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Ischaemia-réperfusion During the Coronary Surgery With Beating Heart

Primary Purpose

Ischaemia-reperfusion Injury

Status
Unknown status
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Placebo
Diltiazem
Acetylcystein
diltiazem and acetylcystein
Sponsored by
University Hospital, Strasbourg, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ischaemia-reperfusion Injury focused on measuring ischaemia-reperfusion injury, cardiac surgery, oxidative stress markers, troponin, diltiazem, acetylcystein

Eligibility Criteria

60 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Department of Anaesthesiology

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Arm Label

Arm1: control group

Arm 2: diltiazem group

Arm 3: acetylcystein group

Arm 4: diltiazem and acetylcystein group

Arm Description

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 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

Outcomes

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
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

Secondary Outcome Measures

Full Information

First Posted
December 27, 2012
Last Updated
January 16, 2013
Sponsor
University Hospital, Strasbourg, France
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1. Study Identification

Unique Protocol Identification Number
NCT01771978
Brief Title
Ischaemia-réperfusion During the Coronary Surgery With Beating Heart
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 Type
Interventional

2. Study Status

Record Verification Date
February 2008
Overall Recruitment Status
Unknown status
Study Start Date
June 2002 (undefined)
Primary Completion Date
February 2008 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Strasbourg, France

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischaemia-reperfusion Injury
Keywords
ischaemia-reperfusion injury, cardiac surgery, oxidative stress markers, troponin, diltiazem, acetylcystein

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm1: control group
Arm Type
Placebo Comparator
Arm Description
Received 250 ml of a 5% dextrose solution as placebo drug
Arm Title
Arm 2: diltiazem group
Arm Type
Experimental
Arm Description
Received a 100 µg/kg bolus followed by a 0.3 µg/kg infusion diluted in 250 ml of 5% dextrose solution
Arm Title
Arm 3: acetylcystein group
Arm Type
Experimental
Arm Description
Received 150 mg/kg acetylcystein diluted in 250 ml of 5% dextrose solution
Arm Title
Arm 4: diltiazem and acetylcystein group
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
placebo group
Intervention Description
Received 250 ml of a 5% dextrose solution as placebo
Intervention Type
Drug
Intervention Name(s)
Diltiazem
Other Intervention Name(s)
Diltiazem group
Intervention Description
Received a 100 µg/kg bolus followed by a 0.3 µg/kg infusion diluted in 250 ml of 5% dextrose solution
Intervention Type
Drug
Intervention Name(s)
Acetylcystein
Other Intervention Name(s)
Acetylcystein group
Intervention Description
Received 150 mg/kg acetylcystein diluted in 250 ml of 5% dextrose solution
Intervention Type
Drug
Intervention Name(s)
diltiazem and acetylcystein
Other Intervention Name(s)
Combined diltiazem and acetylcystein drug group
Intervention Description
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
Primary Outcome Measure Information:
Title
Reduce the percentage 40% of patients operated on a beating heart to 10% as a result of treatment with diltiazem and N-acetylcysteine
Description
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
Time Frame
during ischaemia-reperfusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Annick Steib, MD, PhD
Organizational Affiliation
Strasbourg University Hospital, France
Official's Role
Study Director
Facility Information:
Facility Name
Department of Anaesthesiology
City
Strasbourg
ZIP/Postal Code
67091
Country
France

12. IPD Sharing Statement

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Ischaemia-réperfusion During the Coronary Surgery With Beating Heart

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