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This study therefore sought to explore the safety and efficacy of prophylactic levosimendan administration to pediatric patients as a means of preventing low cardiac output syndrome (LCOS) based upon hemodynamic, biomarker, and pharmacokinetic readouts.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>This was a single-center, double-blind, randomized, placebo-controlled trial. Patients \u2264\u200948\u2009months old were enrolled between July 2018 and April 2019 and were randomly assigned to groups that received either placebo or levosimendan infusions for 48\u2009h post-surgery, along with all other standard methods of care. LCOS incidence was the primary outcome of this study.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      A total of 187 patients were enrolled, of whom 94 and 93 received levosimendan and placebo, respectively. LCOS incidence did not differ significantly between the levosimendan and placebo groups (10 [10.6%] versus 18 [19.4%] patients, respectively; 95% confidence interval [CI] 0.19\u20131.13;\n                      <jats:italic>p<\/jats:italic>\n                      \u2009=\u20090.090) nor did 90-day mortality (3 [3.2%] versus 4 [4.3%] patients, CI 0.14\u20133.69,\n                      <jats:italic>p<\/jats:italic>\n                      \u2009=\u20090.693), duration of mechanical ventilation (median, 47.5\u2009h and 39.5\u2009h, respectively;\n                      <jats:italic>p<\/jats:italic>\n                      \u2009=\u20090.532), ICU stay (median, 114.5\u2009h and 118\u2009h, respectively;\n                      <jats:italic>p<\/jats:italic>\n                      \u2009=\u20090.442), and hospital stay (median, 20\u2009days and 20\u2009days, respectively;\n                      <jats:italic>p<\/jats:italic>\n                      \u2009=\u20090.806). The incidence of hypotension and cardiac arrhythmia did not differ significantly between the groups. Levels of levosimendan fell rapidly without any plateau in plasma concentrations during infusion. A multiple logistic regression indicated that randomization to the levosimendan group was a predictor of LCOS.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Prophylactic levosimendan administration was safe in pediatric patients and had some benefit to postoperative hemodynamic parameters, but failed to provide significant benefit with respect to LCOS or 90-day mortality relative to placebo.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration<\/jats:title>\n                    <jats:p>\n                      Name of the registry: Safety evaluation and therapeutic effect of levosimendan on the low cardiac output syndrome in patients after cardiopulmonary bypass. Trial registration number: ChiCTR1800016594. Date of registration: 11 June 2018. URL of trial registry record:\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"http:\/\/www.chictr.org.cn\/index.aspx\">http:\/\/www.chictr.org.cn\/index.aspx<\/jats:ext-link>\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1186\/s13054-019-2704-2","type":"journal-article","created":{"date-parts":[[2019,12,30]],"date-time":"2019-12-30T08:02:39Z","timestamp":1577692959000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":39,"title":["Prophylactic use of levosimendan in pediatric patients undergoing cardiac surgery: a prospective randomized controlled trial"],"prefix":"10.1186","volume":"23","author":[{"given":"Anbiao","family":"Wang","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chaomei","family":"Cui","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yiou","family":"Fan","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jie","family":"Zi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jie","family":"Zhang","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Guanglai","family":"Wang","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fang","family":"Wang","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jun","family":"Wang","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5756-4101","authenticated-orcid":false,"given":"Qi","family":"Tan","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2019,12,30]]},"reference":[{"key":"2704_CR1","doi-asserted-by":"publisher","first-page":"70","DOI":"10.1186\/s13019-019-0900-4","volume":"14","author":"JS Huang","year":"2019","unstructured":"Huang JS, Chen Q, Chen LW, Kuo YR, Hong ZN, Cao H. 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As most participants were newborns or infants who were lacking the capacity to give consent, approval was granted by the guardian of patients.","order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"Not applicable","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"The authors declare that they have no competing interests.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"428"}}