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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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01089036
Acronym
ECMO
Enrollment
100
Registered
2010-03-18
Start date
2010-03-31
Completion date
2016-12-31
Last updated
2013-10-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Myocardial Infarction, Cardiogenic Shock, Cardiomyopathy, Myocarditis

Keywords

ECMO, cardiogenic shock, ROS, GPx, cytokines

Brief 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.

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.

Interventions

None listed

Sponsors

National Taiwan University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Mortality or multi-organ failure7 daysPatients 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.

Countries

Taiwan

Contacts

Primary ContactWen-Je Ko, MD, PhD
kowj@ntu.edu.tw0972651415

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026