Oxidant-antioxidant Activity, Free Radicle Activity, Immune Response and Biomarkers in Extracorporeal Membrane Oxygenation (ECMO) Patients
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Purpose
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, TGF-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.
| Condition |
|---|
|
Free Radical Activity Oxidation Damage Marker Glutathione Peroxidase Activity for Antioxidation IL-6, IL-12, TGF-β and Other Biochemical Concentrations Immune Cellular Changes |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Prospective |
| Official Title: | Oxidant-antioxidant Activity, Free Radicle Activity, Immune Response and Biomarkers in ECMO Patients |
- free radical activity [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- oxidation damage marker [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- whole blood glutathione peroxidase activity [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- serum IL-6, IL-12, TGF-β and other biochemicals [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- immune cellular changes [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
serum,plasma, and cells for study. Once the study is completed, biospecimen will be discarded.
| Estimated Enrollment: | 100 |
| Study Start Date: | March 2010 |
| Estimated Study Completion Date: | December 2016 |
| Estimated Primary Completion Date: | December 2016 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
survival
ECMO survival patients
|
|
ECMO non-survival
ECMO non-survivals
|
Detailed Description:
We would like to investigate novel diagnostic methods or biomarkers to early predict the success of ECMO therapy during the early stage after ECMO treatment.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Inclusion criteria:
- ≧ 18 yr.
- cardiogenic shock, needing ECMO support
Exclusion criteria
- pre-existing sepsis
- pre-existing chronic renal failure (dialysis dependent), liver failure, multiple organ failure
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
Contacts and Locations| Contact: Wen-Je Ko, MD, PhD | 0972651415 | kowj@ntu.edu.tw |
| Taiwan | |
| National Taiwan University Hospital | Not yet recruiting |
| Taipei, Taiwan, 100 | |
| Contact: Wen-Je Ko, MD, PhD 0972651415 kowj@ntu.edu.tw | |
| Principal Investigator: Wen-Je Ko, MD, PhD | |
| National Taiwan University Hospital | Recruiting |
| Taipei, Taiwan, 100 | |
| Contact: Wen-Je Ko, MD, PhD 0972651415 kowj@ntu.edu.tw | |
| Principal Investigator: | Wen-Je Ko, MD, PhD | National Taiwan University Hospital |
More Information
No publications provided
| Responsible Party: | National Taiwan University Hospital |
| ClinicalTrials.gov Identifier: | NCT01089036 History of Changes |
| Other Study ID Numbers: | 200911043R |
| Study First Received: | March 16, 2010 |
| Last Updated: | November 14, 2012 |
| Health Authority: | Taiwan: Department of Health |
Keywords provided by National Taiwan University Hospital:
|
ECMO cardiogenic shock ROS GPx cytokines |
Additional relevant MeSH terms:
|
Antioxidants Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Protective Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on June 18, 2013