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Normothermic Versus Hypothermic Cardiopulmonary Bypass in Children Undergoing Open Heart Surgery (Thermic-2): Study Protocol for a Randomized Controlled Trial

BACKGROUND: During open heart surgery, patients are connected to a heart-lung bypass machine that pumps blood around the body (“perfusion”) while the heart is stopped. Typically the blood is cooled during this procedure (“hypothermia”) and warmed to normal body temperature once the operation has bee...

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Autores principales: Baos, Sarah, Sheehan, Karen, Culliford, Lucy, Pike, Katie, Ellis, Lucy, Parry, Andrew J, Stoica, Serban, Ghorbel, Mohamed T, Caputo, Massimo, Rogers, Chris A
Formato: Online Artículo Texto
Lenguaje:English
Publicado: JMIR Publications Inc. 2015
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4460263/
https://www.ncbi.nlm.nih.gov/pubmed/26007621
http://dx.doi.org/10.2196/resprot.4338
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author Baos, Sarah
Sheehan, Karen
Culliford, Lucy
Pike, Katie
Ellis, Lucy
Parry, Andrew J
Stoica, Serban
Ghorbel, Mohamed T
Caputo, Massimo
Rogers, Chris A
author_facet Baos, Sarah
Sheehan, Karen
Culliford, Lucy
Pike, Katie
Ellis, Lucy
Parry, Andrew J
Stoica, Serban
Ghorbel, Mohamed T
Caputo, Massimo
Rogers, Chris A
author_sort Baos, Sarah
collection PubMed
description BACKGROUND: During open heart surgery, patients are connected to a heart-lung bypass machine that pumps blood around the body (“perfusion”) while the heart is stopped. Typically the blood is cooled during this procedure (“hypothermia”) and warmed to normal body temperature once the operation has been completed. The main rationale for “whole body cooling” is to protect organs such as the brain, kidneys, lungs, and heart from injury during bypass by reducing the body’s metabolic rate and decreasing oxygen consumption. However, hypothermic perfusion also has disadvantages that can contribute toward an extended postoperative hospital stay. Research in adults and small randomized controlled trials in children suggest some benefits to keeping the blood at normal body temperature throughout surgery (“normothermia”). However, the two techniques have not been extensively compared in children. OBJECTIVE: The Thermic-2 study will test the hypothesis that the whole body inflammatory response to the nonphysiological bypass and its detrimental effects on different organ functions may be attenuated by maintaining the body at 35°C-37°C (normothermic) rather than 28°C (hypothermic) during pediatric complex open heart surgery. METHODS: This is a single-center, randomized controlled trial comparing the effectiveness and acceptability of normothermic versus hypothermic bypass in 141 children with congenital heart disease undergoing open heart surgery. Children having scheduled surgery to repair a heart defect not requiring deep hypothermic circulatory arrest represent the target study population. The co-primary clinical outcomes are duration of inotropic support, intubation time, and postoperative hospital stay. Secondary outcomes are in-hospital mortality and morbidity, blood loss and transfusion requirements, pre- and post-operative echocardiographic findings, routine blood gas and blood test results, renal function, cerebral function, regional oxygen saturation of blood in the cerebral cortex, assessment of genomic expression changes in cardiac tissue biopsies, and neuropsychological development. RESULTS: A total of 141 patients have been successfully randomized over 2 years and 10 months and are now being followed-up for 1 year. Results will be published in 2015. CONCLUSIONS: We believe this to be the first large pragmatic study comparing clinical outcomes during normothermic versus hypothermic bypass in complex open heart surgery in children. It is expected that this work will provide important information to improve strategies of cardiopulmonary bypass perfusion and therefore decrease the inevitable organ damage that occurs during nonphysiological body perfusion. TRIAL REGISTRATION: ISRCTN Registry: ISRCTN93129502, http://www.isrctn.com/ISRCTN93129502 (Archived by WebCitation at http://www.webcitation.org/6Yf5VSyyG).
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spelling pubmed-44602632015-06-19 Normothermic Versus Hypothermic Cardiopulmonary Bypass in Children Undergoing Open Heart Surgery (Thermic-2): Study Protocol for a Randomized Controlled Trial Baos, Sarah Sheehan, Karen Culliford, Lucy Pike, Katie Ellis, Lucy Parry, Andrew J Stoica, Serban Ghorbel, Mohamed T Caputo, Massimo Rogers, Chris A JMIR Res Protoc Protocol BACKGROUND: During open heart surgery, patients are connected to a heart-lung bypass machine that pumps blood around the body (“perfusion”) while the heart is stopped. Typically the blood is cooled during this procedure (“hypothermia”) and warmed to normal body temperature once the operation has been completed. The main rationale for “whole body cooling” is to protect organs such as the brain, kidneys, lungs, and heart from injury during bypass by reducing the body’s metabolic rate and decreasing oxygen consumption. However, hypothermic perfusion also has disadvantages that can contribute toward an extended postoperative hospital stay. Research in adults and small randomized controlled trials in children suggest some benefits to keeping the blood at normal body temperature throughout surgery (“normothermia”). However, the two techniques have not been extensively compared in children. OBJECTIVE: The Thermic-2 study will test the hypothesis that the whole body inflammatory response to the nonphysiological bypass and its detrimental effects on different organ functions may be attenuated by maintaining the body at 35°C-37°C (normothermic) rather than 28°C (hypothermic) during pediatric complex open heart surgery. METHODS: This is a single-center, randomized controlled trial comparing the effectiveness and acceptability of normothermic versus hypothermic bypass in 141 children with congenital heart disease undergoing open heart surgery. Children having scheduled surgery to repair a heart defect not requiring deep hypothermic circulatory arrest represent the target study population. The co-primary clinical outcomes are duration of inotropic support, intubation time, and postoperative hospital stay. Secondary outcomes are in-hospital mortality and morbidity, blood loss and transfusion requirements, pre- and post-operative echocardiographic findings, routine blood gas and blood test results, renal function, cerebral function, regional oxygen saturation of blood in the cerebral cortex, assessment of genomic expression changes in cardiac tissue biopsies, and neuropsychological development. RESULTS: A total of 141 patients have been successfully randomized over 2 years and 10 months and are now being followed-up for 1 year. Results will be published in 2015. CONCLUSIONS: We believe this to be the first large pragmatic study comparing clinical outcomes during normothermic versus hypothermic bypass in complex open heart surgery in children. It is expected that this work will provide important information to improve strategies of cardiopulmonary bypass perfusion and therefore decrease the inevitable organ damage that occurs during nonphysiological body perfusion. TRIAL REGISTRATION: ISRCTN Registry: ISRCTN93129502, http://www.isrctn.com/ISRCTN93129502 (Archived by WebCitation at http://www.webcitation.org/6Yf5VSyyG). JMIR Publications Inc. 2015-05-25 /pmc/articles/PMC4460263/ /pubmed/26007621 http://dx.doi.org/10.2196/resprot.4338 Text en ©Sarah Baos, Karen Sheehan, Lucy Culliford, Katie Pike, Lucy Ellis, Andrew J Parry, Serban Stoica, Mohamed T Ghorbel, Massimo Caputo, Chris A Rogers. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 25.05.2015. http://creativecommons.org/licenses/by/2.0/ This is an open-access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Research Protocols, is properly cited. The complete bibliographic information, a link to the original publication on http://www.researchprotocols.org, as well as this copyright and license information must be included.
spellingShingle Protocol
Baos, Sarah
Sheehan, Karen
Culliford, Lucy
Pike, Katie
Ellis, Lucy
Parry, Andrew J
Stoica, Serban
Ghorbel, Mohamed T
Caputo, Massimo
Rogers, Chris A
Normothermic Versus Hypothermic Cardiopulmonary Bypass in Children Undergoing Open Heart Surgery (Thermic-2): Study Protocol for a Randomized Controlled Trial
title Normothermic Versus Hypothermic Cardiopulmonary Bypass in Children Undergoing Open Heart Surgery (Thermic-2): Study Protocol for a Randomized Controlled Trial
title_full Normothermic Versus Hypothermic Cardiopulmonary Bypass in Children Undergoing Open Heart Surgery (Thermic-2): Study Protocol for a Randomized Controlled Trial
title_fullStr Normothermic Versus Hypothermic Cardiopulmonary Bypass in Children Undergoing Open Heart Surgery (Thermic-2): Study Protocol for a Randomized Controlled Trial
title_full_unstemmed Normothermic Versus Hypothermic Cardiopulmonary Bypass in Children Undergoing Open Heart Surgery (Thermic-2): Study Protocol for a Randomized Controlled Trial
title_short Normothermic Versus Hypothermic Cardiopulmonary Bypass in Children Undergoing Open Heart Surgery (Thermic-2): Study Protocol for a Randomized Controlled Trial
title_sort normothermic versus hypothermic cardiopulmonary bypass in children undergoing open heart surgery (thermic-2): study protocol for a randomized controlled trial
topic Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4460263/
https://www.ncbi.nlm.nih.gov/pubmed/26007621
http://dx.doi.org/10.2196/resprot.4338
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