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Ischaemia-réperfusion During the Coronary Surgery With Beating Heart

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ClinicalTrials.gov Identifier: NCT01771978
Recruitment Status : Unknown
Verified February 2008 by University Hospital, Strasbourg, France.
Recruitment status was:  Active, not recruiting
First Posted : January 18, 2013
Last Update Posted : January 18, 2013
Sponsor:
Information provided by (Responsible Party):
University Hospital, Strasbourg, France

Study Description
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Brief Summary:
Less 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.

Condition or disease Intervention/treatment Phase
Ischaemia-reperfusion Injury Drug: Placebo Drug: Diltiazem Drug: Acetylcystein Drug: diltiazem and acetylcystein Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : June 2002
Actual Primary Completion Date : February 2008

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Arm1: control group
Received 250 ml of a 5% dextrose solution as placebo drug
 Drug: Placebo
Received 250 ml of a 5% dextrose solution as placebo
Other Name: placebo group
Experimental: Arm 2: diltiazem group
Received a 100 µg/kg bolus followed by a 0.3 µg/kg infusion diluted in 250 ml of 5% dextrose solution
 Drug: Diltiazem
Received a 100 µg/kg bolus followed by a 0.3 µg/kg infusion diluted in 250 ml of 5% dextrose solution
Other Name: Diltiazem group
Experimental: Arm 3: acetylcystein group
Received 150 mg/kg acetylcystein diluted in 250 ml of 5% dextrose solution
 Drug: Acetylcystein
Received 150 mg/kg acetylcystein diluted in 250 ml of 5% dextrose solution
Other Name: Acetylcystein group
Experimental: Arm 4: diltiazem and acetylcystein group

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

 Drug: diltiazem and acetylcystein

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
Other Name: Combined diltiazem and acetylcystein drug group


Outcome Measures
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Primary Outcome Measures :
  1. Reduce the percentage 40% of patients operated on a beating heart to 10% as a result of treatment with diltiazem and N-acetylcysteine [ Time Frame: during ischaemia-reperfusion ]
    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


Eligibility Criteria
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Ages Eligible for Study:   60 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age included between 60 and 80 years

Exclusion Criteria:

  • Age < 60 or > 80 years
  • Pregnancy
  • The allergy in used medicines (N-acétylcystéine, Diltiazem)
  • Presence of a pathology valvulaire associated
  • Urgency
  • Unstable angor
  • Bypass as a matter of urgency
  • Recours peropératoire to a CEC
  • FE < 0,40
  • BAV of the 2nd and 3rd not sailed degree
  • fibrillation or flutter little finger.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01771978


Locations
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France
Department of Anaesthesiology
Strasbourg, France, 67091
Sponsors and Collaborators
University Hospital, Strasbourg, France
Investigators
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Study Director: Annick Steib, MD, PhD Strasbourg University Hospital, France
More Information
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Responsible Party: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT01771978    
Other Study ID Numbers: 2276
First Posted: January 18, 2013    Key Record Dates
Last Update Posted: January 18, 2013
Last Verified: February 2008
Keywords provided by University Hospital, Strasbourg, France:
ischaemia-reperfusion injury
cardiac surgery
oxidative stress markers
 troponin
diltiazem
acetylcystein
Additional relevant MeSH terms:
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Reperfusion Injury
Ischemia
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases
Postoperative Complications
Diltiazem
 Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vasodilator Agents