A Phase 2 interventional study of sodium nitrite and 0.9% sodium chloride in Coronary Artery Bypass Surgery, sponsored by University Hospital Birmingham NHS Foundation Trust. Status unknown at 1 site in United Kingdom. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2010-04-02.
Sponsored by University Hospital Birmingham NHS Foundation Trust · Phase 2, Interventional, and Treatment
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.
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.
University Hospital Birmingham NHS Foundation Trust is the lead sponsor of 35 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: sodium nitrite
Drug: sodium nitrite
Drug: 0.9% sodium chloride
0.2mcg/kg/min or 1mcg/kg/min intravenous for 30minutes at 1ml/min
intravenous 0.9% sodium chloride over 30minutes at 1ml/min
Troponin T
Biochemical marker of myocardial injury
Time frame: 72 hours post release of aortic cross clamp
Troponin T
Time frame: 6 hours post release of aortic cross clamp
troponin T
Time frame: 12 hours post release of aortic cross clamp
Troponin T
Time frame: 24 hours post release of aortic cross clamp
Troponin T
Time frame: 48 hours post release of aortic cross clamp
Creatinine Kinase myocardial Fraction (CKMB)
Time frame: 6 hours post release of aortic cross clamp
Creatinine Kinase myocardial Fraction (CKMB)
Time frame: 12 hours post release of aortic cross clamp
Creatinine Kinase myocardial Fraction (CKMB)
Time frame: 24 hours post release of aortic cross clamp
Creatinine Kinase myocardial Fraction (CKMB)
Time frame: 48 hours post release of aortic cross clamp
Creatinine Kinase myocardial Fraction (CKMB)
Time frame: 72 hours post release of aortic cross clamp
venous methemoglobinaemia
study drug means both sodium nitrite and placebo
Time frame: immediately before infusion of study drug
plasma 8-isoprostane
Time frame: before aortic cross clamp administration
Nitric oxide metabolites in cardiac tissue
Time frame: before aortic cross clamp application
Cardiac output studies
Time frame: upto 12 hours after release of aortic cross clamp
inotrope usage
Time frame: up to 12 hours after release of aortic cross clamp
venous methemoglobinemia
Study drug could be sodium nitrite or placebo and each infusion last 30minutes.
Time frame: immediately after infusion of study drug.
Nitric oxide metabolites in cardiac tissue
Time frame: before release of aortic cross clamp
Nitric oxide metabolites in cardiac tissue
Time frame: 10minutes after release of aortic cross clamp
Plasma 8 isoprostane levels
Time frame: 5minutes after discontinuation of cardiopulmonary bypass
This study is status unknown, as verified in Jan 2010. You cannot join it, but the record below documents what was studied.
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University Hospital Birmingham NHS Foundation Trust