Microcirculation in Venoarterial Extracorporeal Membrane Oxygenation Life Support

Completed

• Conditions: Respiratory Failure; Heart Failure
• Interventions: Device: Extra-corporeal membrane oxygenation life support

• Registration Number: NCT02393274
• Lead Sponsor: National Taiwan University Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-03-15
• Study First Submitted QC: 2015-03-15
• Study First Posted: 2015-03-19
• Study Start: 2015-04
• Primary Completion: 2016-08
• Status Verified: 2016-12
• Study Completion: 2016-12
• Last Update Submitted: 2018-04-19
• Last Update Posted: 2018-04-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
28-day Nonsurvival	Extra-corporeal membrane oxygenation life support	not survive for 28 days after placement of extra-corporeal membrane oxygenation life support
28-day Survival	Extra-corporeal membrane oxygenation life support	survive for at least 28 days after placement of extra-corporeal membrane oxygenation life support

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Total small vessel density	At Enrollment	Total small vessel density measured by incident dark field video microscope
Endocan level	At enrollment
Microvascular flow index	At enrollment	Microvascular flow index measured by incident dark field video microscope

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan