Analysis of Endotoxin Activity in Patients With ECMO

February 7, 2022 updated by: National Taiwan University Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

55

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan
        • National Taiwan University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Paitents with extra-corporeal membrane oxygenation support

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
ECMO patients
Patients with ECMO support
Device: Extra-corporeal membrane oxygenation
Cardiovascular shock patients received extra-corporeal membrane oxygenation suppot.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 21, 2019

Primary Completion (Actual)

January 18, 2021

Study Completion (Actual)

February 28, 2021

Study Registration Dates

First Submitted

June 2, 2019

First Submitted That Met QC Criteria

June 5, 2019

First Posted (Actual)

June 7, 2019

Study Record Updates

Last Update Posted (Actual)

February 9, 2022

Last Update Submitted That Met QC Criteria

February 7, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201811061RINC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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