Analysis of Endotoxin Activity in Patients With ECMO

Respiratory Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03978728
• Other study ID #: 201811061RINC
• Status: Completed
• Start date: August 21, 2019
• Est. completion date: February 28, 2021

Study information

• Verified date: February 2022
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: February 28, 2021
• Est. primary completion date: January 18, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Shock
• Respiratory Failure
• Respiratory Insufficiency
• Shock, Cardiogenic

Intervention

Device:
• Extra-corporeal membrane oxygenation
Cardiovascular shock patients received extra-corporeal membrane oxygenation suppot.

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Endotoxin activity level	Endotoxin activity level is measured by endotoxin activity analysis kit	within 48 hours
Secondary	Endotoxin activity level	Endotoxin activity level is measured by endotoxin activity analysis kit	within 24 hours
Secondary	Endotoxin activity level	Endotoxin activity level is measured by endotoxin activity analysis kit	within 72 hours
Secondary	Endotoxin activity level	Endotoxin activity level is measured by endotoxin activity analysis kit	within 96 hours
Secondary	Procalcitonin level	Procalcitonin level in ECMO patients	within 48 hours
Secondary	Cystatin C level	Cytatin C level in ECMO patients	within 48 hours
Secondary	Diamine oxidase level	Diamine oxidase level in ECMO patients	within 48 hours