Analysis of Endotoxin Activity in Patients With ECMO

Study Overview
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Brief Summary
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Extra-corporeal membrane oxygenation (ECMO) can temporarily help patients gain time to wait for cardiopulmonary recovery or further treatment in patients with cardiopulmonary failure. Whether the blood flow provided by the ECMO can maintain the perfusion of various organs is an important factor affecting survival. Some ECMO patients died after the complication of sepsis. Our previous pilot analysis has recognized several ECMO patients with complicated sepsis has high endotoxin activity level. Endotoxemia can also occur in heart surgery and after cardiopulmonary bypass, trauma, organ transplantation, and out-of-hospital cardiac arrest patients. These trials used endotoxin activity analysis (EAA, EAATM, Spectral Diagnostics Inc., Canada) to analyze endotoxin activity. In addition, studies have indicated that the combination of procalcitonin (PCT) concentration and EAA activity can improve the accuracy of predicting sepsis. The primary aim of this study is to detect endotoxin activity in patients with ECMO support and compare whether the prognosis was associated with different level of EAA activity. The secondary aims are to analyze the risk factors leading to high EAA activity and investigate the diagnostic value of septic shock combining PCT examination. We suggest that the results of this study may help the ECMO medical team identify patients at high risk for septic shock and conduct adequate managements to improve patient survival and quality of life after survival.

Official Title
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Analysis of Endotoxin Activity in Patients With Extracorporeal Membrane Oxygenation Life Support System

Conditions
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Cardiovascular Shock, Respiratory Failure

Intervention / Treatment
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* Device: Extra-corporeal membrane oxygenation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients with ECMO support Exclusion Criteria: < 20 years old or > 90 years old not be able to collect blood sample within 48 hours after placement of ECMO change plan to palliative care and plan to remove ECMO non-native speakers

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ECMO patients<br>Patients with ECMO support | Device: Extra-corporeal membrane oxygenation<br>* Cardiovascular shock patients received extra-corporeal membrane oxygenation suppot.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endotoxin activity level | Endotoxin activity level is measured by endotoxin activity analysis kit | within 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endotoxin activity level | Endotoxin activity level is measured by endotoxin activity analysis kit | within 24 hours | 
| Endotoxin activity level | Endotoxin activity level is measured by endotoxin activity analysis kit | within 72 hours | 
| Endotoxin activity level | Endotoxin activity level is measured by endotoxin activity analysis kit | within 96 hours | 
| Procalcitonin level | Procalcitonin level in ECMO patients | within 48 hours | 
| Cystatin C level | Cytatin C level in ECMO patients | within 48 hours | 
| Diamine oxidase level | Diamine oxidase level in ECMO patients | within 48 hours |