| Randomized trial of hematocrit 25% versus 35% during hypothermic cardiopulmonary bypass in infant heart surgery. | |
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MedLine Citation:
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PMID: 18242267 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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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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Authors:
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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 |
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Publication Detail:
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Type: Journal Article; Randomized Controlled Trial; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't |
Journal Detail:
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Title: The Journal of thoracic and cardiovascular surgery Volume: 135 ISSN: 1097-685X ISO Abbreviation: J. Thorac. Cardiovasc. Surg. Publication Date: 2008 Feb |
Date Detail:
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Created Date: 2008-02-04 Completed Date: 2008-03-10 Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 0376343 Medline TA: J Thorac Cardiovasc Surg Country: United States |
Other Details:
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Languages: eng Pagination: 347-54, 354.e1-4 Citation Subset: AIM; IM |
Affiliation:
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Department of Cardiology, Children's Hospital Boston, Boston, Mass 02115, USA. jane.newburger@cardio.chboston.org |
| Data Bank Information | |
Bank Name/Acc. No.:
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ClinicalTrials.gov/NCT00006183 |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Cardiac Surgical Procedures
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adverse effects,
methods Cardiopulmonary Bypass / adverse effects, methods* Cause of Death Central Nervous System Diseases / epidemiology, etiology Developmental Disabilities / epidemiology, etiology, prevention & control* Female Follow-Up Studies Heart Defects, Congenital / diagnosis, mortality*, surgery* Heart Septal Defects, Ventricular / diagnosis, mortality, surgery Hematocrit* Hemodilution / adverse effects* Humans Hypothermia, Induced* Incidence Infant Male Postoperative Complications / epidemiology Probability Risk Assessment Survival Analysis Tetralogy of Fallot / diagnosis, mortality, surgery Time Factors Transposition of Great Vessels / diagnosis, mortality, surgery Treatment Outcome |
| Grant Support | |
ID/Acronym/Agency:
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HL 063411/HL/NHLBI NIH HHS; RR 02172/RR/NCRR NIH HHS |
| Comments/Corrections | |
Comment In:
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J Thorac Cardiovasc Surg. 2008 Feb;135(2):240-2, 242.e1-2
[PMID:
18242241
]
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From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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