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

• Conditions: Cardiomyopathy; Myocarditis; Cardiogenic Shock; Acute Myocardial Infarction

• Registration Number: NCT01089036
• Lead Sponsor: National Taiwan University Hospital

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.

Study Timeline

• Study Start: 2010-03
• Study First Submitted: 2010-03-16
• Study First Submitted QC: 2010-03-17
• Study First Posted: 2010-03-18
• Status Verified: 2013-10
• Last Update Submitted: 2013-10-18
• Last Update Posted: 2013-10-21
• Primary Completion: 2016-12
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• 1. ≧ 18 yr. 2. cardiogenic shock, needing ECMO support

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Exclusion Criteria

• 1. pre-existing sepsis 2. pre-existing chronic renal failure (dialysis dependent), liver failure, multiple organ failure

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mortality or multi-organ failure	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.

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan