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Ischaemia-réperfusion During the Coronary Surgery With Beating Heart

NCT01771978 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2013-01-18

No results posted yet for this study

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.

Conditions

  • Ischaemia-reperfusion Injury

Interventions

DRUG

Placebo

Received 250 ml of a 5% dextrose solution as placebo

DRUG

Diltiazem

Received a 100 µg/kg bolus followed by a 0.3 µg/kg infusion diluted in 250 ml of 5% dextrose solution

DRUG

Acetylcystein

Received 150 mg/kg acetylcystein diluted in 250 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

Sponsors & Collaborators

  • University Hospital, Strasbourg, France

    lead OTHER

Principal Investigators

  • Annick Steib, MD, PhD · Strasbourg University Hospital, France

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
60 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-06-30
Primary Completion
2008-02-29

Countries

  • France

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01771978 on ClinicalTrials.gov