The influence of hemodilution on outcome after hypothermic cardiopulmonary bypass: Results of a randomized trial in infants

Richard A. Jonas, David Wypij, Stephen J. Roth, David C. Bellinger, Karen J. Visconti, Adre J. Du Plessis, Howard Goodkin, Peter C. Laussen, David M. Farrell, Jodi Bartlett, Ellen McGrath, Leonard J. Rappaport, Emile A. Bacha, Joseph M. Forbess, Pedro J. Del Nido, John E. Mayer, Jane W. Newburger, William A Baumgartner, Vaughn A. Starnes, Charles D. FraserSoon J. Park

Research output: Contribution to journalArticle

Abstract

Background: We hypothesized that cognitive impairment and hemodynamic instability after infant cardiac surgery with cardiopulmonary bypass might be exacerbated by hemodilution. Methods: In a single-center randomized trial with blinded assessment of outcomes, we compared use of 2 hemodilution protocols during hypothermic cardiopulmonary bypass with infant cardiac surgery. The primary perioperative end point was lowest cardiac index in the first 24 hours postoperatively, and primary end points at age 1 year were scores on the Psychomotor Development Index and Mental Developmental Index of the Bayley Scales. Results: Among 147 subjects, 74 were assigned to the lower-hematocrit strategy (21.5% ± 2.9%, mean ± SD at onset of low-flow bypass) and 73 to the higher-hematocrit strategy (27.8% ± 3.2%). In intent-to-treat analyses the lower-hematocrit group had lower nadirs of cardiac index (P =.02), higher serum lactate levels 60 minutes after cardiopulmonary bypass (P =.03), and a greater percentage increase in total body water on the first postoperative day (P = .006). Blood product use and adverse events were similar in the 2 groups. At age 1 year (113 children), the lower-hematocrit group had worse scores on the Psychomotor Development Index (81.9 ± 15.7 vs 89.7 ± 14.7, P = .008), as well as more Psychomotor Development Index scores at least 2 SDs below the population mean (16/56 [29%] vs 5/53 [9%], P = .01). The groups had similar Mental Developmental Index scores and findings on neurologic examination. Inferences using hematocrit as a continuous variable were similar to those based on intent-to-treat analyses. Conclusions: Hemodilution to a hematocrit level in wide use for cardiopulmonary bypass and thought to be safe is associated with adverse perioperative and developmental outcomes in infants.

Original languageEnglish (US)
Pages (from-to)1765-1774
Number of pages10
JournalJournal of Thoracic and Cardiovascular Surgery
Volume126
Issue number6
DOIs
StatePublished - Dec 2003
Externally publishedYes

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Hemodilution
Cardiopulmonary Bypass
Hematocrit
Thoracic Surgery
Body Water
Neurologic Examination
Lactic Acid
Hemodynamics
Outcome Assessment (Health Care)
Serum
Population

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine
  • Surgery

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The influence of hemodilution on outcome after hypothermic cardiopulmonary bypass : Results of a randomized trial in infants. / Jonas, Richard A.; Wypij, David; Roth, Stephen J.; Bellinger, David C.; Visconti, Karen J.; Du Plessis, Adre J.; Goodkin, Howard; Laussen, Peter C.; Farrell, David M.; Bartlett, Jodi; McGrath, Ellen; Rappaport, Leonard J.; Bacha, Emile A.; Forbess, Joseph M.; Del Nido, Pedro J.; Mayer, John E.; Newburger, Jane W.; Baumgartner, William A; Starnes, Vaughn A.; Fraser, Charles D.; Park, Soon J.

In: Journal of Thoracic and Cardiovascular Surgery, Vol. 126, No. 6, 12.2003, p. 1765-1774.

Research output: Contribution to journalArticle

Jonas, RA, Wypij, D, Roth, SJ, Bellinger, DC, Visconti, KJ, Du Plessis, AJ, Goodkin, H, Laussen, PC, Farrell, DM, Bartlett, J, McGrath, E, Rappaport, LJ, Bacha, EA, Forbess, JM, Del Nido, PJ, Mayer, JE, Newburger, JW, Baumgartner, WA, Starnes, VA, Fraser, CD & Park, SJ 2003, 'The influence of hemodilution on outcome after hypothermic cardiopulmonary bypass: Results of a randomized trial in infants', Journal of Thoracic and Cardiovascular Surgery, vol. 126, no. 6, pp. 1765-1774. https://doi.org/10.1016/j.jtcvs.2003.04.003
Jonas, Richard A. ; Wypij, David ; Roth, Stephen J. ; Bellinger, David C. ; Visconti, Karen J. ; Du Plessis, Adre J. ; Goodkin, Howard ; Laussen, Peter C. ; Farrell, David M. ; Bartlett, Jodi ; McGrath, Ellen ; Rappaport, Leonard J. ; Bacha, Emile A. ; Forbess, Joseph M. ; Del Nido, Pedro J. ; Mayer, John E. ; Newburger, Jane W. ; Baumgartner, William A ; Starnes, Vaughn A. ; Fraser, Charles D. ; Park, Soon J. / The influence of hemodilution on outcome after hypothermic cardiopulmonary bypass : Results of a randomized trial in infants. In: Journal of Thoracic and Cardiovascular Surgery. 2003 ; Vol. 126, No. 6. pp. 1765-1774.
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abstract = "Background: We hypothesized that cognitive impairment and hemodynamic instability after infant cardiac surgery with cardiopulmonary bypass might be exacerbated by hemodilution. Methods: In a single-center randomized trial with blinded assessment of outcomes, we compared use of 2 hemodilution protocols during hypothermic cardiopulmonary bypass with infant cardiac surgery. The primary perioperative end point was lowest cardiac index in the first 24 hours postoperatively, and primary end points at age 1 year were scores on the Psychomotor Development Index and Mental Developmental Index of the Bayley Scales. Results: Among 147 subjects, 74 were assigned to the lower-hematocrit strategy (21.5{\%} ± 2.9{\%}, mean ± SD at onset of low-flow bypass) and 73 to the higher-hematocrit strategy (27.8{\%} ± 3.2{\%}). In intent-to-treat analyses the lower-hematocrit group had lower nadirs of cardiac index (P =.02), higher serum lactate levels 60 minutes after cardiopulmonary bypass (P =.03), and a greater percentage increase in total body water on the first postoperative day (P = .006). Blood product use and adverse events were similar in the 2 groups. At age 1 year (113 children), the lower-hematocrit group had worse scores on the Psychomotor Development Index (81.9 ± 15.7 vs 89.7 ± 14.7, P = .008), as well as more Psychomotor Development Index scores at least 2 SDs below the population mean (16/56 [29{\%}] vs 5/53 [9{\%}], P = .01). The groups had similar Mental Developmental Index scores and findings on neurologic examination. Inferences using hematocrit as a continuous variable were similar to those based on intent-to-treat analyses. Conclusions: Hemodilution to a hematocrit level in wide use for cardiopulmonary bypass and thought to be safe is associated with adverse perioperative and developmental outcomes in infants.",
author = "Jonas, {Richard A.} and David Wypij and Roth, {Stephen J.} and Bellinger, {David C.} and Visconti, {Karen J.} and {Du Plessis}, {Adre J.} and Howard Goodkin and Laussen, {Peter C.} and Farrell, {David M.} and Jodi Bartlett and Ellen McGrath and Rappaport, {Leonard J.} and Bacha, {Emile A.} and Forbess, {Joseph M.} and {Del Nido}, {Pedro J.} and Mayer, {John E.} and Newburger, {Jane W.} and Baumgartner, {William A} and Starnes, {Vaughn A.} and Fraser, {Charles D.} and Park, {Soon J.}",
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T1 - The influence of hemodilution on outcome after hypothermic cardiopulmonary bypass

T2 - Results of a randomized trial in infants

AU - Jonas, Richard A.

AU - Wypij, David

AU - Roth, Stephen J.

AU - Bellinger, David C.

AU - Visconti, Karen J.

AU - Du Plessis, Adre J.

AU - Goodkin, Howard

AU - Laussen, Peter C.

AU - Farrell, David M.

AU - Bartlett, Jodi

AU - McGrath, Ellen

AU - Rappaport, Leonard J.

AU - Bacha, Emile A.

AU - Forbess, Joseph M.

AU - Del Nido, Pedro J.

AU - Mayer, John E.

AU - Newburger, Jane W.

AU - Baumgartner, William A

AU - Starnes, Vaughn A.

AU - Fraser, Charles D.

AU - Park, Soon J.

PY - 2003/12

Y1 - 2003/12

N2 - Background: We hypothesized that cognitive impairment and hemodynamic instability after infant cardiac surgery with cardiopulmonary bypass might be exacerbated by hemodilution. Methods: In a single-center randomized trial with blinded assessment of outcomes, we compared use of 2 hemodilution protocols during hypothermic cardiopulmonary bypass with infant cardiac surgery. The primary perioperative end point was lowest cardiac index in the first 24 hours postoperatively, and primary end points at age 1 year were scores on the Psychomotor Development Index and Mental Developmental Index of the Bayley Scales. Results: Among 147 subjects, 74 were assigned to the lower-hematocrit strategy (21.5% ± 2.9%, mean ± SD at onset of low-flow bypass) and 73 to the higher-hematocrit strategy (27.8% ± 3.2%). In intent-to-treat analyses the lower-hematocrit group had lower nadirs of cardiac index (P =.02), higher serum lactate levels 60 minutes after cardiopulmonary bypass (P =.03), and a greater percentage increase in total body water on the first postoperative day (P = .006). Blood product use and adverse events were similar in the 2 groups. At age 1 year (113 children), the lower-hematocrit group had worse scores on the Psychomotor Development Index (81.9 ± 15.7 vs 89.7 ± 14.7, P = .008), as well as more Psychomotor Development Index scores at least 2 SDs below the population mean (16/56 [29%] vs 5/53 [9%], P = .01). The groups had similar Mental Developmental Index scores and findings on neurologic examination. Inferences using hematocrit as a continuous variable were similar to those based on intent-to-treat analyses. Conclusions: Hemodilution to a hematocrit level in wide use for cardiopulmonary bypass and thought to be safe is associated with adverse perioperative and developmental outcomes in infants.

AB - Background: We hypothesized that cognitive impairment and hemodynamic instability after infant cardiac surgery with cardiopulmonary bypass might be exacerbated by hemodilution. Methods: In a single-center randomized trial with blinded assessment of outcomes, we compared use of 2 hemodilution protocols during hypothermic cardiopulmonary bypass with infant cardiac surgery. The primary perioperative end point was lowest cardiac index in the first 24 hours postoperatively, and primary end points at age 1 year were scores on the Psychomotor Development Index and Mental Developmental Index of the Bayley Scales. Results: Among 147 subjects, 74 were assigned to the lower-hematocrit strategy (21.5% ± 2.9%, mean ± SD at onset of low-flow bypass) and 73 to the higher-hematocrit strategy (27.8% ± 3.2%). In intent-to-treat analyses the lower-hematocrit group had lower nadirs of cardiac index (P =.02), higher serum lactate levels 60 minutes after cardiopulmonary bypass (P =.03), and a greater percentage increase in total body water on the first postoperative day (P = .006). Blood product use and adverse events were similar in the 2 groups. At age 1 year (113 children), the lower-hematocrit group had worse scores on the Psychomotor Development Index (81.9 ± 15.7 vs 89.7 ± 14.7, P = .008), as well as more Psychomotor Development Index scores at least 2 SDs below the population mean (16/56 [29%] vs 5/53 [9%], P = .01). The groups had similar Mental Developmental Index scores and findings on neurologic examination. Inferences using hematocrit as a continuous variable were similar to those based on intent-to-treat analyses. Conclusions: Hemodilution to a hematocrit level in wide use for cardiopulmonary bypass and thought to be safe is associated with adverse perioperative and developmental outcomes in infants.

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