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

NCT03470792 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2021-03-12

No results posted yet for this 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.

Conditions

  • Microcirculation
  • Extracorporeal Membrane Oxygenation

Interventions

DEVICE

Microcirculation examination

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

Sponsors & Collaborators

  • National Taiwan University Hospital

    lead OTHER

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
89 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-19
Primary Completion
2021-01-18
Completion
2021-02-02

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03470792 on ClinicalTrials.gov