TY - JOUR
T1 - A randomized, blinded trial of the antioxidant pegorgotein
T2 - No reduction in neuropsychological deficits, inotropic drug support, or myocardial ischemia after coronary artery bypass surgery
AU - Butterworth, John
AU - Legault, Claudine
AU - Stump, David A.
AU - Coker, Laura
AU - Mammon, John W.
AU - Todd Troost, B.
AU - Royster, Roger L.
AU - Prough, Donald S.
PY - 1999/12
Y1 - 1999/12
N2 - Objective: To determine whether patients receiving pegorgotein preoperatively would be less likely than patients receiving placebo to demonstrate postoperative cerebral or myocardial dysfunction and thus would be less likely to (1) demonstrate a decline in neuropsychologic testing after cardiopulmonary bypass, (2) receive inotropic drug support, or (3) demonstrate electrocardiographic signs of ischemia or infarction. Design: Prospective, randomized, blinded clinical trial. Setting: University teaching hospital and clinics. Participants: Sixty-seven patients with normal left ventricular function undergoing elective, primary coronary artery bypass surgery. Interventions: Six to 18 hours before aortic crossclamping, patients received a single dose of placebo (n = 22); pegorgotein, 2,000 IU/kg intravenously (n = 23); or pegorgotein, 5,000 IU/kg intravenously (n = 22). Measurements and Main Results: Patients in the three groups were similar; the mean ages were 65, 66, and 67 years, and there were seven, eight, and seven women in the placebo; pegorgotein, 2,000 IU/kg; and pegorgotein, 5,000 IU/kg groups. Fifty-one of 67 patients demonstrated neuropsychologic deficit 5 to 7 days postoperatively (n = 17, 19, and 15 for placebo, 2,000 IU/kg, and 5,000 IU/kg; p = NS). Median duration of cardiopulmonary bypass was longer in patients with two or more deficits at 4 to 6 weeks than in those with fewer than two deficits (121 v 98 minutes; p = 0.04). No patient demonstrated a perioperative stroke. Twenty-seven patients required inotropic drug support after cardiopulmonary bypass (n = 8, 11, and 8 for placebo, 2,000 IU/kg, and 5,000 IU/kg; p = NS). Inotropic drug support was associated with history of angina (p = 0.01) and increasing weight (p = 0.03). Nine patients demonstrated early postoperative ischemia or infarction (n = 1, 7, and 1 for placebo, 2,000 IU/kg, and 5,000 IU/kg; p = 0.07). Conclusions: This study showed no positive influence of pegorgotein on the incidence of any of the findings and showed a trend toward an increased incidence of myocardial ischemia or infarction.
AB - Objective: To determine whether patients receiving pegorgotein preoperatively would be less likely than patients receiving placebo to demonstrate postoperative cerebral or myocardial dysfunction and thus would be less likely to (1) demonstrate a decline in neuropsychologic testing after cardiopulmonary bypass, (2) receive inotropic drug support, or (3) demonstrate electrocardiographic signs of ischemia or infarction. Design: Prospective, randomized, blinded clinical trial. Setting: University teaching hospital and clinics. Participants: Sixty-seven patients with normal left ventricular function undergoing elective, primary coronary artery bypass surgery. Interventions: Six to 18 hours before aortic crossclamping, patients received a single dose of placebo (n = 22); pegorgotein, 2,000 IU/kg intravenously (n = 23); or pegorgotein, 5,000 IU/kg intravenously (n = 22). Measurements and Main Results: Patients in the three groups were similar; the mean ages were 65, 66, and 67 years, and there were seven, eight, and seven women in the placebo; pegorgotein, 2,000 IU/kg; and pegorgotein, 5,000 IU/kg groups. Fifty-one of 67 patients demonstrated neuropsychologic deficit 5 to 7 days postoperatively (n = 17, 19, and 15 for placebo, 2,000 IU/kg, and 5,000 IU/kg; p = NS). Median duration of cardiopulmonary bypass was longer in patients with two or more deficits at 4 to 6 weeks than in those with fewer than two deficits (121 v 98 minutes; p = 0.04). No patient demonstrated a perioperative stroke. Twenty-seven patients required inotropic drug support after cardiopulmonary bypass (n = 8, 11, and 8 for placebo, 2,000 IU/kg, and 5,000 IU/kg; p = NS). Inotropic drug support was associated with history of angina (p = 0.01) and increasing weight (p = 0.03). Nine patients demonstrated early postoperative ischemia or infarction (n = 1, 7, and 1 for placebo, 2,000 IU/kg, and 5,000 IU/kg; p = 0.07). Conclusions: This study showed no positive influence of pegorgotein on the incidence of any of the findings and showed a trend toward an increased incidence of myocardial ischemia or infarction.
KW - Coronary artery bypass grafting
KW - Ischemia-reperfusion injury
KW - Outcomes
KW - Superoxide dismutase
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U2 - 10.1016/S1053-0770(99)90121-0
DO - 10.1016/S1053-0770(99)90121-0
M3 - Article
C2 - 10622650
AN - SCOPUS:0033406116
SN - 1053-0770
VL - 13
SP - 690
EP - 694
JO - Journal of Cardiothoracic and Vascular Anesthesia
JF - Journal of Cardiothoracic and Vascular Anesthesia
IS - 6
ER -