Analysis of Endotoxin Activity in Patients With ECMO

Completed

• Conditions: Respiratory Failure; Cardiovascular Shock
• Interventions: Device: Extra-corporeal membrane oxygenation

• Registration Number: NCT03978728
• Lead Sponsor: National Taiwan University Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-06-02
• Study First Submitted QC: 2019-06-05
• Study First Posted: 2019-06-07
• Study Start: 2019-08-21
• Primary Completion: 2021-01-18
• Study Completion: 2021-02-28
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-07
• Last Update Posted: 2022-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

Inclusion Criteria

• patients with ECMO support

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ECMO patients	Extra-corporeal membrane oxygenation	Patients with ECMO support

Primary Outcome Measures

Name	Time	Method
Endotoxin activity level	within 48 hours	Endotoxin activity level is measured by endotoxin activity analysis kit

Secondary Outcome Measures

Name	Time	Method
Diamine oxidase level	within 48 hours	Diamine oxidase level in ECMO patients
Cystatin C level	within 48 hours	Cytatin C level in ECMO patients
Endotoxin activity level	within 96 hours	Endotoxin activity level is measured by endotoxin activity analysis kit
Procalcitonin level	within 48 hours	Procalcitonin level in ECMO patients

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan