Levosimendan and Global Longitudinal Strain Assessment in Sepsis (GLASSES 1): a study protocol for an observational
Iacopo Cappellini1, Alessandra Melai2, Lucia Zamidei2
1Department of Critical Care Section of Anesthesiology and Intensive Care, Azienda USL Toscana Centro, Prato, Italy iacopo.cappellini@uslcentro.toscana.it.
Insights
This study investigates levosimendan
Area of Science:
- Critical Care Medicine
- Cardiology
- Pharmacology
Background:
- Cardiogenic shock, often caused by ischemic heart disease or sepsis, signifies end-stage cardiac dysfunction.
- The efficacy of levosimendan in managing cardiogenic shock specifically during sepsis remains an area of ongoing clinical investigation.
- Septic shock presents complex hemodynamic challenges, necessitating advanced monitoring and therapeutic strategies.
Purpose of the Study:
- To evaluate the impact of levosimendan on cardiac function, specifically global longitudinal strain (GLS), in patients with septic shock.
- To assess the secondary outcome of mortality reduction in patients with septic shock treated with levosimendan.
- To explore the combined use of dobutamine and levosimendan in improving hemodynamic parameters.
Main Methods:
- An observational, single-center study enrolled 18-80 year olds with septic shock and low cardiac index (<2.5 L/min/m²)/stroke volume index (<30 mL/beat/m²).
- Hemodynamic monitoring utilized the EV1000/VolumeView device, with echocardiography (Vivid S6) to calculate global longitudinal strain (GLS).
- Patients received dobutamine, followed by levosimendan, with serial assessments of cardiac index (CI), stroke volume index (SVI), and GLS.
Main Results:
- Primary endpoint: recovery of GLS ≥15%.
- Secondary endpoint: a relative reduction in mortality of 15%.
- Hemodynamic parameters including CI, SVI, and the ratio of arterial elastance (Ea) to ventricular elastance (Ees) were re-evaluated post-intervention.
Conclusions:
- The study aims to provide data on the effectiveness of levosimendan in improving myocardial function in septic shock.
- Findings will contribute to the understanding of levosimendan's role in managing complex cardiogenic shock during sepsis.
- Results will be disseminated through peer-reviewed publications and conference presentations.
Introduction:
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.
Methods:
We are conducting an observational, single-centre, not-for-profit study enrolling patients aged 18-80 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 <2.5 L/min/m2 and/or stroke volume index (SVI) <30 mL/beat/m2 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 ≥15% and the secondary endpoint is a relative reduction in mortality of 15%.
Ethics And Dissemination:
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).
Trial Registration Number:
NCT04141410.
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