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Randomized trial of hematocrit 25% versus 35% during hypothermic cardiopulmonary bypass in infant heart surgery

2008; Elsevier BV; Volume: 135; Issue: 2 Linguagem: Inglês

10.1016/j.jtcvs.2007.01.051

1097-685X

Jane W. Newburger, Richard A. Jonas, Janet S. Soul, Barry D. Kussman, David C. Bellinger, Peter C. Laussen, Richard L. Robertson, John E. Mayer, Pedro J. del Nido, Emile Bacha, Joseph M. Forbess, Frank A. Pigula, Stephen J. Roth, Karen J. Visconti, Adré J. du Plessis, David M. Farrell, Ellen McGrath, Leonard Rappaport, David Wypij,

Neonatal and fetal brain pathology

ObjectivesWe previously reported that postoperative hemodynamics and developmental outcomes were better among infants randomized to a higher hematocrit value during hypothermic cardiopulmonary bypass. However, worse outcomes were concentrated in patients with hematocrit values of 20% or below, and the benefits of hematocrit values higher than 25% were uncertain.MethodsWe compared perioperative hemodynamics and, at 1 year, developmental outcome and brain magnetic resonance imaging in a single-center, randomized trial of hemodilution to a hematocrit value of 25% versus 35% during hypothermic radiopulmonary bypass for reparative heart surgery in infants undergoing 2-ventricle repairs without aortic arch obstruction.ResultsAmong 124 subjects, 56 were assigned to the lower-hematocrit strategy (24.8% ± 3.1%, mean ± SD) and 68 to the higher-hematocrit strategy (32.6% ± 3.5%). Infants randomized to the 25% strategy, compared with the 35% strategy, had a more positive intraoperative fluid balance (P = .007) and lower regional cerebral oxygen saturation at 10 minutes after cooling (P = .04) and onset of low flow (P = .03). Infants with dextro-transposition of the great arteries in the 25% group had significantly longer hospital stay. Other postoperative outcomes, blood product usage, and adverse events were similar in the treatment groups. At age 1 year (n = 106), the treatment groups had similar scores on the Psychomotor and Mental Development Indexes of the Bayley Scales; both groups scored significantly worse than population norms.ConclusionsHemodilution to hematocrit levels of 35% compared with those of 25% had no major benefits or risks overall among infants undergoing 2-ventricle repair. Developmental outcomes at age 1 year in both randomized groups were below those in the normative population.