Heart FailureNCT02393274
Microcirculation in Venoarterial Extracorporeal Membrane Oxygenation Life Support
An observational study of Heart Failure and Respiratory Failure, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Extra-corporeal membrane oxygenation (ECMO) life support system can provide both cardiac and respiratory support to patients with heart and respiratory failure. It can save time for these organs to recovery or for these patients to receive further management. However, many patients will die in spite of ECMO support. Read more about this study
- Who is it for?
- Ages 20 to 79 years
- Conditions the study is for
- Heart Failure, Respiratory Failure
- What is being tested?
- Extra-corporeal membrane oxygenation life support
- Type of treatment
- Medical device
- How many people
- 48 participants
- Where
- 1 siteTaiwan
- Study dates
- Apr 2015to Dec 2016
- 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 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who require venoarterial extra-corporeal membrane oxygenation (ECMO) life support
Who may be able to join
- Patients who require venoarterial extra-corporeal membrane oxygenation (ECMO) life support
Who cannot join
- who can not take an examination of sublingual microcirculation within 6 hours after placement of venoarterial ECMO support
- Non-native speakers
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of Microcirculation in Patients With Venoarterial Extracorporeal Membrane Oxygenation Life Support
Extra-corporeal membrane oxygenation (ECMO) life support system can provide both cardiac and respiratory support to patients with heart and respiratory failure. It can save time for these organs to recovery or for these patients to receive further management. However, many patients will die in spite of ECMO support. One of the key factor is whether the blood flow provided by the ECMO can meet the requirement of organ perfusion. The adequacy of macrocirculation may be determined by arterial pressure and minute blood flow of ECMO. However, the adequacy of microcirculation remains as a major unresolved clinical problem. This is a prospective observational clinical trial. The sublingual microcirculation will be examined with the incident dark field video microscope within 6 hours after venoarterial ECMO placement, and then at 24 h, 48 h, 72 h, and 96 h. The severity of multiple organ injury and clinical data will be recorded as well. The major parameters of microcirculation include total small vessel density, perfused small vessel density, and microvascular flow index. The sublingual microcirculation will also be examined before weaning off ECMO, within 6 hours after ECMO removal, and then at 24 h, 48 h, and 72 h. Serum level of endothelial cell specific molecule-1 at specific time points will be examined. The data of 14-day mortality, 28-day mortality, duration of ECMO support, and intensive care unit stay will be recorded. This study aims primarily to investigate the relationship between microcirculation and prognosis of these patients. This study will also investigate the relationship among serum level of endothelial cell specific molecule-1, microcirculation, and prognosis of these patients. Wish the results of this study can be applied in further research to help to improve the quality of ECMO care.
- Conditions
- Heart Failure, Respiratory Failure
- Being tested
- Extra-corporeal membrane oxygenation life support
- Medical subject headings
- Heart Failure, Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extra-corporeal membrane oxygenation life supportDevice
venoarterial extra-corporeal membrane oxygenation life support
| Study group | Role | What they receive |
|---|---|---|
| 28-day Survival | survive for at least 28 days after placement of extra-corporeal membrane oxygenation life support Receives: Device: Extra-corporeal membrane oxygenation life support | |
| 28-day Nonsurvival | not survive for 28 days after placement of extra-corporeal membrane oxygenation life support Receives: Device: Extra-corporeal membrane oxygenation life support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perfused small vessel density
Perfused small vessel density measured by incident dark field video microscope
Measured: At enrollment (within 12 hour after placement of extra-corporeal membrane oxygenation life support)
Secondary outcomes (3)
Total small vessel density
Total small vessel density measured by incident dark field video microscope
Measured: At Enrollment
Endocan level
Measured: At enrollment
Microvascular flow index
Microvascular flow index measured by incident dark field video microscope
Measured: At enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2015 (estimated)
- Study startApr 2015
- Primary completionAug 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies 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
- Prospective
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yu-Chang Yeh, MD, PhD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02393274
- Sponsor's protocol ID
- 201412045RINA
- Status last verified
- Dec 2016
- First submitted
- 15 Mar 2015
- Last updated
- 23 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Yeh YC, Lee CT, Wang CH, Tu YK, Lai CH, Wang YC, Chao A, Huang CH, Cheng YJ, Chen YS; NTUH Center of Microcirculation Medical Research (NCMMR). Investigation of microcirculation in patients with venoarterial extracorporeal membrane oxygenation life support. Crit Care. 2018 Aug 19;22(1):200. doi: 10.1186/s13054-018-2081-2.
PubMed 30121090
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Microcirculation in Patients With Venoarterial Extracorporeal Membrane Oxygenation Life Support
- ClinicalTrials.gov ID
- NCT02393274
- Acronym / sponsor ID
- 201412045RINA
- Conditions
- Heart Failure, Respiratory Failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Aug 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 19 Mar 2015 (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.
Extra-corporeal membrane oxygenation (ECMO) life support system can provide both cardiac and respiratory support to patients with heart and respiratory failure. It can save time for these organs to recovery or for these patients to receive further management. However, many patients will die in spite of ECMO support. One of the key factor is whether the blood flow provided by the ECMO can meet the requirement of organ perfusion. The adequacy of macrocirculation may be determined by arterial pressure and minute blood flow of ECMO. However, the adequacy of microcirculation remains as a major unresolved clinical problem. This is a prospective observational clinical trial. The sublingual microcirculation will be examined with the incident dark field video microscope within 6 hours after venoarterial ECMO placement, and then at 24 h, 48 h, 72 h, and 96 h. The severity of multiple organ injury and clinical data will be recorded as well. The major parameters of microcirculation include total small vessel density, perfused small vessel density, and microvascular flow index. The sublingual microcirculation will also be examined before weaning off ECMO, within 6 hours after ECMO removal, and then at 24 h, 48 h, and 72 h. Serum level of endothelial cell specific molecule-1 at specific time points will be examined. The data of 14-day mortality, 28-day mortality, duration of ECMO support, and intensive care unit stay will be recorded. This study aims primarily to investigate the relationship between microcirculation and prognosis of these patients. This study will also investigate the relationship among serum level of endothelial cell specific molecule-1, microcirculation, and prognosis of these patients. Wish the results of this study can be applied in further research to help to improve the quality of ECMO care.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 28-day Survival | – | Device: Extra-corporeal membrane oxygenation life supportsurvive for at least 28 days after placement of extra-corporeal membrane oxygenation life support |
| 28-day Nonsurvival | – | Device: Extra-corporeal membrane oxygenation life supportnot survive for 28 days after placement of extra-corporeal membrane oxygenation life support |
Who may qualify
- Ages
- 20 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who require venoarterial extra-corporeal membrane oxygenation (ECMO) life support
Key inclusion criteria (1 listed)
- Patients who require venoarterial extra-corporeal membrane oxygenation (ECMO) life support
Key exclusion criteria (2 listed)
- who can not take an examination of sublingual microcirculation within 6 hours after placement of venoarterial ECMO support
- Non-native speakers
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 |
|---|---|---|
| Extra-corporeal membrane oxygenation life supportvenoarterial extra-corporeal membrane oxygenation life support | Device | 28-day Nonsurvival, 28-day Survival |
Primary outcome
Perfused small vessel density
Time frame: At enrollment (within 12 hour after placement of extra-corporeal membrane oxygenation life support)
Perfused small vessel density measured by incident dark field video microscope
3 secondary outcomes
Total small vessel density
Time frame: At Enrollment
Endocan level
Time frame: At enrollment
Microvascular flow index
Time frame: At enrollment
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 23 Apr 2018.
- Derived from this study: PubMed 30121090Yeh YC, Lee CT, Wang CH, Tu YK, Lai CH, Wang YC, Chao A, Huang CH, Cheng YJ, Chen YS; NTUH Center of Microcirculation Medical Research (NCMMR). Investigation of microcirculation in patients with venoarterial extracorporeal membrane oxygenation life support. Crit Care. 2018 Aug 19;22(1):200. doi: 10.1186/s13054-018-2081-2.
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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.
Yu-Chang Yeh, MD, PhD 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 Heart Failure and Respiratory Failure, 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 1 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: finished, as of the sponsor's last update on 23 Apr 2018. 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?
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?
Perfused small vessel density (time frame: At enrollment (within 12 hour after placement of extra-corporeal membrane oxygenation life support)). 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 NCT02393274, which also lists 1 linked publication.
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 23 Apr 2018.