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Oxidant-antioxidant Activity, Free Radicle Activity, Immune Response and Biomarkers in Extracorporeal Membrane Oxygenation (ECMO) Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by National Taiwan University Hospital
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT01089036
First received: March 16, 2010
Last updated: October 18, 2013
Last verified: October 2013

March 16, 2010
October 18, 2013
March 2010
December 2016   (final data collection date for primary outcome measure)
Mortality or multi-organ failure [ Time Frame: 7 days ] [ Designated as safety issue: No ]
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.
  • 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 ]
Complete list of historical versions of study NCT01089036 on ClinicalTrials.gov Archive Site
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Oxidant-antioxidant Activity, Free Radicle Activity, Immune Response and Biomarkers in Extracorporeal Membrane Oxygenation (ECMO) Patients
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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

serum,plasma, and cells for study. Once the study is completed, biospecimen will be discarded.

Non-Probability Sample

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
  • Cardiogenic Shock
  • Acute Myocardial Infarction
  • Myocarditis
  • Cardiomyopathy
Not Provided
  • survival
    ECMO survival patients
  • ECMO non-survival
    ECMO non-survivals
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
December 2016
December 2016   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Wen-Je Ko, MD, PhD 0972651415 kowj@ntu.edu.tw
Taiwan
 
NCT01089036
200911043R
Yes
National Taiwan University Hospital
National Taiwan University Hospital
Not Provided
Principal Investigator: Wen-Je Ko, MD, PhD National Taiwan University Hospital
National Taiwan University Hospital
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP