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CompletedNCT03470792Updated Mar 12, 2021

Effects of Microcirculation-assisted Adjustment of Blood Flow of VA-ECMO on Prognosis

An interventional study of Microcirculation examination in Microcirculation and Extracorporeal Membrane Oxygenation, sponsored by National Taiwan University Hospital. Completed at 1 site in Taiwan. Open to participants aged 20 Years to 89 Years. Per ClinicalTrials.gov, last updated 2021-03-12.

Sponsored by National Taiwan University Hospital · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
20 Years to 89 Years
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Microcirculation
  • Extracorporeal Membrane Oxygenation

Keywords

  • Microcirculation, extracorporeal membrane oxygenation
03

Who can participate

Ages eligible
20 Years to 89 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • patients with venoarterial extra-corporeal membrane oxygenation

Exclusion criteria

Exclusion Criteria:

  • unable to receive microcirculation within 18 hours after placement of venoarterial extra-corporeal membrane oxygenation
  • non-native speakers and family
04

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
50 participants (actual)

Study arms

  • Experimental
    Microcirculation-assisted

    ECMO blood flow will be adjusted by conventional clinical conditions, hemodynamic parameters and microcirculation parameters

    Device: Microcirculation examination

  • Active comparator
    Control

    ECMO blood flow will be adjusted by clinical conditions and conventional hemodynamic parameters

    Device: Microcirculation examination

Interventions

  • DeviceMicrocirculation examination

    Sublingual microcirculation images were recorded using an incident dark-field video microscope

05

What researchers measure

Primary outcomes

  1. Lactate

    The difference of lactate level between Microcirculation-assisted group and control group

    Time frame: 24h

Secondary outcomes

  1. Lactate

    The difference of lactate level between Microcirculation-assisted group and control group

    Time frame: 48h

  2. Lactate

    The difference of lactate level between Microcirculation-assisted group and control group

    Time frame: 72h

  3. perfused small vessel density

    The difference of perfused small vessel density between Microcirculation-assisted group and control group

    Time frame: 24h

  4. perfused small vessel density

    The difference of perfused small vessel density between Microcirculation-assisted group and control group

    Time frame: 48h

  5. perfused small vessel density

    The difference of perfused small vessel density between Microcirculation-assisted group and control group

    Time frame: 72h

  6. endocan level

    The difference of endocan level between Microcirculation-assisted group and control group

    Time frame: 24h

  7. diamine oxidase level

    The difference of diamine oxidase level between Microcirculation-assisted group and control group

    Time frame: 24h

  8. inotropic score

    The difference of inotropic score between Microcirculation-assisted group and control group

    Time frame: 24h

06

Study locations

1 site
  • National Taiwan University Hospital
    Taipei, 100, Taiwan
07

Registry details

Key details

Study ID
NCT03470792
Lead sponsor
National Taiwan University Hospital
Responsible party
Sponsor
First posted
Mar 20, 2018
Start date
Dec 19, 2018
Primary completion
Jan 18, 2021
Completion
Feb 2, 2021
Last update
Mar 12, 2021

Study contacts

Yu-Chang Yeh, MD, PhD
principal investigator · National Taiwan University Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
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