Abstract
BackgroundDuring 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.ObjectiveThe 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.MethodsThis 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.ResultsA 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.ConclusionsWe 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 RegistrationISRCTN Registry: ISRCTN93129502, http://www.isrctn.com/ISRCTN93129502 (Archived by WebCitation at http://www.webcitation.org/6Yf5VSyyG).
Highlights
BackgroundThe treatment of many forms of congenital heart disease has continued to advance, and primary early repairs of an increasing number of defects are routinely performed
JMIR Res Protoc 2015 | vol 4 | iss. 2 | e59 | p.1 to improve strategies of cardiopulmonary bypass perfusion and decrease the inevitable organ damage that occurs during nonphysiological body perfusion
Perfusion of the body and the brain at normal body temperature is a potentially more physiological method to maintain the functional integrity of major organ systems, and in recent years there has been an increasing interest in normothermic cardiopulmonary bypass (CPB) in adult and pediatric cardiac surgery [2-9]
Summary
BackgroundThe treatment of many forms of congenital heart disease has continued to advance, and primary early repairs of an increasing number of defects are routinely performed (eg, atrioventricular canal, tetralogy of Fallot, transposition of the great arteries). Perfusion of the body and the brain at normal body temperature (ie, normothermia) is a potentially more physiological method to maintain the functional integrity of major organ systems, and in recent years there has been an increasing interest in normothermic CPB in adult and pediatric cardiac surgery [2-9]. The concept that normothermic systemic perfusion may confer certain advantages over hypothermic regimes arose fortuitously from adult clinical experience in which an absence of shivering, hemodynamic stability, minimum use of inotropes, and early extubation were observed when patients were not cooled [2]. This led several investigators to study the effects of systemic hypothermia and normothermic perfusion upon cellular and organ function [2,10-14]. The two techniques have not been extensively compared in children
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