Cardiogenic ShockECMONCT01089036
Oxidant-antioxidant Activity, Free Radicle Activity, Immune Response and Biomarkers in Extracorporeal Membrane Oxygenation (ECMO) Patients
An observational study of Cardiogenic Shock and Acute Myocardial Infarction, run by National Taiwan University Hospital at 2 sites in Taiwan.
Trial summary
We would like to investigate novel diagnostic methods or biomarkers to early predict the success of ECMO therapy for cardiogenic shock patients during the early stage after ECMO treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiogenic Shock, Acute Myocardial Infarction, Myocarditis
- How many people
- 100 participants
- Where
- 2 sitesTaiwan
- Study dates
- Mar 2010to Dec 2016
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Inclusion criteria: 1. ≧ 18 yr. 2. cardiogenic shock, needing ECMO support Exclusion criteria 1. pre-existing sepsis 2. pre-existing chronic renal failure (dialysis dependent), liver failure, multiple organ failure
Who may be able to join
- 1. ≧ 18 yr. 2. cardiogenic shock, needing ECMO support
Who cannot join
- 1. pre-existing sepsis 2. pre-existing chronic renal failure (dialysis dependent), liver failure, multiple organ failure
Trial locations and contacts
2 sites in 1 country.
Taiwan2 sites, 2 recruiting
- Not yet recruiting
National Taiwan University Hospital
Taipei, Taiwan, 100
Wen-Je Ko, MD, PhD, 0972651415, kowj@ntu.edu.tw
Wen-Je Ko, MD, PhD
- Recruiting
National Taiwan University Hospital
Taipei, Taiwan, 100
Wen-Je Ko, MD, PhD, 0972651415, kowj@ntu.edu.tw
About this study
Official title: Oxidant-antioxidant Activity, Free Radicle Activity, Immune Response and Biomarkers in ECMO Patients
We would like to investigate novel diagnostic methods or biomarkers to early predict the success of ECMO therapy for cardiogenic shock patients during the early stage after ECMO treatment.
Read the detailed description
In the investigators previous study (Ann Thorac Surg 2002, 73: 538-545), the investigators knew that for those adult patients receiving ECMO support for post-cardiotomy cardiogenic shock, 1/3 of them would survive to discharge, 1/3 could not be weaned from ECMO and died on the ECMO support, and 1/3 could be weaned from ECMO support, but finally died of multiple organ failure. However, by clinical observation in the first few days of ECMO support, it would be very difficult to predict the outcome of a specified individual patient. Therefore, the investigators usually wait for four to six days to know whether the ECMO treatment is successful or not. If the investigators could predict the result one or two days earlier, this would give physicians enough time to make medical decision. Therefore, the early parameters that could be used to predict the outcome of ECMO treatment would be very valuable. The investigators also found that despite obscure clinical presentation, there was a significant difference in serum cytokines' concentration on the 3rd day of ECMO support between "ECMO successful" and "ECMO failure" patients.
In this study, the investigators will further investigate leukocyte free radical activity, oxidation damage marker (8-OHdG concentration) in serum, whole blood glutathione peroxidase activity for antioxidation, serum IL-6, IL-12, IL-8, IL-10, transforming growth factor-β and other biochemical concentrations and immune cellular changes during the period of ECMO treatment. Patient's blood samples before and 2, 6, 12, 24, 48, 72 hours after ECMO support treatment, at ECMO removal and ICU discharge will be collected and used for the study. The measured factors and the final outcome will be compared. The investigators hope to find early factors change during ECMO treatment among biochemical, immunological and clinical parameters.
- Keywords
- ECMO, cardiogenic shock, ROS, GPx, cytokines
- Medical subject headings
- Shock, Cardiogenic, Myocarditis, Cardiomyopathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| survival | ECMO survival patients | |
| ECMO non-survival | ECMO non-survivals |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality or multi-organ failure
Patients who survived for more than 7 days after ECMO treatment were defined as survival, and non-survival patients were defined as expired or multiple organ failure incompatible with life within 7 days after ECMO installation.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2010 (estimated)
- Study startMar 2010
- Primary completionDec 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiogenic 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wen-Je Ko, MD, PhD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01089036
- Sponsor's protocol ID
- 200911043R
- Acronym
- ECMO
- Status last verified
- Oct 2013
- First submitted
- 16 Mar 2010
- Last updated
- 21 Oct 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oxidant-antioxidant Activity, Free Radicle Activity, Immune Response and Biomarkers in ECMO Patients
- ClinicalTrials.gov ID
- NCT01089036
- Acronym / sponsor ID
- ECMO / 200911043R
- Keywords
- ECMO, cardiogenic shock, ROS, GPx, cytokines
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 18 Mar 2010 (estimated)
- 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.
We would like to investigate novel diagnostic methods or biomarkers to early predict the success of ECMO therapy for cardiogenic shock patients during the early stage after ECMO treatment.
Detailed description
In the investigators previous study (Ann Thorac Surg 2002, 73: 538-545), the investigators knew that for those adult patients receiving ECMO support for post-cardiotomy cardiogenic shock, 1/3 of them would survive to discharge, 1/3 could not be weaned from ECMO and died on the ECMO support, and 1/3 could be weaned from ECMO support, but finally died of multiple organ failure. However, by clinical observation in the first few days of ECMO support, it would be very difficult to predict the outcome of a specified individual patient. Therefore, the investigators usually wait for four to six days to know whether the ECMO treatment is successful or not. If the investigators could predict the result one or two days earlier, this would give physicians enough time to make medical decision. Therefore, the early parameters that could be used to predict the outcome of ECMO treatment would be very valuable. The investigators also found that despite obscure clinical presentation, there was a significant difference in serum cytokines' concentration on the 3rd day of ECMO support between "ECMO successful" and "ECMO failure" patients.
In this study, the investigators will further investigate leukocyte free radical activity, oxidation damage marker (8-OHdG concentration) in serum, whole blood glutathione peroxidase activity for antioxidation, serum IL-6, IL-12, IL-8, IL-10, transforming growth factor-β and other biochemical concentrations and immune cellular changes during the period of ECMO treatment. Patient's blood samples before and 2, 6, 12, 24, 48, 72 hours after ECMO support treatment, at ECMO removal and ICU discharge will be collected and used for the study. The measured factors and the final outcome will be compared. The investigators hope to find early factors change during ECMO treatment among biochemical, immunological and clinical parameters.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| survival | – | –ECMO survival patients |
| ECMO non-survival | – | –ECMO non-survivals |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Inclusion criteria: 1. ≧ 18 yr. 2. cardiogenic shock, needing ECMO support Exclusion criteria 1. pre-existing sepsis 2. pre-existing chronic renal failure (dialysis dependent), liver failure, multiple organ failure
Key inclusion criteria (1 listed)
- 1. ≧ 18 yr. 2. cardiogenic shock, needing ECMO support
Key exclusion criteria (1 listed)
- 1. pre-existing sepsis 2. pre-existing chronic renal failure (dialysis dependent), liver failure, multiple organ failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mortality or multi-organ failure
Time frame: 7 days
Patients who survived for more than 7 days after ECMO treatment were defined as survival, and non-survival patients were defined as expired or multiple organ failure incompatible with life within 7 days after ECMO installation.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2013.
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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.
Wen-Je Ko, MD, PhD principal investigator
National Taiwan University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiogenic Shock and Acute Myocardial Infarction, run by National Taiwan University Hospital at 2 sites 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 1 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: status not confirmed, as of the sponsor's last update on 21 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wen-Je Ko, MD, PhD (0972651415, kowj@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality or multi-organ failure (time frame: 7 days). 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 21 Oct 2013.