Ischaemia-réperfusion During the Coronary Surgery With Beating Heart

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2008 by University Hospital, Strasbourg, France.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier:
NCT01771978
First received: December 27, 2012
Last updated: January 16, 2013
Last verified: February 2008
  Purpose

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 Intervention Phase
Ischaemia-reperfusion Injury
Drug: Placebo
Drug: Diltiazem
Drug: Acetylcystein
Drug: diltiazem and acetylcystein
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University Hospital, Strasbourg, France:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 120
Study Start Date: June 2002
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   60 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01771978

Locations
France
Department of Anaesthesiology
Strasbourg, France, 67091
Sponsors and Collaborators
University Hospital, Strasbourg, France
Investigators
Study Director: Annick Steib, MD, PhD Strasbourg University Hospital, France
  More Information

No publications provided

Responsible Party: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT01771978     History of Changes
Other Study ID Numbers: 2276
Study First Received: December 27, 2012
Last Updated: January 16, 2013
Health Authority: France: Ministry of Health

Keywords provided by University Hospital, Strasbourg, France:
ischaemia-reperfusion injury
cardiac surgery
oxidative stress markers
troponin
diltiazem
acetylcystein

Additional relevant MeSH terms:
Ischemia
Reperfusion Injury
Wounds and Injuries
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases
Postoperative Complications
Diltiazem
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Antihypertensive Agents
Vasodilator Agents

ClinicalTrials.gov processed this record on April 23, 2014