Nitrite Mediated Cardioprotection During Coronary Artery Bypass Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2012-07-31

Brief Summary

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The purpose of this study is to determine whether sodium nitrite administration 24 hours prior to or during coronary artery bypass surgery protects the heart better from lack of blood flow which occurs as part of this type of operation. The study will also determine what the mechanisms of this cardioprotection are.

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Detailed Description

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In recent years, there has been much interest in sodium nitrite as a cytoprotective agent in in vitro and animal models. A recent study undertaken in a canine model of myocardial infarction demonstrated a 50% reduction in myocardial injury following the administration of sodium nitrite prior to the ischemic event. In humans, the setting of coronary artery bypass surgery lends itself well to study potential cytoprotective agents. During cardiac surgery, the heart undergoes a period of ischemia allowing the surgeons to operate on the heart. This is followed by a period of reperfusion which in itself can add to cellular injury. Such injury can hinder post-operative myocardial recovery.

The aim of this pilot study is to determine whether the cardioprotective effects of sodium nitrite demonstrated in animal models are translated in humans and to determine the exact underlying mechanisms of this cytoprotection. Patients undergoing coronary artery bypass grafting surgery who give written, informed consent will receive sodium nitrite 24 hours prior to surgery, during cardiac surgery or placebo. Myocardial injury will be assessed through the measurement of biochemical markers such as troponin T. Cardiac biopsy samples will be obtained to determine underlying molecular mechanisms of this cardioprotection. The other aim of this pilot study is to determine what dose of sodium nitrite (i.e. 0.2mcg/kg/min or 1mcg/kg/min) is optimal for cardioprotection. This study will form pilot data also for a larger clinical trial with clinical endpoints.

Conditions

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Coronary Artery Bypass Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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sodium nitrite 24 hours before

Group Type EXPERIMENTAL

sodium nitrite

Intervention Type DRUG

0.2mcg/kg/min or 1mcg/kg/min intravenous for 30minutes at 1ml/min

sodium nitrite during surgery

Group Type EXPERIMENTAL

sodium nitrite

Intervention Type DRUG

0.2mcg/kg/min or 1mcg/kg/min intravenous for 30minutes at 1ml/min

0.9% sodium chloride

Group Type PLACEBO_COMPARATOR

0.9% sodium chloride

Intervention Type DRUG

intravenous 0.9% sodium chloride over 30minutes at 1ml/min

Interventions

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sodium nitrite

0.2mcg/kg/min or 1mcg/kg/min intravenous for 30minutes at 1ml/min

Intervention Type DRUG

0.9% sodium chloride

intravenous 0.9% sodium chloride over 30minutes at 1ml/min

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients undergoing elective first time multi-vessel coronary artery bypass surgery
* Older than 18 years of age

Exclusion Criteria

* Significant psychiatric /neurological impairment that might prevent adherence to the requirements of the protocol or the ability to give informed consent
* Inability to read the Information Sheet.
* Redo operation
* Age \>80 years
* Pregnancy
* Renal Impairment requiring pre-operative renal support
* Diabetes Mellitus
* Intended heart valve or additional surgery
* Episodes of angina or ischemia within 48hours prior to the procedure

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No