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

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

*Corresponding author for this work

Research output: Contribution to journalArticle

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Abstract

Objectives: We 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. Methods: We 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. Results: Among 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. Conclusions: Hemodilution 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.

Original languageEnglish (US)
JournalJournal of Thoracic and Cardiovascular Surgery
Volume135
Issue number2
DOIs
StatePublished - Jan 1 2008

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Cardiopulmonary Bypass
Hematocrit
Thoracic Surgery
Hemodilution
Hemodynamics
Transposition of Great Vessels
Water-Electrolyte Balance
Thoracic Aorta
Population
Length of Stay
Magnetic Resonance Imaging
Oxygen
Brain
Therapeutics

ASJC Scopus subject areas

  • Surgery
  • Pulmonary and Respiratory Medicine
  • Cardiology and Cardiovascular Medicine

Cite this

Newburger, Jane W. ; Jonas, Richard A. ; Soul, Janet ; Kussman, Barry D. ; Bellinger, David C. ; Laussen, Peter C. ; Robertson, Richard ; Mayer, John E. ; del Nido, Pedro J. ; Bacha, Emile A. ; Forbess, Joseph M. ; Pigula, Frank ; Roth, Stephen J. ; Visconti, Karen J. ; du Plessis, Adre J. ; Farrell, David M. ; McGrath, Ellen ; Rappaport, Leonard A. ; Wypij, David. / Randomized trial of hematocrit 25% versus 35% during hypothermic cardiopulmonary bypass in infant heart surgery. In: Journal of Thoracic and Cardiovascular Surgery. 2008 ; Vol. 135, No. 2.
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abstract = "Objectives: We 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. Methods: We 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. Results: Among 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. Conclusions: Hemodilution 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.",
author = "Newburger, {Jane W.} and Jonas, {Richard A.} and Janet Soul and Kussman, {Barry D.} and Bellinger, {David C.} and Laussen, {Peter C.} and Richard Robertson and Mayer, {John E.} and {del Nido}, {Pedro J.} and Bacha, {Emile A.} and Forbess, {Joseph M.} and Frank Pigula and Roth, {Stephen J.} and Visconti, {Karen J.} and {du Plessis}, {Adre J.} and Farrell, {David M.} and Ellen McGrath and Rappaport, {Leonard A.} and David Wypij",
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Newburger, JW, Jonas, RA, Soul, J, Kussman, BD, Bellinger, DC, Laussen, PC, Robertson, R, Mayer, JE, del Nido, PJ, Bacha, EA, Forbess, JM, Pigula, F, Roth, SJ, Visconti, KJ, du Plessis, AJ, Farrell, DM, McGrath, E, Rappaport, LA & Wypij, D 2008, 'Randomized trial of hematocrit 25% versus 35% during hypothermic cardiopulmonary bypass in infant heart surgery', Journal of Thoracic and Cardiovascular Surgery, vol. 135, no. 2. https://doi.org/10.1016/j.jtcvs.2007.01.051

Randomized trial of hematocrit 25% versus 35% during hypothermic cardiopulmonary bypass in infant heart surgery. / Newburger, Jane W.; Jonas, Richard A.; Soul, Janet; Kussman, Barry D.; Bellinger, David C.; Laussen, Peter C.; Robertson, Richard; Mayer, John E.; del Nido, Pedro J.; Bacha, Emile A.; Forbess, Joseph M.; Pigula, Frank; Roth, Stephen J.; Visconti, Karen J.; du Plessis, Adre J.; Farrell, David M.; McGrath, Ellen; Rappaport, Leonard A.; Wypij, David.

In: Journal of Thoracic and Cardiovascular Surgery, Vol. 135, No. 2, 01.01.2008.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Randomized trial of hematocrit 25% versus 35% during hypothermic cardiopulmonary bypass in infant heart surgery

AU - Newburger, Jane W.

AU - Jonas, Richard A.

AU - Soul, Janet

AU - Kussman, Barry D.

AU - Bellinger, David C.

AU - Laussen, Peter C.

AU - Robertson, Richard

AU - Mayer, John E.

AU - del Nido, Pedro J.

AU - Bacha, Emile A.

AU - Forbess, Joseph M.

AU - Pigula, Frank

AU - Roth, Stephen J.

AU - Visconti, Karen J.

AU - du Plessis, Adre J.

AU - Farrell, David M.

AU - McGrath, Ellen

AU - Rappaport, Leonard A.

AU - Wypij, David

PY - 2008/1/1

Y1 - 2008/1/1

N2 - Objectives: We 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. Methods: We 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. Results: Among 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. Conclusions: Hemodilution 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.

AB - Objectives: We 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. Methods: We 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. Results: Among 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. Conclusions: Hemodilution 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.

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