Cardiovascular ShockNCT03978728
Analysis of Endotoxin Activity in Patients With ECMO
An observational study of Cardiovascular Shock and Respiratory Failure, run by National Taiwan University Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- Cardiovascular Shock, Respiratory Failure
- What is being tested?
- Extra-corporeal membrane oxygenation
- Type of treatment
- Medical device
- How many people
- 55 participants
- Where
- 1 siteTaiwan
- Study dates
- 21 Aug 2019to 28 Feb 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Paitents with extra-corporeal membrane oxygenation support
Who may be able to join
- patients with ECMO support
Who cannot join
- < 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Cardiovascular Shock, Respiratory Failure
- Being tested
- Extra-corporeal membrane oxygenation
- Medical subject headings
- Shock, Cardiogenic, Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extra-corporeal membrane oxygenationDevice
Cardiovascular shock patients received extra-corporeal membrane oxygenation suppot.
| Study group | Role | What they receive |
|---|---|---|
| ECMO patients | Patients with ECMO support Receives: Device: Extra-corporeal membrane oxygenation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endotoxin activity level
Endotoxin activity level is measured by endotoxin activity analysis kit
Measured: within 48 hours
Secondary outcomes (6)
Endotoxin activity level
Endotoxin activity level is measured by endotoxin activity analysis kit
Measured: within 24 hours
Endotoxin activity level
Endotoxin activity level is measured by endotoxin activity analysis kit
Measured: within 72 hours
Endotoxin activity level
Endotoxin activity level is measured by endotoxin activity analysis kit
Measured: within 96 hours
Procalcitonin level
Procalcitonin level in ECMO patients
Measured: within 48 hours
Cystatin C level
Cytatin C level in ECMO patients
Measured: within 48 hours
Diamine oxidase level
Diamine oxidase level in ECMO patients
Measured: within 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2019
- Study start21 Aug 2019
- Primary completion18 Jan 2021
- Study completion28 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular ShockStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yu-Chang Yeh, MD, PhD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03978728
- Sponsor's protocol ID
- 201811061RINC
- Status last verified
- Feb 2022
- First submitted
- 2 Jun 2019
- Last updated
- 9 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Endotoxin Activity in Patients With Extracorporeal Membrane Oxygenation Life Support System
- ClinicalTrials.gov ID
- NCT03978728
- Acronym / sponsor ID
- 201811061RINC
- Conditions
- Cardiovascular Shock, Respiratory Failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 21 Aug 2019 (actual)
- Primary completion
- 18 Jan 2021 (actual)
- Study completion
- 28 Feb 2021 (actual)
- First posted
- 7 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ECMO patients | – | Device: Extra-corporeal membrane oxygenationPatients with ECMO support |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Paitents with extra-corporeal membrane oxygenation support
Key inclusion criteria (1 listed)
- patients with ECMO support
Key exclusion criteria (4 listed)
- < 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Extra-corporeal membrane oxygenationCardiovascular shock patients received extra-corporeal membrane oxygenation suppot. | Device | ECMO patients |
Primary outcome
Endotoxin activity level
Time frame: within 48 hours
Endotoxin activity level is measured by endotoxin activity analysis kit
6 secondary outcomes
Endotoxin activity level
Time frame: within 24 hours
Endotoxin activity level
Time frame: within 72 hours
Endotoxin activity level
Time frame: within 96 hours
Procalcitonin level
Time frame: within 48 hours
Cystatin C level
Time frame: within 48 hours
Diamine oxidase level
Time frame: within 48 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yu-Chang Yeh, MD, PhD principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Shock and Respiratory Failure, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endotoxin activity level (time frame: within 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2022.