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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00965445
Other study ID # CGMH-IRB-96-0019B
Secondary ID CGMH-IRB-96-0019
Status Completed
Phase N/A
First received August 23, 2009
Last updated August 24, 2009
Start date March 2007
Est. completion date December 2007

Study information

Verified date August 2009
Source Chang Gung Memorial Hospital
Contact n/a
Is FDA regulated No
Health authority Taiwan: Institutional Review Board
Study type Observational

Clinical Trial Summary

Oxidative stress is an unavoidable event during cardiac surgery. Isoprostanes have been demonstrated to be a reliable biomarker for the evaluation of oxidative stress in vivo.The aims of this study are(1)to develop an accurate liquid chromatography-tandem mass spectrometry methods for the detection of urinary isoprostane isomers in samples collected from healthy volunteers(for method quality control) and patients receiving a cardiac surgery (2)to investigate the change of isoprostanes after cardiopulmonary bypass(CPB) (3)to investigate the effect of different anesthetics on isoprostanes.


Description:

Enhanced production of oxygen free radicals can lead to the generation of oxidative stress, which is harmful to human tissue and organs. Reactive oxygen species are released abruptly during some surgical procedures, and they are the major causes of ischemia-reperfusion injuries.Isoprostanes have been demonstrated to be a reliable biomarker for the evaluation of oxidative stress in vivo. Therefore, accurately monitoring and avoiding the occurrence of oxidative stress during surgery is an important clinical issue.

Isoprostanes are a series of prostaglandin-like compounds produced by non-enzymatic peroxidation of arachidonic acid.The aims of this study are(1)to develop an accurate liquid chromatography-tandem mass spectrometry methods for the detection of urinary isoprostane isomers in samples collected from patients receiving a cardiac surgery (2)to investigate the change of isoprostanes after cardiopulmonary bypass (3)to investigate the effect of different anesthetics on isoprostanes during surgery.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date December 2007
Est. primary completion date December 2007
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 25 Years to 80 Years
Eligibility Inclusion Criteria:

- patients receiving cardiac valve surgery in ASA II-III physical status

Exclusion Criteria:

- trauma, infection, low ejection fraction (less than 25%), liver cirrhosis, or acute renal failure, and emergency surgery

Study Design

Observational Model: Case Control, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
Taiwan Dept. of Anesthesiology, Chang Gung Memorial Hospital Taipei

Sponsors (1)

Lead Sponsor Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary isoprostanes isomer as marker of oxidative stress one day No
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