{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,29]],"date-time":"2026-06-29T10:48:28Z","timestamp":1782730108335,"version":"3.54.5"},"reference-count":25,"publisher":"BMJ","issue":"9","license":[{"start":{"date-parts":[[2020,9,25]],"date-time":"2020-09-25T00:00:00Z","timestamp":1600992000000},"content-version":"unspecified","delay-in-days":24,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2020,8,7]]},"published-print":{"date-parts":[[2020,9]]},"abstract":"<jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>Cardiogenic shock is a condition of low cardiac output that represents the end stage of a progressive deterioration of cardiac function. The main cause is ischaemic heart disease, but there are several non-ischaemic causes, including sepsis. The use of levosimendan in cardiogenic shock during sepsis is still under debate.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>\n                      We are conducting an observational, single-centre, not-for-profit study enrolling patients aged 18\u201380 years old admitted to the intensive care unit with a diagnosis of septic shock. Patients will be monitored with the EV1000\/VolumeView device (Edwards Lifesciences, Irvine, USA). Patients with cardiac index (CI) values &lt;2.5 L\/min\/m\n                      <jats:sup>2<\/jats:sup>\n                      and\/or stroke volume index (SVI) &lt;30 mL\/beat\/m\n                      <jats:sup>2<\/jats:sup>\n                      are considered eligible for the study. Enrolled participants will undergo an echocardiographic examination using the Vivid S6 ultrasound machine (General Electric, Northville, Michigan) and a 3.6 MHz cardiology probe through which the apical projections of chambers 2, 3 and 4 will be acquired; this is necessary to calculate the global longitudinal strain (GLS) using EchoPAC* Clinical Workstation Software (General Electric). A dobutamine infusion will be started in these patients; 24 hours later CI and SVI will be recalculated using EV1000\/VolumeView and then a levosimendan infusion will begin for 24 hours. Once the infusion cycle of the calcium-sensitising drug has been carried out, the infusion of dobutamine will be reduced until it stops, and the CI, SVI, GLS and arterial elastance (Ea):Ventricular Elastance (Ees) will be re-evaluated. The primary endpoint is recovery of GLS \u226515% and the secondary endpoint is a relative reduction in mortality of 15%.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics and dissemination<\/jats:title>\n                    <jats:p>The investigators declare that the study will be conducted in full compliance with international regulations (EU Directive 2016\/679\/EC) and national implementation (DM 15 July 1997; 211\/2003; 200\/2007) regarding the clinical trial and the principles of the Declaration of Helsinki. Study results will be disseminated through peer-reviewed journals and conferences. Ethical approval for this study has been given by Comitato Etico Regione Toscana - Area Vasta Centro, Florence, Italy (ethical committee number: 13875_oss) on 25 May 2019 (Chairperson Professor Marco Marchi).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number<\/jats:title>\n                    <jats:p>\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT04141410\">NCT04141410<\/jats:ext-link>\n                      .\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2020-037188","type":"journal-article","created":{"date-parts":[[2020,9,25]],"date-time":"2020-09-25T17:36:05Z","timestamp":1601055365000},"page":"e037188","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":6,"title":["Levosimendan and Global Longitudinal Strain Assessment in Sepsis (GLASSES 1): a study protocol for an observational study"],"prefix":"10.1136","volume":"10","clinical-trial-number":[{"clinical-trial-number":"nct04141410","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-9596-458X","authenticated-orcid":false,"given":"Iacopo","family":"Cappellini","sequence":"first","affiliation":[{"name":"Department of Critical Care Section of Anesthesiology and Intensive Care, Azienda USL Toscana Centro, Prato, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alessandra","family":"Melai","sequence":"additional","affiliation":[{"name":"Department of Critical Care Section of Anesthesiology and Intensive Care, Azienda USL Toscana Centro, Prato, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lucia","family":"Zamidei","sequence":"additional","affiliation":[{"name":"Department of Critical Care Section of Anesthesiology and Intensive Care, Azienda USL Toscana Centro, Prato, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maddalena","family":"Parise","sequence":"additional","affiliation":[{"name":"Department of Critical Care Section of Anesthesiology and Intensive Care, Azienda USL Toscana Centro, Prato, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Simone","family":"Cipani","sequence":"additional","affiliation":[{"name":"Department of Critical Care Section of Anesthesiology and Intensive Care, Azienda USL Toscana Centro, Figline Valdarno, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Guglielmo","family":"Consales","sequence":"additional","affiliation":[{"name":"Department of Critical Care Section of Anesthesiology and Intensive Care, Azienda USL Toscana Centro, Prato, 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