Effects of Diltiazem and/or N-Acétylcystéine Versus Placebo on hémodynamiques and Biological Repercussions of the Ischaemia-réperfusion During the Coronary Surgery With Beating Heart
Sponsor study identifier
interventional
120
1 country
1
Study Start
June 2002
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
February 2008
Actual (reported)Study Completion
Not reported
Date not reportedLess oxidative stress occurs during off-pump than on-pump coronary artery bypass graft (CABG) surgery but warm ischaemia-reperfusion injury may occur following transient coronary artery clamping. The aim of this study was to compare the preventive effects of diltiazem and N-acetylcysteine (NAC), alone or in combination, on biomarkers of myocardial damage and oxidative stress during off-pump CABG surgery.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
Not reported
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 2002
Date type not reportedThis date has not been verified as actual or estimated.
February 2008
Actual (reported)December 27, 2012
Actual (reported)January 18, 2013
Actual (reported)Reduce the percentage 40% of patients operated on a beating heart to 10% as a result of treatment with diltiazem and N-acetylcysteine
Choosing as main biological variable rate cTnI cardiospecific, above the threshold of detection (0.3 mcg / L) in 40% of patients operated on a beating heart hoping to reduce this percentage to 10% as a result of treatment with diltiazem and N-acetylcysteine
during ischaemia-reperfusion
Received 250 ml of a 5% dextrose solution as placebo drug
Received a 100 µg/kg bolus followed by a 0.3 µg/kg infusion diluted in 250 ml of 5% dextrose solution
Received 150 mg/kg acetylcystein diluted in 250 ml of 5% dextrose solution
Received 250 ml of a 5% dextrose solution as placebo
Received a 100 µg/kg bolus followed by a 0.3 µg/kg infusion diluted in 250 ml of 5% dextrose solution
Department of Anaesthesiology
Strasbourg, 67091, France
Annick Steib, MD, PhD
Strasbourg University Hospital, France
First Submitted
December 27, 2012
First Posted
January 18, 2013
Study Start
June 2002
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
February 2008
Actual (reported)Atrial Fibrillation Follow-up Investigation of Rhythm Management (AFFIRM)
Received a combination of drug : bolus diltiazem 100 µg/kg followed by a 0.3 µg/kg infusion diluted in 125 ml of a 5% dextrose solution and 150 mg/kg acetylcystein diluted in 125 ml of 5% dextrose solution
Received 150 mg/kg acetylcystein diluted in 250 ml of 5% dextrose solution
Received a combination of drug :diltiazem and acetylcystein * bolus diltiazem 100 µg/kg followed by a 0.3 µg/kg infusion diluted in 125 ml of a 5% dextrose solution * 150 mg/kg acetylcystein diluted in 125 ml of 5% dextrose solution
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Last Updated
January 18, 2013
Record last verified: 2008-02
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Source: ClinicalTrials.gov.
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