Clinical trial NCT01089036: Oxidant-antioxidant Activity, Free Radicle Activity, Immune Response and Biomarkers in Extracorporeal Membrane Oxygenation (ECMO) Patients
Official title: Oxidant-antioxidant Activity, Free Radicle Activity, Immune Response and Biomarkers in ECMO Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cardiogenic Shock
Acute Myocardial Infarction
Myocarditis
Cardiomyopathy
Keywords: ECMO
cardiogenic shock
ROS
GPx
cytokines
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2010-03-18
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Mortality or multi-organ failure
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Wen-Je Ko, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: