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Analysis of Endotoxin Activity in Patients With ECMO

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03978728
Enrollment
55
Registered
2019-06-07
Start date
2019-08-21
Completion date
2021-02-28
Last updated
2022-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Shock, Respiratory Failure

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.

Interventions

Cardiovascular shock patients received extra-corporeal membrane oxygenation suppot.

Sponsors

National Taiwan University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Years to 90 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Endotoxin activity levelwithin 48 hoursEndotoxin activity level is measured by endotoxin activity analysis kit

Secondary

MeasureTime frameDescription
Endotoxin activity levelwithin 24 hoursEndotoxin activity level is measured by endotoxin activity analysis kit
Procalcitonin levelwithin 48 hoursProcalcitonin level in ECMO patients
Cystatin C levelwithin 48 hoursCytatin C level in ECMO patients
Diamine oxidase levelwithin 48 hoursDiamine oxidase level in ECMO patients

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026