, outcome includes survive condition , physical and mental health, cognitive function and social adaptation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients treated with extracorporeal membrane oxygenation during March,1,2017 to March,1,2019
Key inclusion criteria (1 listed)
- require extracorporeal membrane oxygenation
Key exclusion criteria (1 listed)
- irreversible disease
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 |
|---|---|---|
| outcometelephone to patients to finish SF-36 (the MOS item short from health survey,SF-36)，EQ-5D(EuroQol-5 Dimensions,EQ-5D)， AMT-4（Abbreviated Mental Test-4,AMT-4）and MMSE（Mini-mental State Examination,MMSE） to make assessments of their physical and mental health, cognitive function and social adaptation after discharge | Other | ECMO mode,outcome |
Primary outcome
survival rate
Time frame: August,1,2017-March,1,2020
survival rate at discharge
2 secondary outcomes
Quality of live
Time frame: August,1,2017-March,1,2020
Cognitive function
Time frame: August,1,2017-March,1,2020
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2022.
- Individual participant dataSharing planned: No
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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.
Haibo Qiu, MD study director
professor
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 Long-term Outcome and Extracorporeal Membrane Oxygenation, run by Southeast University, China at 1 site in 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 19 Jul 2022. 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 China. 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 ling liu, MD (13851435472, liulingdoctor@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
survival rate (time frame: August,1,2017-March,1,2020). 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 19 Jul 2022.