Effects of Microcirculation-assisted Adjustment of Blood Flow of VA-ECMO on Prognosis
Condition: Microcirculation; Extracorporeal Membrane Oxygenation
Study type: Interventional

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.
    

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.
    

Intervention name(s): Microcirculation examination
Intervention type(s): Device
Intervention description(s): Sublingual microcirculation images were recorded using an incident dark-field video microscope
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Other
Keywords: Microcirculation, extracorporeal membrane oxygenation