A randomized, blinded trial of the antioxidant pegorgotein

No reduction in neuropsychological deficits, inotropic drug support, or myocardial ischemia after coronary artery bypass surgery

John Butterworth, Claudine Legault, David A. Stump, Laura Coker, John W. Mammon, B. Todd Troost, Roger L. Royster, Donald Prough

Research output: Contribution to journalArticle

26 Citations (Scopus)

Abstract

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.

Original languageEnglish (US)
Pages (from-to)690-694
Number of pages5
JournalJournal of Cardiothoracic and Vascular Anesthesia
Volume13
Issue number6
StatePublished - Dec 1999
Externally publishedYes

Fingerprint

Coronary Artery Bypass
Myocardial Ischemia
Antioxidants
Pharmaceutical Preparations
Placebos
Cardiopulmonary Bypass
Infarction
Ischemia
polyethylene glycol-superoxide dismutase
Incidence
Left Ventricular Function
Teaching Hospitals
Randomized Controlled Trials
Stroke
Myocardial Infarction
Weights and Measures

Keywords

  • Coronary artery bypass grafting
  • Ischemia-reperfusion injury
  • Outcomes
  • Superoxide dismutase

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

A randomized, blinded trial of the antioxidant pegorgotein : No reduction in neuropsychological deficits, inotropic drug support, or myocardial ischemia after coronary artery bypass surgery. / Butterworth, John; Legault, Claudine; Stump, David A.; Coker, Laura; Mammon, John W.; Todd Troost, B.; Royster, Roger L.; Prough, Donald.

In: Journal of Cardiothoracic and Vascular Anesthesia, Vol. 13, No. 6, 12.1999, p. 690-694.

Research output: Contribution to journalArticle

Butterworth, John ; Legault, Claudine ; Stump, David A. ; Coker, Laura ; Mammon, John W. ; Todd Troost, B. ; Royster, Roger L. ; Prough, Donald. / A randomized, blinded trial of the antioxidant pegorgotein : No reduction in neuropsychological deficits, inotropic drug support, or myocardial ischemia after coronary artery bypass surgery. In: Journal of Cardiothoracic and Vascular Anesthesia. 1999 ; Vol. 13, No. 6. pp. 690-694.
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abstract = "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.",
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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

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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.

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KW - Coronary artery bypass grafting

KW - Ischemia-reperfusion injury

KW - Outcomes

KW - Superoxide dismutase

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