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NCT Number: NCT02393274

Microcirculation in 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.

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Key information

Age range

20 year–79 year

Sex eligibility

All sexes

Study type

Observational

Primary location

National Taiwan University Hospital

Taipei, 100, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Extra-corporeal membrane oxygenation life support

Device

venoarterial extra-corporeal membrane oxygenation life support

Primary outcomes

  1. Perfused small vessel density

    Time frame: 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 outcomes

  1. Total small vessel density

    Time frame: At Enrollment

    Total small vessel density measured by incident dark field video microscope

  2. Endocan level

    Time frame: At enrollment

  3. Microvascular flow index

    Time frame: At enrollment

    Microvascular flow index measured by incident dark field video microscope

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Mar 19, 2015
Registry last updated
Apr 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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