Comparison of high glucose concentration blood and crystalloid cardioplegia in paediatric cardiac surgery: a randomized clinical trial.
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SUBMITTER: Mimic B
PROVIDER: S-EPMC4892136 | biostudies-literature | 2016 May
REPOSITORIES: biostudies-literature
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Comparison of high glucose concentration blood and crystalloid cardioplegia in paediatric cardiac surgery: a randomized clinical trial.
Mimic Branko B Ilic Slobodan S Vulicevic Irena I Milovanovic Vladimir V Tomic Danijela D Mimic Ana A Stankovic Sanja S Zecevic Tatjana T Davies Ben B Djordjevic Miroslav M
Interactive cardiovascular and thoracic surgery 20160131 5
<h4>Objectives</h4>This study investigates the effects of high glucose content on patients undergoing cold crystalloid versus cold blood cardioplegia in terms of early clinical results, functional myocardial recovery and ischaemia-reperfusion injury in patients undergoing repair of acyanotic cardiac lesions.<h4>Methods</h4>Patients were randomly assigned to receive either crystalloid (n = 31) or blood cardioplegia (n = 31). Early clinical results were assessed. Changes in left ventricular fracti ...[more]
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Project description:BackgroundExperimental evidence suggests that blood cardioplegia (BCP) may be superior to cold crystalloid cardioplegia (CCP) for myocardial protection. However, robust clinical data are lacking. We compared postoperative outcome of patients undergoing aortic valve replacement (AVR) using cold anterograde-retrograde intermittent BCP versus anterograde (CCP).MethodsAdult consecutive isolated AVR performed between April 2006 and February 2011 at the Royal Infirmary Hospital of Edinburgh were retrospectively analyzed. The use of anterograde CCP was compared with that of intermittent anterograde-retrograde cold BCP. End points were intra-operative mortality, 30-day hospital re-admission, need for RBC or platelet transfusion, mechanical ventilation time and renal failure.ResultsOf total 774 cases analyzed, 592 cases of BCP and 182 cases of CCP were identified. Demographics did not differ between groups (mean age: 67±12 years in CCP and 69±12 years in BCP). Groups (BCP vs. CCP) were indistinguishable (P>0.05, not significant) based on: average aortic cross clamp time 77.01±14.47 vs. 75.78±18.78 minutes, cardiopulmonary bypass time 104.07±43.70 vs. 100.34±25.90 minutes, surgery time 190.53±61.80 vs. 204.04±51.09 minutes and postoperative total blood consumption 1.38±2.11 vs. 1.61±2.4 units. The percentage of patients who required platelets' transfusion was similar: 12.8% BCP and 18.7% CCP (Fisher's exact test, P=0.053). Prevalence of respiratory failure was lower in BCP than in CCP: 2.6% vs. 6.3% (P=0.028). Admission time (days) at ICU was 3.63± 21.90 in BCP and 3.07±8.04 in CCP (not significant). Intra-hospital mortality, 30-day hospital re-admission, renal failure, sepsis, wound healing and stroke did not differ between groups.ConclusionsBCP was strictly not superior to CCP in every aspect. In particular it was definitely not superior in terms of postoperative ventricular function. Our results question the absolute superiority of BCP over CCP in terms of hard outcomes. Likelihood of serious complications should be considered to improve risk profile of patients before choosing a cardioplegic solution.
| S-EPMC7099971 | biostudies-literature
Project description:ObjectivesCardioplegia is the primary method for myocardial protection during cardiac surgery. We conducted a systematic review of randomized controlled trials of cardioplegia in children to evaluate the current evidence base.MethodsWe searched MEDLINE, CENTRAL and LILACS and manually screened retrieved references and systematic reviews to identify all randomized controlled trials comparing cardioplegia solutions or additives in children undergoing cardiac surgery published in any language; secondary publications and those reporting inseparable adult data were excluded. Two or more reviewers independently screened studies for eligibility and extracted data; the Cochrane Risk of Bias tool was used to assess for potential biases.ResultsWe identified 26 trials randomizing 1596 children undergoing surgery; all were single-centre, Phase II trials, recruiting few patients (median 48, interquartile range 30-99). The most frequent comparison was blood versus crystalloid in 10 (38.5%) trials, and the most common end points were biomarkers of myocardial injury (17, 65.4%), inotrope requirements (15, 57.7%) and length of stay in the intensive care unit (11, 42.3%). However, the heterogeneity of patients, interventions and reported outcome measures prohibited meta-analysis. Overall risk of bias was high in 3 (11.5%) trials, unclear in 23 (88.5%) and low in none.ConclusionsThe current literature on cardioplegia in children contains no late phase trials. The small size, inconsistent use of end points and low quality of reported trials provide a limited evidence base to inform practice. A core outcome set of clinically important, standardized, validated end points for assessing myocardial protection in children should be developed to facilitate the conduct of high-quality, multicentre trials.Prospero registrationCRD42017080205.
| S-EPMC6328004 | biostudies-literature
Project description:INTRODUCTION:Many techniques are available for cardioplegic arrest in children, but there is a lack of late phase clinical trials to guide practice. We surveyed paediatric cardiac surgeons and perfusionists to establish current practice and willingness to change within a clinical trial. METHODS:An online survey was sent to all consultant paediatric cardiac surgeons and chief perfusionists in paediatric centres in the UK and Ireland. Information was sought on cardioplegia type, composition, temperature, topical cooling, dosing for induction and maintenance, interval between doses, whether practice changed with patient age or complexity and whether respondents would be willing and able to use different cardioplegia solutions within a randomised trial. RESULTS:Responses were obtained from 32 (78.0%) surgeons and 12 (100%) perfusionists. Twenty-seven (84.4%) surgeons use blood cardioplegia in infants, with St. Thomas' Harefield preparation the most popular (19, 59.4%), used routinely in eight (66.7%) centres. Twenty-two (68.8%) administer at 4-6°C, 18 (56.3%) use topical cooling, 18 (56.3%) give 30 ml/kg induction and 15 ml/kg maintenance, with 23 (71.9%) re-dosing every 20-25 minutes. Thirty (93.8%) surgeons were open to randomising patients in a trial, with del Nido (29, 90.6%) the most popular. CONCLUSIONS:This survey demonstrates heterogeneity in cardioplegia practice. Whilst most surgeons use blood cardioplegia, there is variation in type, temperature, topical cooling, dosing and intervals. Combined with a lack of evidence from late phase trials, our findings support the presence of clinical equipoise. Surgeons are willing to change practice, suggesting that a pragmatic, multi-centre, randomised, controlled trial of cardioplegia in children is feasible.
| S-EPMC6378396 | biostudies-literature
Project description:BACKGROUND:The use of cardioplegia solutions as a myocardial protection technique is essential during cardiac surgery with cardiopulmonary bypass. The del Nido cardioplegia solution (DNS) has been widely used as a myocardial preservation technique for pediatric patients undergoing cardiac surgery with cardiopulmonary bypass. Its unique pharmacological features have created growing interest for adult cardiac surgery, especially for elderly patients or those with ventricular dysfunction who are more prone to ischemia-reperfusion injury. Ever since its implementation, several retrospective studies have been published to validate the efficacy, safety, and efficiency of DNS in adult patients undergoing coronary revascularization, valve replacement, or combined procedures. Recently, a meta-analysis based on nine retrospective studies was published claiming the noninferiority of DNS compared to other conventional cardioplegia solutions. Few prospective randomized studies have been conducted whose primary outcome was the assessment of DNS clinical efficacy compared to other solutions commonly used in adult patients. OBJECTIVE:The aim of this randomized clinical trial is to assess the benefits of DNS compared to Cardi-Braun blood cardioplegia solution in clinical and biochemical terms regarding myocardial protection during adult cardiac surgery. METHODS:This is the protocol of a controlled, randomized, single-center clinical trial carried out at the Puerta de Hierro Majadahonda University Hospital in Spain. A total of 474 participants over the age of 18 years undergoing elective cardiac surgery with cardiopulmonary bypass will be assigned to groups by simple randomization to receive either DNS or Cardi-Braun blood cardioplegia solution. The primary outcome will be the differences between groups in myocardial protection in biochemical terms (ie, perioperative troponin levels) and clinical terms (ie, presence of the composite variable acute cardiovascular event). The clinical trial will be carried out under conditions of respect for the fundamental rights of the person and the ethical principles that affect biomedical research with human beings, as well as in accordance with international recommendations contained in the Declaration of Helsinki and its subsequent revisions. RESULTS:The inclusion process started in 2018. Data cleaning and analyses are expected to take place in the fall of 2020 and the results are expected in January 2021. CONCLUSIONS:This study is particularly relevant as it will be one of the first to analyze the clinical effects of del Nido cardioplegia on the basis of direct myocardial protection parameters. In light of published studies, carrying out prospective studies based on primary clinical objectives with a larger sample, high-risk patients, and longer cardiopulmonary bypass times continues to be necessary. We believe that our study addresses an important gap in the knowledge of del Nido cardioplegia in adult patient cardiac surgery and will be able to clarify the possible benefits of this method in a large population of patients undergoing these procedures. TRIAL REGISTRATION:European Union Drug Regulating Authorities Clinical Trials Database (EudraCT) 2017-005144-14; https://www.clinicaltrialsregister.eu/ctr-search/search?query=2017-005144-14+; ClinicalTrials.gov NCT04094168; https://clinicaltrials.gov/ct2/show/NCT04094168. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):DERR1-10.2196/17826.
| S-EPMC7388037 | biostudies-literature
Project description:BackgroundBlood-based cardioplegia is the standard myocardial protection strategy in pediatric cardiac surgery. Custadiol (histidine-tryptophan-ketoglutarate), an alternative, may have some advantages but is potentially less effective at myocardial protection. This study aimed to test whether custadiol is not inferior to blood-based cardioplegia in pediatric cardiac surgery.MethodsThe study was designed as a randomized controlled trial with a blinded outcome assessment. All pediatric patients undergoing cardiac surgery with cardiopulmonary bypass and cardioplegia, including neonates, were eligible. Emergency surgery was excluded. The primary outcome was a composite of death within 30 days, an ICU stay longer than 5 days, or arrhythmia requiring intervention. Secondary endpoints included total hospital stay, inotropic score, cardiac troponin levels, ventricular function, and extended survival postdischarge. The sample size was determined a priori for a noninferiority design with an expected primary outcome of 40% and a clinical significance difference of 20%.ResultsBetween January 2018 and January 2021, 226 patients, divided into the Custodiol cardioplegia (CC) group (n = 107) and the blood cardioplegia (BC) group (n = 119), completed the study protocol. There was no difference in the composite endpoint between the CC and BC groups, 65 (60.75%) vs. 71 (59.66%), respectively (P = 0.87). The total length of stay in the hospital was 14 (Q2-Q3: 10-19) days in the CC group vs. 13 (10-21) days in the BC group (P = 0.85). The inotropic score was not significantly different between the CC and BC groups, 5 (2.6-7.45) vs. 5 (2.6-7.5), respectively (P = 0.82). The cardiac troponin level and ventricular function did not differ significantly between the two groups (P = 0.34 and P = 0.85, respectively). The median duration of follow-up was 32.75 (Q2-Q3: 18.73-41.53) months, and there was no difference in survival between the two groups (log-rank P = 0.55).ConclusionsCustodial cardioplegia is not inferior to blood cardioplegia for myocardial protection in pediatric patients. Trial registration The trial was registered in Clinicaltrials.gov, and the ClinicalTrials.gov Identifier number is NCT03082716 Date: 17/03/2017.
| S-EPMC10552411 | biostudies-literature
Project description:BackgroundDel Nido cardioplegia (DNc) was designed for superior myocardial protection during cardiopulmonary bypass (CPB). We conducted a retrospective review to explore if DNc was associated with increase in systemic ventricle dysfunction (sVD) following pediatric CPB.Methods and resultsThis single-center, retrospective study included 1534 patients undergoing CPB between 2013 and 2016, 997 prior to center-wide conversion to DNc and 537 following. The primary outcome was new postoperative ≥moderate sVD by echocardiogram. Secondary outcomes included sVD of any severity and right ventricular dysfunction. Data was evaluated by interrupted time-series analysis. Groups had similar cardiac diagnoses and surgical complexity. Del Nido cardioplegia was associated with longer median (IQR) CPB [117 (84-158) vs 108 (81-154), p = 0.04], and aortic cross-clamp [83 (55-119) vs 76 (53-106), p = 0.03], and fewer cardioplegia doses [2 (1-2) vs 3 (2-4), p < 0.0001]. Mortality was similar in both groups. Frequency of sVD was unchanged following DNc, including predetermine subgroups (neonates, infants, and prolonged cross-clamp). Logistic regression showed a significant rise in right ventricular dysfunction (OR 5.886 [95% CI: 0.588, 11.185], p = 0.03) but similar slope.ConclusionsUse of DNc was not associated with increased in reported sVD, and provided similar myocardical protection to the systemic ventricle compared to conventional cardioplegia but may possibly impact right ventricular function. Studies evaluating quantitative systolic and diastolic function are needed.
| S-EPMC9932617 | biostudies-literature
Project description:OBJECTIVES:The del Nido cardioplegia solution has been used extensively in congenital heart surgery for more than 20 years and more recently for adults. This randomized controlled trial examined whether expanding this technique to adult cardiac surgery confers benefits in surgical workflow and clinical outcome compared with blood-based cardioplegia. METHODS:Adult first-time coronary artery bypass grafting (CABG), valve, or CABG/valve surgery patients requiring cardiopulmonary bypass (CPB) were randomized to del Nido cardioplegia (n = 48) or whole blood cardioplegia (n = 41). Primary outcomes assessed myocardial preservation. Troponin I was measured at baseline, 2 hours after CPB termination, 12 and 24 hours after cardiovascular intensive care unit admission. Alpha was set at P < .001. RESULTS:Preoperative characteristics were similar between groups, including age, Society of Thoracic Surgeons risk score, CABG, and valve procedures. There was no significant difference on CPB time (97 vs 103 minutes; P = .288) or crossclamp time (70 vs 83 minutes; P = .018). The del Nido group showed higher return to spontaneous rhythm (97.7% vs 81.6%; P = .023) and fewer patients required inotropic support (65.1% vs 84.2%; P = .050), but did not reach statistical significance. Incidence of Society of Thoracic Surgeons-defined morbidity was low, with no strokes, myocardial infarctions, renal failure, or operative deaths. For del Nido group patients, troponin levels did not increase as much as for control patients (P = .040), but statistical significance was not reached. CONCLUSIONS:Evidence from this study suggests del Nido cardioplegia use in routine adult cases may be safe, result in comparable clinical outcomes, and streamline surgical workflow. The trend for troponin should be investigated further because it may suggest superior myocardial protection with the del Nido solution.
| S-EPMC5929134 | biostudies-literature
Project description:BACKGROUND:During cardiac surgery with cardiopulmonary bypass, delivery of cardioplegia solution to achieve electromechanical cardiac quiescence is obligatory. The addition of lidocaine to cardioplegia has advantages, although its consequences at a molecular level remain unclear. We performed whole-genome RNA sequencing of the human left ventricular (LV) myocardium to elucidate the differences between whole-blood (WB) cardioplegia with and without addition of lidocaine (LC) on gene expression. METHODS:We prospectively enrolled 130 patients undergoing aortic valve replacement surgery. Patients received high-potassium blood cardioplegia either with (n = 37) or without (n = 93) lidocaine. The LV apex was biopsied at baseline, and after an average of 74 minutes of cold cardioplegic arrest. We performed differential gene expression analysis for 18,258 genes between these 2 groups. Clinical and demographic variables were adjusted in the model. Gene ontology (GO) and network enrichment analysis of the retained genes were performed using g:Profiler and Cytoscape. RESULTS:A total of 1,298 genes were differentially expressed between cardioplegic treatments. Compared with the WB group, genes upregulated in the LC group were identified by network enrichment to play a protective role in ischemic injury by inhibiting apoptosis, increasing transferrin endocytosis, and increasing cell viability. Downregulated genes in the LC group were identified to play a role in inflammatory diseases, oxygen transport, and neutrophil aggregation. CONCLUSIONS:The addition of lidocaine to cardioplegia had pronounced effects on a molecular level with genes responsible for decreased inflammation, reduced intracellular calcium binding, enhanced antiapoptotic protection, augmented oxygen accessibility through transferrins, and increased cell viability showing measurable differences.
| S-EPMC6203633 | biostudies-literature
Project description:ObjectiveThis meta-analysis aimed to compare clinical outcomes of warm and cold cardioplegia in cardiac surgeries in adult patients, with trial sequential analysis (TSA) used to determine the conclusiveness of the results.MethodsElectronic searches were performed on PubMed, Medline, Scopus, EMBASE, and Cochrane library to identify all studies that compared warm and cold cardioplegia in cardiac surgeries. Primary end points were in-hospital or 30-day mortality, myocardial infarction, low cardiac output syndrome, intra-aortic balloon pump use, stroke, and new atrial fibrillation. Secondary end points were acute kidney injury, hospital length of stay, and intensive care unit length of stay. Prespecified subgroup analyses were performed for (1) studies published since publication of Fan and colleagues in 2010, (2) randomized controlled studies, (3) studies with low risk of bias, (4) coronary artery bypass graft surgeries, and (5) studies with cold blood versus those with cold crystalloid cardioplegia. TSA was performed to determine conclusiveness of the results, using on all outcomes without significant heterogeneity from studies of low risk of bias.ResultsNo significant differences were found between post-operative rates of mortality, myocardial infarction, low cardiac output syndrome, intra-aortic balloon pump use, stroke, new atrial fibrillation, and acute kidney injury between warm and cold cardioplegia. TSA concluded that current evidence was sufficient to rule out a 20% relative risk reduction in these outcomes.ConclusionsConcerning safety outcomes, current evidence suggests that the choice between warm and cold cardioplegia remains in the surgeon's preference.
| S-EPMC9390447 | biostudies-literature
Project description:BackgroundIn on-pump cardiac surgery, the albumin priming strategy could maintain colloid osmotic pressure better than crystalloid solutions and reduce excessive perioperative fluid balance. However, a high-quality meta-analysis is required to compare the safety of these approaches in perioperative red blood cell (RBC) transfusions. Owing to limited direct evidence, we conducted a network meta-analysis (NMA) to increase the pool of studies and provide indirect evidence.MethodsThe pre-defined primary outcomes were intraoperative and the first 24 h postoperative RBC transfusion volume in units. The pre-defined secondary outcome was postoperative blood loss (the first 24 h). We reviewed all randomized controlled trials comparing albumin, crystalloid, and artificial colloid priming strategies. Studies that only displayed pre-defined outcomes could be included. A pairwise meta-analysis was performed on studies that directly compared the pre-defined outcomes between albumin and crystalloids. Additionally, a random-effects network meta-analysis (NMA) model was employed to generate indirect evidence for the pre-defined outcomes between albumin and crystalloids.ResultsThe literature search identified 830 studies,10 of which were included in the final analysis. Direct meta-analysis indicated that crystalloid priming significantly decreased total perioperative RBC transfusions (MD: -0.68U; 95%CI: -1.26, -0.09U; P = 0.02) and intraoperative RBC transfusions (MD: -0.20U; 95%CI: -0.39, -0.01U; P = 0.03) compared to albumin. Postoperative RBC transfusions showed a decreasing trend in the crystalloid group; however, the difference was not statistically significant. (MD: -0.16U; 95%CI: -0.45, 0.14U; P = 0.30). After including indirect evidence, the NMA results continued to demonstrate a higher RBC receiving with the albumin priming strategy compared to crystalloids, although the differences did not reach statistical significance. For postoperative blood loss, direct evidence showed no significant differences between albumin and crystalloid priming strategies. However, NMA evidence displayed that albumin exist higher probability of reducing postoperative blood loss than crystalloid.ConclusionBoth direct and NMA evidence indicated that the albumin priming strategy resulted in more perioperative RBC transfusions than crystalloids. Considering the additional blood management burden, the application of an albumin-priming strategy in on-pump cardiac surgery still needs more consideration.
| S-EPMC10790517 | biostudies-literature