title: Aprotinin is safe in pediatric patients undergoing cardiac surgery.
abstract: OBJECTIVE
  Aprotinin, a serine protease inhibitor, decreases transfusion requirements and inflammatory response after cardiopulmonary bypass. This study was done to determine whether aprotinin is associated with adverse outcomes, particularly mortality and acute kidney failure, in pediatric patients (<18 years of age) undergoing cardiopulmonary bypass.
  
  
  METHODS
  We compared a cohort of all pediatric cardiopulmonary bypass operations from 1994-1999, when aprotinin was not used (n = 1230), with a cohort from 2000-2006, when all patients received high-dose aprotinin (n = 1251). Primary end points were operative and late mortality, acute kidney failure, need for dialysis, and neurologic complications. Association of aprotinin with primary end points was assessed by means of univariate analysis, multivariate logistic regression, and Cox regression analysis, where appropriate.
  
  
  RESULTS
  The aprotinin group was younger (mean age, 3.49 +/- 1.84 vs 3.64 +/- 4.75 years; P = .019) and had a higher Aristotle score (7.8 +/- 2.3 vs 7.2 +/- 2.6, P < .001). Univariate and multivariate analysis showed no significant difference between the no-aprotinin and aprotinin groups for operative mortality (55 [4.5%] vs 47 [3.8%], P = .508), acute kidney failure (68 [6.0%] vs 69 [5.7%], P = .77), need for temporary dialysis (6 [0.49%] vs 12 [0.96%], P = .17), or neurologic complications (14 [1.1%] vs 17 [1.4%], P = .62). By means of Cox regression analysis, aprotinin had no influence on late mortality (24 vs 10 deaths, P = .078).
  
  
  CONCLUSIONS
  In this retrospective cohort study of pediatric patients undergoing cardiopulmonary bypass, there was no association between the use of aprotinin and acute kidney failure, need for dialysis, neurologic complications, and operative or late mortality. We continue to use aprotinin for all pediatric patients undergoing cardiopulmonary bypass.
authors.affiliation: Division of Cardiovascular-Thoracic Surgery, Department of Surgery, Northwestern University Feinberg School of Medicine, Chicago, Ill, USA.
authors.forename: Carl L
authors.initials: CL
authors.lastname: Backer
authors.forename: Angela M
authors.initials: AM
authors.lastname: Kelle
authors.forename: Robert D
authors.initials: RD
authors.lastname: Stewart
authors.forename: Sunitha C
authors.initials: SC
authors.lastname: Suresh
authors.forename: Farah N
authors.initials: FN
authors.lastname: Ali
authors.forename: Richard A
authors.initials: RA
authors.lastname: Cohn
authors.forename: Roopa
authors.initials: R
authors.lastname: Seshadri
authors.forename: Constantine
authors.initials: C
authors.lastname: Mavroudis
mesh_terms: D058186:Acute Kidney Injury / Q000139:chemically induced / Q000209:etiology / Q000628:therapy; D007611:Aprotinin / Q000009:adverse effects / Q000627:therapeutic use*; D006348:Cardiac Surgical Procedures; D002315:Cardiopulmonary Bypass / Q000401:mortality; D002648:Child; D002675:Child, Preschool; D015331:Cohort Studies; D005260:Female; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D008297:Male; D009422:Nervous System Diseases / Q000139:chemically induced / Q000209:etiology; D011183:Postoperative Complications; D016016:Proportional Hazards Models; D006435:Renal Dialysis; D012189:Retrospective Studies; D015842:Serine Proteinase Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D015842:Serine Proteinase Inhibitors; D007611:Aprotinin