Clinical trial NCT02393274: Microcirculation in Venoarterial Extracorporeal Membrane Oxygenation Life Support
Official title: Investigation of Microcirculation in Patients With Venoarterial Extracorporeal Membrane Oxygenation Life Support
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Respiratory Failure
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2015-03-19
Enrollment: 48
Sex: ALL
Minimum age (years): 20
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who require venoarterial extra-corporeal membrane oxygenation (ECMO) life support

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.


Eligibility criteria: 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

Primary outcomes:
measure: Perfused small vessel density
timeFrame: At enrollment (within 12 hour after placement of extra-corporeal membrane oxygenation life support)
Secondary outcomes:
measure: Total small vessel density
timeFrame: At Enrollment
measure: Endocan level
timeFrame: At enrollment
measure: Microvascular flow index
timeFrame: At enrollment
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Yu-Chang Yeh, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.