An observational study in Heart Failure and Respiratory Failure, sponsored by National Taiwan University Hospital. Completed at 1 site in Taiwan. Open to participants aged 20 Years to 79 Years. Per ClinicalTrials.gov, last updated 2018-04-23.
Sponsored by National Taiwan University Hospital · Observational
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.
1,650 studies on the registry are indexed under Respiratory Insufficiency; 296 are open to participants now.
This study's enrollment of 48 is below the median of 100 across 545 observational studies indexed under Respiratory Insufficiency.
Browse Respiratory Insufficiency studies →National Taiwan University Hospital is the lead sponsor of 2,563 studies on the registry; 569 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 2 (18%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients who require venoarterial extra-corporeal membrane oxygenation (ECMO) life support
Exclusion Criteria:
survive for at least 28 days after placement of extra-corporeal membrane oxygenation life support
Device: Extra-corporeal membrane oxygenation life support
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
Perfused small vessel density
Perfused small vessel density measured by incident dark field video microscope
Time frame: At enrollment (within 12 hour after placement of extra-corporeal membrane oxygenation life support)
Total small vessel density
Total small vessel density measured by incident dark field video microscope
Time frame: At Enrollment
Endocan level
Time frame: At enrollment
Microvascular flow index
Microvascular flow index measured by incident dark field video microscope
Time frame: At enrollment
This study is completed, as verified in Dec 2016. You cannot join it, but the record below documents what was studied.
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National Taiwan University Hospital