Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03470792 |
| Other study ID # |
201712044RINC |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
December 19, 2018 |
| Est. completion date |
February 2, 2021 |
Study information
| Verified date |
March 2021 |
| Source |
National Taiwan University Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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. 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.
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.
