The aim was to determine whether the administration of aprotinin can cause deleterious effects on renal function in cardiac surgery with cardiopulmonary bypass (CPB).
Sixty consecutive patients with normal preoperative renal function undergoing elective coronary artery bypass surgery with CPB using the same anaesthetic; CPB and surgical protocols were randomized into three groups. Patients received placebo (Group 1), low-dose aprotinin (Group 2) or high-dose aprotinin (Group 3). Renal parameters measured were plasma creatinine, alpha1-microglobulin and beta-glucosaminidase (beta-NAG) excretion. Measurements were performed before surgery, during CPB and 24 and 72 h, and 7 and 40 days postoperatively.
In the three groups, alpha1-microglobulin and beta-NAG excretions significantly increased during CPB, at 24 and 72 h, and 7 days postoperatively (P < 0.05) and had returned to preoperative levels at postoperative day 40. Plasma creatinine levels were within normal values at times recorded. In Groups 2 and 3, alpha1-microglobulin excretion during CPB was significantly higher than in Group 1 (P < 0.001), and 24h after surgery it still remained significantly higher in Group 3 compared to Groups 1 and 2 (P < 0.05).
Aprotinin caused a significant increase in alpha1-microglobulin excretion but not in beta-NAG excretion during CPB, which may be interpreted as a greater renal tubular overload without tubular damage. This effect persisted for 24 h after surgery when high-dose aprotinin doses had been administered. Creatinine plasma levels were not sensitive to detect these prolonged renal effects in our study.
[Show abstract][Hide abstract] ABSTRACT: Aprotinin is the only agent with Class A Level 1 evidence for reduction in rates of transfusion and return to operating theatre to control bleeding after heart surgery. Principal on the list of safety issues raised over the years are increased risk for: a) thrombosis; and b) renal dysfunction. With multiple administrations, hypersensitivity reactions have emerged as a further safety concern. This review discusses these issues, based on the examination of > 500 published articles. The article also specifically places in context the data presented recently from the observational McSPI database analysis. This report suggested that aprotinin should be withdrawn from human use as serious safety issues have been ignored or missed, an inference not in agreement with the majority of the human safety literature.
Expert Opinion on Drug Safety 07/2006; 5(4):539-52. DOI:10.1517/147403184.108.40.2069 · 2.91 Impact Factor
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