| PURPOSE:
BACKGROUND:
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Approximately 519,000 coronary artery bypass graft (CABG) procedures and 87,000 valve procedures were performed in the United States in 2000 on patients undergoing cardiopulmonary bypass (CPB). Although the mortality associated with CPB is relatively low (reported to be about 3-6% in multiple series), there is significant morbidity associated with CPB surgery, including myocardial infarction, arrhythmia, low-output state, respiratory failure and renal failure requiring dialysis.
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Natrecor (Nesiritide) for injection is approved in the U.S. for treatment of acute decompensated heart failure in patients with dyspnea at rest. It has been shown to reduce PAP and pulmonary capillary wedge pressure (PCWP), and increase diuresis without increasing heart rate or inducing arrhythmias, when used to treat decompensated CHF. Nesiritide also exerts coronary vasodilator effects on both the coronary conductance and resistance arteries without increasing myocardial oxygen demand as demonstrated by increased coronary artery blood flow and decreased coronary resistance at the recommended venous dose.
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In clinical studies, Natrecor has demonstrated a diuretic and natriuretic effect while maintaining or improving glomerular filtration rate (GFR). Nesiritide also exerts coronary vasodilator effects on both the coronary conductance and increased coronary artery blood flow and decreased coronary resistance at the recommended intravenous (IV) dose. The beneficial hemodynamic effects of Nesiritide could modulate the severity of many of the reported morbidities associated with CPB, but there has never been a study to demonstrate the effect of Nesiritide in the Perioperative period.
CRITERIA FOR INCLUSION OF SUBJECTS:
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The study population will consist of adult patients 18 years of age or older who are undergoing CABG surgery, and who will be placed on CPB during surgery.
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The inclusion criteria includes: NYHA class II-IV CHF; presenting for CABG with or without mitral valve repair or replacement procedure, planned utilization of CPB, documentation of left ventricular ejection fraction (LVEF) 35% or less as measured by nuclear scan, echocardiogram (ECHO), or ventriculogram, within 30 days prior to surgery.
CRITERIA FOR EXCLUSION OF SUBJECTS:
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Planned aortic valve replacement or repair, ongoing or chronic dialysis (either hemodialysis or continuous ambulatory peritoneal dialysis) and restrictive or obstructive cardiomyopathy, constrictive pericarditis, pericardial tamponade, or other conditions in which cardiac output is dependent on venous return
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Documented or suspected low cardiac filling pressures
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Any known congenital heart disease, known allergic reaction or sensitivity to Nesiritide or excipients, females of childbearing potential with a positive serum pregnancy test, nursing mothers, patients treated with an investigational drug or device within the last 30days, unless approval for inclusion is obtained from the sponsor
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Documented fever greater than 101 F within 72 hours of surgery, WBC greater 15,000 within 72 hours of surgery
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Documented bacterial/fungal/viral infection requiring administration of IV antibiotics within 7 days prior to surgery
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Patients with pulmonary disease (COPD, asthma, or other condition that has req1uired inpatient medical or surgical treatment) within 60 days prior to surgery,
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Planned ventricular aneurysmectomy
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Serum creatinine less than 1.0 mg/dl for men or less than 0.8 mg/dl for women
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Treatment exclusion criteria- obtained after anesthesia induction and before chest incision, prior to the start of study drug: a mean PAP less or equal to 15mm Hg., CVP less than 6 mm Hg., SBP consistently less than 90 mm Hg.
RECRUITMENT OF SUBJECTS:
For more information, please contact Nicklett Johnston, R.N. at 214-645-7728.
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