MicrocirculationNCT03470792
Effects of Microcirculation-assisted Adjustment of Blood Flow of VA-ECMO on Prognosis
A study testing Microcirculation examination in people with Microcirculation and Extracorporeal Membrane Oxygenation, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
One of the key factors of survival of patients with extra-corporeal membrane oxygenation (ECMO) life support system is whether the blood flow supplied by ECMO can meet the need of perfusion of each organ. Read more about this study
- Who is it for?
- Ages 20 to 89 years
- Conditions the study is for
- Microcirculation, Extracorporeal Membrane Oxygenation
- What is being tested?
- Microcirculation examination
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTaiwan
- Study dates
- 19 Dec 2018to 2 Feb 2021
- Phase
- Interventional
- 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 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with venoarterial extra-corporeal membrane oxygenation
Who cannot join
- unable to receive microcirculation within 18 hours after placement of venoarterial extra-corporeal membrane oxygenation
- non-native speakers and family
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Microcirculation-assisted Adjustment of Blood Flow of Venoarterial Extracorporeal Membrane Oxygenation Life Support System on Prognosis
One of the key factors of survival of patients with extra-corporeal membrane oxygenation (ECMO) life support system is whether the blood flow supplied by ECMO can meet the need of perfusion of each organ. In our previous study, we found that microcirculaton parameters within 12h after placement of venoarterial ECMO (VA-ECMO) were lower in the 28-day non-survivors than those in the survivors. Moreover, in our ongoing observational clinical trial, we found that adjustment of ECMO blood flow could improve microcirculatory dysfunction in some patients. We hypothesize that if we can find out the patients with poor microcirculation and use the microcirculation parameters to assist the adjustment of ECMO blood flow and related treatments, we might improve the survival of these patients. In this clinical trial, the patients will receive microcirculation examination within 18h after placement of ECMO. The patients were randomly divided into control and microcirculation-assisted groups. The microcirculation parameters in patients of the microcirculation-assisted group will be given to the ECMO team, and the ECMO blood flow and relative treatments will be adjusted according to macrocirculation parameters, clinical condition, and microcirculation parameters. In the patients of the control group, the ECMO blood flow and related treatments will be adjusted according to macrocirculation parameters and clinical condition. The microcirculation will be measured twice after T1, and the ECMO and related treatments will be adjusted as previous description. The microcirculation will be measured at 72h after placement of VA-ECMO. The ECMO setting, intake-output balance, dose of inotropic and vasopressors, and prognosis will be recorded. The difference will be compared between the two groups.
Read the detailed description
For severe cardiac and respiratory failure patients, extra-corporeal membrane oxygenation (ECMO) life support system can help them to have time to wait for the recovery of cardiac and respiratory function or receiving advanced managements. One of the key factors of survival is whether the blood flow supplied by ECMO can meet the need of perfusion of each organ. In our previous study, we found that perfused small vessel density and proportion of perfused small vessel within 18h after placement of venoarterial ECMO (VA-ECMO) were lower in the 28-day non-survivors than those in the survivors. In one research of goal-directed treatment of septic shock, it shows that early microcirculation improved more in the patients with mild organ failure at 24h than in the patients with severe organ failure at 24h. Moreover, in our ongoing observational clinical trial, we found that adjustment of ECMO blood flow could improve microcirculatory dysfunction in some patients. We hypothesize that if we can find out the patients with poor microcirculation and use the microcirculation parameters to assist the adjustment of ECMO blood flow and related treatments, we might improve the survival of these patients. In this clinical trial, the patients will receive microcirculation examination within 18h (T1) after placement of ECMO. The patients were randomly divided into control and microcirculation-assisted groups. The microcirculation parameters in patients of the microcirculation-assisted group will be given to the ECMO team, and the ECMO blood flow and relative treatments will be adjusted according to macrocirculation parameters, clinical condition, and microcirculation parameters. In the patients of the control group, the ECMO blood flow and related treatments will be adjusted according to macrocirculation parameters and clinical condition. The microcirculation will be measured again at 6-22h after T1 and 28-44h after T1, and the ECMO and related treatments will be adjusted as previous description. The microcirculation will be measured at 72h after placement of VA-ECMO. The ECMO setting, intake-output balance, dose of inotropic and vasopressors, and prognosis will be recorded. The difference will be compared between the two groups.
- Being tested
- Microcirculation examination
- Keywords
- Microcirculation, extracorporeal membrane oxygenation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microcirculation examinationDevice
Sublingual microcirculation images were recorded using an incident dark-field video microscope
| Study group | Role | What they receive |
|---|---|---|
| Microcirculation-assisted | Experimental | ECMO blood flow will be adjusted by conventional clinical conditions, hemodynamic parameters and microcirculation parameters Receives: Device: Microcirculation examination |
| Control | Active comparator | ECMO blood flow will be adjusted by clinical conditions and conventional hemodynamic parameters Receives: Device: Microcirculation examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lactate
The difference of lactate level between Microcirculation-assisted group and control group
Measured: 24h
Secondary outcomes (8)
Lactate
The difference of lactate level between Microcirculation-assisted group and control group
Measured: 48h
Lactate
The difference of lactate level between Microcirculation-assisted group and control group
Measured: 72h
perfused small vessel density
The difference of perfused small vessel density between Microcirculation-assisted group and control group
Measured: 24h
perfused small vessel density
The difference of perfused small vessel density between Microcirculation-assisted group and control group
Measured: 48h
perfused small vessel density
The difference of perfused small vessel density between Microcirculation-assisted group and control group
Measured: 72h
endocan level
The difference of endocan level between Microcirculation-assisted group and control group
Measured: 24h
diamine oxidase level
The difference of diamine oxidase level between Microcirculation-assisted group and control group
Measured: 24h
inotropic score
The difference of inotropic score between Microcirculation-assisted group and control group
Measured: 24h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2018
- Study start19 Dec 2018
- Primary completion18 Jan 2021
- Study completion2 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MicrocirculationStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 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
- NCT03470792
- Sponsor's protocol ID
- 201712044RINC
- Status last verified
- Mar 2021
- First submitted
- 13 Mar 2018
- Last updated
- 12 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Microcirculation-assisted Adjustment of Blood Flow of Venoarterial Extracorporeal Membrane Oxygenation Life Support System on Prognosis
- ClinicalTrials.gov ID
- NCT03470792
- Acronym / sponsor ID
- 201712044RINC
- Keywords
- Microcirculation, extracorporeal membrane oxygenation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 19 Dec 2018 (actual)
- Primary completion
- 18 Jan 2021 (actual)
- Study completion
- 2 Feb 2021 (actual)
- First posted
- 20 Mar 2018 (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.
One of the key factors of survival of patients with extra-corporeal membrane oxygenation (ECMO) life support system is whether the blood flow supplied by ECMO can meet the need of perfusion of each organ. In our previous study, we found that microcirculaton parameters within 12h after placement of venoarterial ECMO (VA-ECMO) were lower in the 28-day non-survivors than those in the survivors. Moreover, in our ongoing observational clinical trial, we found that adjustment of ECMO blood flow could improve microcirculatory dysfunction in some patients. We hypothesize that if we can find out the patients with poor microcirculation and use the microcirculation parameters to assist the adjustment of ECMO blood flow and related treatments, we might improve the survival of these patients. In this clinical trial, the patients will receive microcirculation examination within 18h after placement of ECMO. The patients were randomly divided into control and microcirculation-assisted groups. The microcirculation parameters in patients of the microcirculation-assisted group will be given to the ECMO team, and the ECMO blood flow and relative treatments will be adjusted according to macrocirculation parameters, clinical condition, and microcirculation parameters. In the patients of the control group, the ECMO blood flow and related treatments will be adjusted according to macrocirculation parameters and clinical condition. The microcirculation will be measured twice after T1, and the ECMO and related treatments will be adjusted as previous description. The microcirculation will be measured at 72h after placement of VA-ECMO. The ECMO setting, intake-output balance, dose of inotropic and vasopressors, and prognosis will be recorded. The difference will be compared between the two groups.
Detailed description
For severe cardiac and respiratory failure patients, extra-corporeal membrane oxygenation (ECMO) life support system can help them to have time to wait for the recovery of cardiac and respiratory function or receiving advanced managements. One of the key factors of survival is whether the blood flow supplied by ECMO can meet the need of perfusion of each organ. In our previous study, we found that perfused small vessel density and proportion of perfused small vessel within 18h after placement of venoarterial ECMO (VA-ECMO) were lower in the 28-day non-survivors than those in the survivors. In one research of goal-directed treatment of septic shock, it shows that early microcirculation improved more in the patients with mild organ failure at 24h than in the patients with severe organ failure at 24h. Moreover, in our ongoing observational clinical trial, we found that adjustment of ECMO blood flow could improve microcirculatory dysfunction in some patients. We hypothesize that if we can find out the patients with poor microcirculation and use the microcirculation parameters to assist the adjustment of ECMO blood flow and related treatments, we might improve the survival of these patients. In this clinical trial, the patients will receive microcirculation examination within 18h (T1) after placement of ECMO. The patients were randomly divided into control and microcirculation-assisted groups. The microcirculation parameters in patients of the microcirculation-assisted group will be given to the ECMO team, and the ECMO blood flow and relative treatments will be adjusted according to macrocirculation parameters, clinical condition, and microcirculation parameters. In the patients of the control group, the ECMO blood flow and related treatments will be adjusted according to macrocirculation parameters and clinical condition. The microcirculation will be measured again at 6-22h after T1 and 28-44h after T1, and the ECMO and related treatments will be adjusted as previous description. The microcirculation will be measured at 72h after placement of VA-ECMO. The ECMO setting, intake-output balance, dose of inotropic and vasopressors, and prognosis will be recorded. The difference will be compared between the two groups.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Microcirculation-assisted | Experimental | Device: Microcirculation examinationECMO blood flow will be adjusted by conventional clinical conditions, hemodynamic parameters and microcirculation parameters |
| Control | Active comparator | Device: Microcirculation examinationECMO blood flow will be adjusted by clinical conditions and conventional hemodynamic parameters |
Who may qualify
- Ages
- 20 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients with venoarterial extra-corporeal membrane oxygenation
Key exclusion criteria (2 listed)
- unable to receive microcirculation within 18 hours after placement of venoarterial extra-corporeal membrane oxygenation
- non-native speakers and family
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 |
|---|---|---|
| Microcirculation examinationSublingual microcirculation images were recorded using an incident dark-field video microscope | Device | Control, Microcirculation-assisted |
Primary outcome
Lactate
Time frame: 24h
The difference of lactate level between Microcirculation-assisted group and control group
8 secondary outcomes
Lactate
Time frame: 48h
Lactate
Time frame: 72h
perfused small vessel density
Time frame: 24h
perfused small vessel density
Time frame: 48h
perfused small vessel density
Time frame: 72h
endocan level
Time frame: 24h
diamine oxidase level
Time frame: 24h
inotropic score
Time frame: 24h
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 12 Mar 2021.
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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?
A study testing Microcirculation examination in people with Microcirculation and Extracorporeal Membrane Oxygenation, 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 12 Mar 2021. 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?
Lactate (time frame: 24h). 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 12 Mar 2021.