A randomized, blinded trial of the antioxidant pegorgotein: no reduction in neuropsychological deficits, inotropic drug support, or myocardial ischemia after coronary artery bypass surgery.
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.


METHODS
Prospective, randomized, blinded clinical trial.


METHODS
University teaching hospital and clinics.


METHODS
Sixty-seven patients with normal left ventricular function undergoing elective, primary coronary artery bypass surgery.


METHODS
Six to 18 hours before aortic cross-clamping, 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).


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.
Butterworth
J
J
Department of Anesthesiology, Wake Forest University School of Medicine, Winston-Salem, NC 27157-1009, USA.
Legault
C
C
Stump
D A
DA
Coker
L
L
Hammon
J W
JW
Troost
B T
BT
Royster
R L
RL
Prough
D S
DS
D000368:Aged; D000975:Antioxidants / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002315:Cardiopulmonary Bypass; D002316:Cardiotonic Agents / Q000627:therapeutic use*; D001026:Coronary Artery Bypass; D004311:Double-Blind Method; D017558:Elective Surgical Procedures; D005260:Female; D006801:Humans; D020925:Hypoxia-Ischemia, Brain / Q000517:prevention & control*; D007275:Injections, Intravenous; D007902:Length of Stay; D008297:Male; D009203:Myocardial Infarction / Q000517:prevention & control; D017202:Myocardial Ischemia / Q000517:prevention & control*; D009483:Neuropsychological Tests; D011183:Postoperative Complications; D011300:Preoperative Care; D011446:Prospective Studies
D000975:Antioxidants; D002316:Cardiotonic Agents