Levosimendan and Global Longitudinal Strain Assessment in Sepsis (GLASSES 1): a study protocol for an observational study

Levosimendan and Global Longitudinal Strain Assessment in Sepsis (GLASSES 1): a study protocol for an observational study

IntroductionCardiogenic 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 d...

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Bibliographic Details
Published in:BMJ open Vol. 10; no. 9; p. e037188
Main Authors: Cappellini, Iacopo, Melai, Alessandra, Zamidei, Lucia, Parise, Maddalena, Cipani, Simone, Consales, Guglielmo
Format: Journal Article
Language:English
Published: England BMJ Publishing Group LTD 25-09-2020
BMJ Publishing Group
Series:Protocol
Subjects:
Adolescent
Adult
Aged
Aged, 80 and over
Cardiac function
Cardiovascular disease
Drugs
Ejection fraction
Heart
Humans
Intensive Care
Italy
Michigan
Middle Aged
Mortality
Observational studies
Observational Studies as Topic
Patients
Sepsis
Sepsis - drug therapy
Shock, Septic - drug therapy
Simendan
Ultrasonic imaging
Young Adult
Italy
Michigan
levosimendan
septic shock
cardiogenic shock
sepsis
speckle tracking echocardiography
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Summary:IntroductionCardiogenic 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.MethodsWe 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 disseminationThe 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 numberNCT04141410.
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ISSN:2044-6055
2044-6055
DOI:10.1136/bmjopen-2020-037188