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Completed

NCT Number: NCT03978728

Analysis of Endotoxin Activity in Patients With ECMO

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Extra-corporeal membrane oxygenation

Device

Cardiovascular shock patients received extra-corporeal membrane oxygenation suppot.

Primary outcomes

  1. Endotoxin activity level

    Time frame: within 48 hours

    Endotoxin activity level is measured by endotoxin activity analysis kit

Secondary outcomes

  1. Endotoxin activity level

    Time frame: within 24 hours

    Endotoxin activity level is measured by endotoxin activity analysis kit

  2. Endotoxin activity level

    Time frame: within 72 hours

    Endotoxin activity level is measured by endotoxin activity analysis kit

  3. Endotoxin activity level

    Time frame: within 96 hours

    Endotoxin activity level is measured by endotoxin activity analysis kit

  4. Procalcitonin level

    Time frame: within 48 hours

    Procalcitonin level in ECMO patients

  5. Cystatin C level

    Time frame: within 48 hours

    Cytatin C level in ECMO patients

  6. Diamine oxidase level

    Time frame: within 48 hours

    Diamine oxidase level in ECMO patients

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jun 7, 2019
Registry last updated
Feb 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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