title: Aprotinin and perioperative complications in cardiac surgery.
abstract: OBJECTIVE
  Recently, the clinical significance of aprotinin-induced renal dysfunction and other end-organ complications in patients undergoing cardiac surgery has engendered substantial controversy. Therefore, we assessed the effect of aprotinin on end-organ complications in patients undergoing cardiac surgery.
  
  
  METHODS
  Data of 674 patients (mean age 65.4 +/- 11.0 years, 457 males) undergoing cardiac surgery between January 1 and December 31, 2005 at Semmelweis University were used for the analyses. Preoperative, intraoperative and postoperative clinical and surgical variables were recorded. Patients administered aprotinin received the drug either as a low-dose regimen, a loading dose of 1 million kallikrein-inhibitor units (KIU), 1 million KIU in pump, and 1 million KIU post pump (or continuous infusion of 0.25 million KIU per hour); or a high-dose regimen, a loading dose of 2 million KIU, 2 million KIU in pump, and 2 million KIU post pump (or continuous infusion of 0.5 million KIU per hour). The outcomes were renal complications defined as a 25% reduction in postoperative calculated creatinine clearance compared to the preoperative baseline or renal failure requiring dialysis; and the composite of renal, cardiovascular and cerebrovascular complications and all-cause mortality.
  
  
  RESULTS
  Patients underwent coronary artery bypass surgery (63%), valvular (27%) or a combination (5%) and surgery on the ascending aorta (5%). There were 550 patients (81.6%) who received aprotinin treatment. In multivariate regression analyses when the relation between high or low dose aprotinin compared to no aprotinin was evaluated, the likelihood of renal complications [high dose: odds ratio (OR)=1.4, 95% confidence interval (CI), 0.6-3.0, P=0.4; low dose: OR=1.2, 95%CI, 0.7-2.3, p=0.5], and the composite outcome variable (high dose: OR=1.6, 95%CI, 0.8-3.4, P=0.2; low dose: OR=1.3, 95%CI, 0.7-2.3, P=0.4) were not significantly increased.
  
  
  CONCLUSIONS
  Our analysis suggests that aprotinin use in either a high or low dose regimen was not associated with an increase in adverse end-organ complications.
authors.affiliation: Department of Cardiovascular Surgery, Semmelweis University, Budapest, Hungary. mkertai@hotmail.com
authors.forename: M D
authors.initials: MD
authors.lastname: Kertai
authors.forename: K S
authors.initials: KS
authors.lastname: Varga
authors.forename: D
authors.initials: D
authors.lastname: Royston
authors.forename: M J
authors.initials: MJ
authors.lastname: London
authors.forename: Z
authors.initials: Z
authors.lastname: Szabolcs
authors.forename: C R
authors.initials: CR
authors.lastname: Grebenik
authors.forename: G
authors.initials: G
authors.lastname: Acsady
authors.forename: J
authors.initials: J
authors.lastname: Gal
mesh_terms: D058186:Acute Kidney Injury / Q000139:chemically induced*; D000368:Aged; D007611:Aprotinin / Q000008:administration & dosage / Q000009:adverse effects*; D006348:Cardiac Surgical Procedures; D016009:Chi-Square Distribution; D004305:Dose-Response Relationship, Drug; D005260:Female; D006801:Humans; D007431:Intraoperative Complications / Q000139:chemically induced*; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D012307:Risk Factors; D015842:Serine Proteinase Inhibitors / Q000008:administration & dosage / Q000009:adverse effects*; D016896:Treatment Outcome
chemical_list: D015842:Serine Proteinase Inhibitors; D007611:Aprotinin