Microcirculation in Venoarterial Extracorporeal Membrane Oxygenation Life Support

Investigation of Microcirculation in Patients With Venoarterial Extracorporeal Membrane Oxygenation Life Support

Extra-corporeal membrane oxygenation (ECMO) life support system can provide both cardiac and respiratory support to patients with heart and respiratory failure. It can save time for these organs to recovery or for these patients to receive further management. However, many patients will die in spite of ECMO support. One of the key factor is whether the blood flow provided by the ECMO can meet the requirement of organ perfusion. The adequacy of macrocirculation may be determined by arterial pressure and minute blood flow of ECMO. However, the adequacy of microcirculation remains as a major unresolved clinical problem. This is a prospective observational clinical trial. The sublingual microcirculation will be examined with the incident dark field video microscope within 6 hours after venoarterial ECMO placement, and then at 24 h, 48 h, 72 h, and 96 h. The severity of multiple organ injury and clinical data will be recorded as well. The major parameters of microcirculation include total small vessel density, perfused small vessel density, and microvascular flow index. The sublingual microcirculation will also be examined before weaning off ECMO, within 6 hours after ECMO removal, and then at 24 h, 48 h, and 72 h. Serum level of endothelial cell specific molecule-1 at specific time points will be examined. The data of 14-day mortality, 28-day mortality, duration of ECMO support, and intensive care unit stay will be recorded. This study aims primarily to investigate the relationship between microcirculation and prognosis of these patients. This study will also investigate the relationship among serum level of endothelial cell specific molecule-1, microcirculation, and prognosis of these patients. Wish the results of this study can be applied in further research to help to improve the quality of ECMO care.

Study Overview

• Status: Completed
• Conditions: Heart Failure; Respiratory Failure
• Intervention / Treatment: Device: Extra-corporeal membrane oxygenation life support

• Study Type: Observational
• Enrollment (Actual): 48

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 100
    • National Taiwan University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients who require venoarterial extra-corporeal membrane oxygenation (ECMO) life support

Description

Inclusion Criteria:

• Patients who require venoarterial extra-corporeal membrane oxygenation (ECMO) life support

Exclusion Criteria:

• who can not take an examination of sublingual microcirculation within 6 hours after placement of venoarterial ECMO support
• Non-native speakers

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
28-day Survival; survive for at least 28 days after placement of extra-corporeal membrane oxygenation life support	Device: Extra-corporeal membrane oxygenation life support; venoarterial extra-corporeal membrane oxygenation life support
28-day Nonsurvival; not survive for 28 days after placement of extra-corporeal membrane oxygenation life support	Device: Extra-corporeal membrane oxygenation life support; venoarterial extra-corporeal membrane oxygenation life support

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perfused small vessel density	Perfused small vessel density measured by incident dark field video microscope	At enrollment (within 12 hour after placement of extra-corporeal membrane oxygenation life support)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total small vessel density	Total small vessel density measured by incident dark field video microscope	At Enrollment
Endocan level		At enrollment
Microvascular flow index	Microvascular flow index measured by incident dark field video microscope	At enrollment

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital

Publications and helpful links

General Publications

• Yeh YC, Lee CT, Wang CH, Tu YK, Lai CH, Wang YC, Chao A, Huang CH, Cheng YJ, Chen YS; NTUH Center of Microcirculation Medical Research (NCMMR). Investigation of microcirculation in patients with venoarterial extracorporeal membrane oxygenation life support. Crit Care. 2018 Aug 19;22(1):200. doi: 10.1186/s13054-018-2081-2.

Study record dates

Study Major Dates

• Study Start: April 1, 2015
• Primary Completion (Actual): August 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: March 15, 2015
• First Submitted That Met QC Criteria: March 15, 2015
• First Posted (Estimate): March 19, 2015

Study Record Updates

• Last Update Posted (Actual): April 23, 2018
• Last Update Submitted That Met QC Criteria: April 19, 2018
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency
• Other Study ID Numbers: 201412045RINA