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Perioperative antibiotics in pediatric cardiac surgery: protocol for a systematic review Anand, Vijay; Bates, Angela; Featherstone, Robin; Murthy, Srinivas May 30, 2017

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PROTOCOLinsnic sstaot onasacuamanestablished adjuncts to reducing the incidence of infec- single-dose prophylaxis to continuing antibiotics until allof antibioticsure has beened varies; al-Anand et al. Systematic Reviews  (2017) 6:107 DOI 10.1186/s13643-017-0502-ymycin for high rates of MRSA.3University of British Columbia, 4500 Oak Street, Vancouver, CanadaFull list of author information is available at the end of the articlethough, this is primarily contingent upon the endemicorganisms present in specific institutions, i.e., vanco-* Correspondence: Srinivas.murthy@cw.bc.cacontext of increasing attention to antimicrobial resist-ance predicated upon the overuse of antibiotics, address-ing this issue is timely [11].antibiotic regimens vary again, from 48 hto antibiotics continuing until chest closachieved. Further, the type of antibiotic ustion [10]; however, the nature, timing, and duration ofadministration remain undetermined. Further, in thechest tubes and central venous catheters have been re-moved [10]. In children with delayed sternal closure,Antibiotic use in the perioperative period are well-Study registration number: PROSPERO CRD42016052978CKeywords: Healthcare-associated infections, Pediatrics, Cardiac surgeryBackgroundDescription of the problemPost-operative infections in pediatric cardiac surgery re-main an ongoing clinical challenge. The burden of dis-ease has a wide range, dependent on the case seriesexamined, ranging from approximately 1 to 18% in chil-dren with delayed sternal closure [1–4]. There are manyfactors that contribute to increased risk of infection, in-cluding overall acuity, age, delayed sternal closure, ster-oid use, and length-of-stay in ICU [5–8]. The presenceof infection is associated with worsened outcomes andincreased costs [9].Description of the interventionAntibiotic prophylaxis for surgical procedures is awell-established practice that reduces surgical-site in-fections. By preventing translocation of bacteria fromthe skin, antibiotic prophylaxis reduces the rate ofpost-operative infections in all types of procedures,from clean to dirty. As a clean procedure, pediatriccardiac surgeries should have a lower risk for infec-tion; however, given the severity of illness and pro-longed stays in intensive care, infections remain anongoing challenge.Antibiotic prophylaxis in pediatric cardiac surgerytakes numerous forms. Regimens vary greatly, fromuse this systematic review to inform clinical guidelines, which will be disseminated in a separate stand-alone publication.Perioperative antibioticssurgery: protocol for a syVijay Anand1, Angela Bates2, Robin Featherstone1 and SriAbstractBackground: Post-operative infections in pediatric cardiabetween 1 and 20%. Perioperative antibiotics remain thetype of antibiotic and duration of administration remain pinformal surveys are very high. Rates of antibiotic-resistanMethods/design: We will identify all controlled observatioprophylactic antibiotic use in pediatric cardiac surgery. Dataproceedings from recent relevant scientific meetings. For edata extraction, risk of bias assessment, and evaluation of qDiscussion: We will report the results of this review in agreefindings at relevant critical care and cardiology conferences© The Author(s). 2017 Open Access This articInternational License (http://creativecommonsreproduction in any medium, provided you gthe Creative Commons license, and indicate if(http://creativecommons.org/publicdomain/zeOpen Accesspediatric cardiactematic reviewvas Murthy3*urgery are an ongoing clinical challenge, with ratesndard for prevention of surgical-site infections, but theorly defined. Current levels of practice variation throughrganisms are increasing steadily around the world.l studies and randomized controlled trials examiningources will include MEDLINE, EMBASE, CENTRAL, andh included study, we will conduct duplicate independentlity of evidence using the GRADE approach.ent with the PRISMA statement and disseminate ourd through publication in peer-reviewed journals. We willle is distributed under the terms of the Creative Commons Attribution 4.0.org/licenses/by/4.0/), which permits unrestricted use, distribution, andive appropriate credit to the original author(s) and the source, provide a link tochanges were made. The Creative Commons Public Domain Dedication waiverro/1.0/) applies to the data made available in this article, unless otherwise stated.Anand et al. Systematic Reviews  (2017) 6:107 Page 2 of 3Why is it important to conduct this reviewGiven the issue of antimicrobial resistance and a focus onantimicrobial stewardship in critical care, the varied ratesof post-operative infections, and the incredibly diverseregimens used for antibiotic prophylaxis, it is timely tosystematically review the literature to determine the opti-mal strategy to prevent infections in critically ill children.Further, data guidance from adult-specific randomized tri-als are less relevant to children, given the very differentphysiology and infectious risks in the two cohorts [12, 13].Research questionIs a shortened course of perioperative antibiotics in chil-dren undergoing cardiac surgery as safe as a prolongedcourse of perioperative antibiotics?Methods and analysisCriteria for selecting studiesTypes of studiesWe will include all controlled observational studies(case-control or cohort) and randomized trials, exclud-ing case reports or case series, with no restrictions basedon language or quality. We will only include papers pub-lished after 1990, given the large changes in practicesince that point in time in pediatric cardiac surgery.Types of participantsThe population of interest is children (<18 years) under-going open heart surgery.Types of interventionsThe interventions examined include any systemic antibioticregimen used for the prevention of infection in childrenhaving undergone cardiac surgery. We will include studiesthat report the nature (drug, duration) of antibiotics admin-istered. We will exclude studies that exclusively report anti-biotics used for the treatment of established infections. Wewill exclude studies that exclusively report on the pre-operative use of decolonization regimens.Types of outcome measuresWe will include studies that report the incidence of in-fection, as defined by the individual studies. Other out-comes of interest include, if reported: length-of-ICU-stay, mortality, cost of care, antibiotic-associated adverseevents, and presence of antibiotic-resistant organisms(as defined by individual authors).Search methodsWe will perform a search of the following databases forrelevant studies: MEDLINE, EMBASE, and the CochraneCentral Register of Controlled Trials (CENTRAL). Thepeer-reviewed MEDLINE search strategy is included inAdditional file 1, with similar searches with adaptedkeywords for other databases. To locate in-process andunpublished studies, we will also search trial registries,ClinicalTrials.gov and the World Health Organization’sInternational Clinical Trial Registry Platform (WHOICTRP), from 2014 to 2017.We will screen reference lists of included studies andrelevant reviews for eligible articles. We will also manu-ally screen conference proceedings from 2014 to 2017for the following scientific meetings: Society of CriticalCare Medicine, Pediatric Cardiac Intensive Care Society,Society of Thoracic Surgeons, American Heart Associ-ation, and World Congress of Pediatric Cardiology andCardiac Surgery.Search results will be exported to the EndNote X7 cit-ation manager program. Preliminary scoping searcheshave been performed and no randomized trials havebeen found.Study recordsPairs of two reviewers will independently screen titlesand abstracts using a pretested electronic screening form(www.covidence.org), including any article for full-textreview unless both reviewers exclude. Pairs of two re-viewers will then independently screen all full-text arti-cles using specific eligibility criteria through thisplatform, resolving disagreements by consensus, andreporting a Cohen’s k for full-text eligibility screening.Data collectionTeams of two reviewers will perform data extractionindependently and in duplicate using data collectionforms through Covidence, collecting information per-taining to the study design, patient characteristics,intervention (and comparator, if applicable), and clin-ical outcomes. Interventions will include specifyingthe antibiotic used, doses (if available), the durationof use, and specific reasons for altering these prac-tices. Outcomes will include a primary outcome of in-cidence of nosocomial infection (as defined by theindividual paper), mortality, duration of mechanicalventilation, and duration of intensive care unit stay.Conflicts will be resolved through discussion.Risk of bias assessmentFor observational studies, we will use the risk of biastools for cohort and case-control studies developed bythe Clinical Advances Through Research and Informa-tion Translation (CLARITY) group at McMaster univer-sity [14, 15]. These tools evaluate the selection ofgroups, the adequacy of assessment of prognostic fac-tors, the assessment of exposures and outcomes, and thesimilarity of co-interventions between groups. We willassess the overall quality of data for our primary out-come using the GRADE approach.Competing interestsThe authors declare that they have no competing interests.Anand et al. Systematic Reviews  (2017) 6:107 Page 3 of 3Summarizing data and treatment effectGiven the expected heterogeneity of the study designs, wewill not perform a meta-analysis. We will provide quantita-tive summaries where available of relevant treatment effectsof different antibiotic treatment durations of individualstudies, with tabular results of included studies.Subgroup analysis and investigation of heterogeneitySubgroup overviews will be performed for children with de-layed sternal closure. Given the absence of a planned meta-analysis, quantitative subgroup analysis will be deferred.DiscussionPerioperative infections are a common cause of post-operative morbidity in this high-risk population. Optimizingthe antibiotic regimens for these children is a frequent clin-ical conversation that is woefully understudied despite itswidespread practice. As a comparative effectiveness pro-gram, we aim to determine the best method to prevent in-fections, without increasing the adverse effects of antibioticssuch as increasing resistance and individual adverse effects.Ethics and disseminationWe did not require ethics approval for this study. Wewill report this review in accordance with the PRISMAstatement [16]. This protocol has been registered at thePROSPERO database (CRD42016052978C) and is re-ported in accordance with the Preferred Reporting Itemsfor Systematic Reviews and Meta-Analyses Protocols(PRISMA-P) guidelines (see Additional file 2) [17].There is no specific funding attached to this systematicreview. We will disseminate our findings by producingclinical guidelines, as well as conference presentationsand publication in a peer-reviewed journal.Additional filesAdditional file 1: Search Strategy, filename: Appendix 1. (DOCX 84 kb)Additional file 2: PRISMA-P Checklist, filename: PRISMA-P 2015 checklistantibiotics. (DOCX 37 kb)AbbreviationsCLARITY: Clinical advances through research and information translation;PRISMA: Preferred Reporting Items for Systematic Reviews and Meta-AnalysesAcknowledgementsNone.Availability of data and materialsNot applicable.FundingNone.Authors’ contributionsVA, AB, RF, and SM contributed to the design and conduct of the studyand reviewed the manuscript. All authors read and approved the finalmanuscript.Ethical approval and consent to participateNot applicable.Publisher’s NoteSpringer Nature remains neutral with regard to jurisdictional claims inpublished maps and institutional affiliations.Author details1University of Alberta, Edmonton, Canada. 2University of Pennsylvania,Philadelphia, USA. 3University of British Columbia, 4500 Oak Street,Vancouver, Canada.Received: 8 March 2017 Accepted: 18 May 2017References1. Tortoriello TA, Friedman JD, McKenzie ED, et al. Mediastinitis after pediatriccardiac surgery: a 15-year experience at a single institution. Ann ThoracSurg. 2003;76:1655–60.2. Al-Sehly AA, Robinson JL, Lee BE, et al. Pediatric poststernotomy mediastinitis.Ann Thorac Surg. 2005;80:2314–20.3. Nelson-McMillan K, Hornik CP, He X, et al. Delayed sternal closure in infantheart surgery-the importance of where and when: an analysis of the STScongenital heart surgery database. ann thorac surg. 2016;102:1565–72.4. Agus MS, Steil GM, Wypij D, et al. Tight glycemic control versus standardcare after pediatric cardiac surgery. N Engl J Med. 2012;367:1208–19.5. Bowman ME, Rebeyka IM, Ross DB, Quinonez LG, Forgie SE. Risk factors forsurgical site infection after delayed sternal closure. Am J Infect Control.2013;41:464–5.6. Mastropietro CW, Barrett R, Davalos MC, et al. Cumulative corticosteroidexposure and infection risk after complex pediatric cardiac surgery. AnnThorac Surg. 2013;95:2133–9.7. Ben-Ami E, Levy I, Katz J, Dagan O, Shalit I. Risk factors for sternal woundinfection in children undergoing cardiac surgery: a case-control study. JHosp Infect. 2008;70:335–40.8. Kagen J, Lautenbach E, Bilker WB, et al. Risk factors for mediastinitisfollowing median sternotomy in children. Pediatr Infect Dis J. 2007;26:613–8.9. Braxton JH, Marrin CA, McGrath PD, et al. 10-year follow-up of patients withand without mediastinitis. Semin Thorac Cardiovasc Surg. 2004;16:70–6.10. Alphonso N, Anagnostopoulos PV, Scarpace S, et al. Perioperative antibioticprophylaxis in paediatric cardiac surgery. Cardiol Young. 2007;17:12–25.11. Holmes AH, Moore LS, Sundsfjord A, et al. Understanding the mechanismsand drivers of antimicrobial resistance. Lancet. 2016;387:176–87.12. Harbarth S, Samore MH, Lichtenberg D, Carmeli Y. Prolonged antibioticprophylaxis after cardiovascular surgery and its effect on surgical siteinfections and antimicrobial resistance. Circulation. 2000;101:2916–21.13. Bratzler DW, Dellinger EP, Olsen KM, et al. Clinical practice guidelines forantimicrobial prophylaxis in surgery. Am J Health Syst Pharm. 2013;70:195–283.14. Tool to Assess Risk of Bias in Case-control Studies. (Accessed 24 Apr 2017 athttps://www.evidencepartners.com/wp-content/uploads/2014/02/Tool-to-Assess-Risk-of-Bias-in-Case-Control-Studies-Aug-21_2011.doc).15. Tool to Assess Risk of Bias in Cohort Studies. (Accessed 24 Apr 2017, athttps://www.evidencepartners.com/wp-content/uploads/2014/02/Tool-to-Assess-Risk-of-Bias-in-Cohort-Studies.doc).16. Moher D, Liberati A, Tetzlaff J, Altman DG, Group P. Preferred reportingitems for systematic reviews and meta-analyses: the PRISMA statement.PLoS Med. 2009;6:e1000097.17. Moher D, Shamseer L, Clarke M, et al. Preferred Reporting Items forSystematic Review and Meta-Analysis Protocols (PRISMA-P) 2015 statement.Syst Rev. 2015;4:1.

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