Ischaemia-réperfusion During the Coronary Surgery With Beating Heart

January 16, 2013 updated by: University Hospital, Strasbourg, France

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Strasbourg, France, 67091
        • Department of Anaesthesiology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • Combined diltiazem and acetylcystein drug group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
during ischaemia-reperfusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Strasbourg, France

Investigators

  • Study Director: Annick Steib, MD, PhD, Strasbourg University Hospital, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2002

Primary Completion (Actual)

February 1, 2008

Study Registration Dates

First Submitted

December 27, 2012

First Submitted That Met QC Criteria

January 16, 2013

First Posted (Estimate)

January 18, 2013

Study Record Updates

Last Update Posted (Estimate)

January 18, 2013

Last Update Submitted That Met QC Criteria

January 16, 2013

Last Verified

February 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2276

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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