Circulatory FailureNCT03210818
Effects of Blood Flow of Venoarterial Extracorporeal Membrane Oxygenation Life Support on Microcirculation
An observational study of Circulatory 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 patients to regain organ function or to receive transplantation. Both the investigators' team and Ince et al. Read more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- Circulatory Failure
- What is being tested?
- Extra-corporeal membrane oxygenation life support
- Type of treatment
- Medical device
- How many people
- 28 participants
- Where
- 1 siteTaiwan
- Study dates
- 5 Nov 2017to 30 Apr 2019
- 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 90 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 24 hours after placement of venoarterial ECMO support
- Non-native speakers
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Adjustment of Blood Flow of Venoarterial Extracorporeal Membrane Oxygenation Life Support on Microcirculation
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 patients to regain organ function or to receive transplantation. Both the investigators' team and Ince et al. from the Netherland found that the microcirculatory dysfunction is more severe in ECMO non-survivors. The next step of research is to find out the key factors that affect microcirculation in ECMO patients. Because the blood flow supplied by the venoarterial ECMO (VA-ECMO) is directly related to macrocirculation, this study aims to investigate the effect of adjustment of VA-ECMO blood flow on microcirculation. The investigators hope that the results of this study can help the medical team to improve the quality of ECMO care.
Read the detailed description
After evaluation, explanation, and acquisition of agreement, the sublingual microcirculation will be examined within 24 h and at 48 h after placement of VA-ECMO. The VA-ECMO blood flow will be recorded, and the baseline microcirculation will be examined. After the ECMO technician adjusting the ECMO flow, sublingual microcirculation will be examined 2 minutes after each adjustment, and the change of ECMO blood flow will be recorded. When the ECMO team plans to weaning off the ECMO within 72 h, the sublingual microcirculation will be examined. The VA-ECMO blood flow will be reduced by ECMO technician, and sublingual microcirculation will be examined 2 minutes after each adjustment of the blood flow. The ECMO parameters, medications, and clinical data will be recorded, and the prognosis will be followed up on the 28th day.
- Conditions
- Circulatory Failure
- Being tested
- Extra-corporeal membrane oxygenation life support
- Medical subject headings
- Shock
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
Adjustment of blood flow of 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 [PSVD] measured by incident dark field video microscope
Measured: Difference of PSVD between before and after adjustment of VA-ECMO blood flow within 24 hours after placement of VA-ECMO
Secondary outcomes (4)
Perfused small vessel density
Perfused small vessel density [PSVD] measured by incident dark field video microscope
Measured: Difference of PSVD between before and after adjustment of VA-ECMO blood flow on day 2 after placement of VA-ECMO
Perfused small vessel density
Perfused small vessel density measured by incident dark field video Perfused small vessel density [PSVD] measured by incident dark field video
Measured: Difference of PSVD between before and after adjustment of VA-ECMO blood flow within anticipated 72 hours before removal of VA-ECMO
Total small vessel density
Total small vessel density [TSVD] measured by incident dark field video microscope
Measured: Difference of TSVD between before and after adjustment of VA-ECMO blood flow within 24 hours after placement of VA-ECMO
Proportion of perfused vessel
Proportion of perfused vessel (PPV): TSVD/PSVD X 100
Measured: Difference of PPV between before and after adjustment of VA-ECMO blood flow within 24 hours after placement of VA-ECMO
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2017
- Study start5 Nov 2017
- Primary completion3 Dec 2018
- Study completion30 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Circulatory 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
- 28 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
- NCT03210818
- Sponsor's protocol ID
- 201703011RINA
- Status last verified
- Jul 2018
- First submitted
- 2 Jul 2017
- Last updated
- 9 May 2019
- Results posted
- No
- Data monitoring committee
- No
- 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 9 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Adjustment of Blood Flow of Venoarterial Extracorporeal Membrane Oxygenation Life Support on Microcirculation
- ClinicalTrials.gov ID
- NCT03210818
- Acronym / sponsor ID
- 201703011RINA
- Conditions
- Circulatory Failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 5 Nov 2017 (actual)
- Primary completion
- 3 Dec 2018 (actual)
- Study completion
- 30 Apr 2019 (actual)
- First posted
- 7 Jul 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.
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 patients to regain organ function or to receive transplantation. Both the investigators' team and Ince et al. from the Netherland found that the microcirculatory dysfunction is more severe in ECMO non-survivors. The next step of research is to find out the key factors that affect microcirculation in ECMO patients. Because the blood flow supplied by the venoarterial ECMO (VA-ECMO) is directly related to macrocirculation, this study aims to investigate the effect of adjustment of VA-ECMO blood flow on microcirculation. The investigators hope that the results of this study can help the medical team to improve the quality of ECMO care.
Detailed description
After evaluation, explanation, and acquisition of agreement, the sublingual microcirculation will be examined within 24 h and at 48 h after placement of VA-ECMO. The VA-ECMO blood flow will be recorded, and the baseline microcirculation will be examined. After the ECMO technician adjusting the ECMO flow, sublingual microcirculation will be examined 2 minutes after each adjustment, and the change of ECMO blood flow will be recorded. When the ECMO team plans to weaning off the ECMO within 72 h, the sublingual microcirculation will be examined. The VA-ECMO blood flow will be reduced by ECMO technician, and sublingual microcirculation will be examined 2 minutes after each adjustment of the blood flow. The ECMO parameters, medications, and clinical data will be recorded, and the prognosis will be followed up on the 28th day.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 90 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 24 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 supportAdjustment of blood flow of extra-corporeal membrane oxygenation life support | Device | – |
Primary outcome
Perfused small vessel density
Time frame: Difference of PSVD between before and after adjustment of VA-ECMO blood flow within 24 hours after placement of VA-ECMO
Perfused small vessel density [PSVD] measured by incident dark field video microscope
4 secondary outcomes
Perfused small vessel density
Time frame: Difference of PSVD between before and after adjustment of VA-ECMO blood flow on day 2 after placement of VA-ECMO
Perfused small vessel density
Time frame: Difference of PSVD between before and after adjustment of VA-ECMO blood flow within anticipated 72 hours before removal of VA-ECMO
Total small vessel density
Time frame: Difference of TSVD between before and after adjustment of VA-ECMO blood flow within 24 hours after placement of VA-ECMO
Proportion of perfused vessel
Time frame: Difference of PPV between before and after adjustment of VA-ECMO blood flow within 24 hours after placement of VA-ECMO
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 9 May 2019.
- 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.
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 Circulatory 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 9 May 2019. 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: Difference of PSVD between before and after adjustment of VA-ECMO blood flow within 24 hours after placement of VA-ECMO). 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 9 May 2019.