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

NCT03470792 | Completed

• 1 other identifier: 201712044RINC
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Microcirculation, extracorporeal membrane oxygenation

Outcome Measures

Primary Outcomes (1)

• Lactate

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

  24h

Secondary Outcomes (8)

• Lactate

  48h

• Lactate

  72h

• perfused small vessel density

  24h

• perfused small vessel density

  48h

• perfused small vessel density

  72h

Study Arms (2)

Microcirculation-assisted

EXPERIMENTAL

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

Device: Microcirculation examination

Control

ACTIVE COMPARATOR

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

Device: Microcirculation examination

Interventions

Microcirculation examination DEVICE

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

Control; Microcirculation-assisted

Eligibility Criteria

• Age: 20 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients with venoarterial extra-corporeal membrane oxygenation

You may not qualify if:

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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

Study Officials

• Yu-Chang Yeh, MD, PhD

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2018
• First Posted: March 20, 2018
• Study Start: December 19, 2018
• Primary Completion: January 18, 2021
• Study Completion: February 2, 2021
• Last Updated: March 12, 2021

Record last verified: 2021-03

Locations

TW (1)