Ignite Creation Date:
2024-05-06 @ 4:59 PM
Last Modification Date:
2024-10-26 @ 2:20 PM
Study NCT ID:
NCT05159154
Status:
UNKNOWN
Last Update Posted:
2021-12-15
First Post:
2021-12-03
Brief Title:
Myocardial Work in Septic Shock Patients
Sponsor:
Humanitas Clinical and Research Center
Organization:
Humanitas Clinical and Research Center
Study Overview
Official Title:
Myocardial Work in Septic Shock Patients an Observational Study
Status:
UNKNOWN
Status Verified Date:
2021-12
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MYWORKSS
Brief Summary:
Myocardial strain analysis has emerged in the last decade as a reliable tool for studying myocardial mechanics adding information on cardiac performance when compared with traditional parameters of left ventricle LV systolic function such as ejection fraction EF
However their relative load dependency makes the myocardial deformation indices unable to account for changes in pre- and afterload
Myocardial work MW is emerging as an alternative tool for studying LV myocardial systolic function because it incorporates both deformation and load into its analysis
The purpose of this observational trial is to validate the use of MW in septic shock patients by means of consecutive echocardiographic assessment at predefined timepoints Secondarily well evaluate the impact of the vasoactive drugs used in septic shock patients vasopressors and inotropes on MW and on ventriculo-arterial coupling
However their relative load dependency makes the myocardial deformation indices unable to account for changes in pre- and afterload
Myocardial work MW is emerging as an alternative tool for studying LV myocardial systolic function because it incorporates both deformation and load into its analysis
The purpose of this observational trial is to validate the use of MW in septic shock patients by means of consecutive echocardiographic assessment at predefined timepoints Secondarily well evaluate the impact of the vasoactive drugs used in septic shock patients vasopressors and inotropes on MW and on ventriculo-arterial coupling
Detailed Description:
Myocardial strain analysis has emerged in the last decade as a reliable tool for studying myocardial mechanics adding information on cardiac performance when compared with traditional parameters of left ventricle LV systolic function such as ejection fraction EF
However their relative load dependency makes the myocardial deformation indices unable to account for changes in pre- and afterload
Myocardial work MW is emerging as an alternative tool for studying LV myocardial systolic function because it incorporates both deformation and load into its analysis In this context MW could be considered as an advancement of myocardial strain allowing to investigate LV performance also in cases of changes in afterload that could lead to misleading conclusions if relying only on strain analysis
Conditions of increased afterload can in fact negatively impact on myocardial strain even if MWis normal MW assessment was initially calculated using invasive pressure measurements which limited its widespread use in clinical practice
Recently Russell et al demonstrated that pressure-strain loops PSLs could estimate LV performance in a non-invasive manner deriving LV pressure LVP curves from non-invasively acquired brachial artery cuff pressure To date the technique has been applied in myocardial ischaemia and in identification of cardiac resynchronization therapy CRT-responders with good results
This clinical approach has been never tested insofar septic shock patients The heart is one of the organs most frequently failing in sepsis however depending on the definition used the prevalence of sepsis-induced cardiac dysfunction may vary between 10 and 70 The sepsis-induced dysregulated inflammatory response has been directly linked to cardiomyocyte dysfunction leading to a broad spectrum of cardiomyopathies including ventricles impairment during systole or diastole inadequate cardiac output oxygen delivery or primary myocardial cellular injury
Hence in septic shocked patients echocardiography plays a pivotal role identifying most of the clinical cardiac patterns related to acute systolic dysfunction and chambers dilation using basic level 2D and M-mode echocardiography A more comprehensive diagnosis can be achieved with advanced levels of competency Simultaneously hemodynamic evaluation and monitoring are possible with advanced levels of competency including the use of color Doppler spectral Doppler tissue Doppler imaging and eventually 3D or speckled tracking Specific pathways can now achieve all these steps of competence for skills certification developed by intensive care medicine societies
A variety of cardiac changes can be associated with septic shock although a normal study is not unusual 7 Abnormalities in LVEF ie contractile impairment may be associated with either a global dysfunction or exhibited as specific patterns with apical akinesis and ballooning accompanied by good basal LV contraction and is almost always reversible over days LV diastolic function and right ventricular RV function have all been described Since the resuscitation in septic shock is mainly focused on an aggressive and rapid fluid resuscitation associated with the administration of systemic vasopressors to optimize cardiac preload output and peripheral perfusion the assessment of the basal cardiac function is critical and should be routinely performed at the bedside for this purpose
The dynamic interaction between the heart and the systemic circulation allows the cardiovascular system to be efficient in providing adequate cardiac output and arterial pressures necessary for sufficient organ perfusion The cardiovascular system provides adequate pressure and flow to the peripheral organs in different physiological and pathological conditions because of the continuous modulation of the arterial system compliance stiffness and resistance with respect to LV systolic performance This challenging interplay may lead to a condition called ventriculo-arterial uncoupling when the ration between myocardial performance and peripheral response EaEes is unbalanced The hemodynamic profile of septic shock is primarily characterized by generalized vasodilatation resulting in severe hypotension with systemic hypoperfusion In most of the patients with septic shock cardiovascular efficiency is impaired and the EaEes becomes uncoupled EaEes 1 Th e hemodynamic profile is characterized by both the significant increase in Ea and the decrease in Ees Because the increase in Ea is generally induced by pharmacological vasoconstriction norepinephrine and the consequent increase in arterial tone a decrease in Ees generally depends on the reduction in myocardial contractility Whatever the underlying mechanism when A-V uncoupling occurs in septic shock the cardiac energetics are unfavorable and are often sacrificed to maintain tissue perfusion
The purpose of this observational trial is to validate the use of MW in septic shock patients by means of consecutive echocardiographic assessment at predefined timepoints Secondarily well evaluate the impact of the vasoactive drugs used in septic shock patients vasopressors and inotropes on MW and on ventriculo-arterial coupling
However their relative load dependency makes the myocardial deformation indices unable to account for changes in pre- and afterload
Myocardial work MW is emerging as an alternative tool for studying LV myocardial systolic function because it incorporates both deformation and load into its analysis In this context MW could be considered as an advancement of myocardial strain allowing to investigate LV performance also in cases of changes in afterload that could lead to misleading conclusions if relying only on strain analysis
Conditions of increased afterload can in fact negatively impact on myocardial strain even if MWis normal MW assessment was initially calculated using invasive pressure measurements which limited its widespread use in clinical practice
Recently Russell et al demonstrated that pressure-strain loops PSLs could estimate LV performance in a non-invasive manner deriving LV pressure LVP curves from non-invasively acquired brachial artery cuff pressure To date the technique has been applied in myocardial ischaemia and in identification of cardiac resynchronization therapy CRT-responders with good results
This clinical approach has been never tested insofar septic shock patients The heart is one of the organs most frequently failing in sepsis however depending on the definition used the prevalence of sepsis-induced cardiac dysfunction may vary between 10 and 70 The sepsis-induced dysregulated inflammatory response has been directly linked to cardiomyocyte dysfunction leading to a broad spectrum of cardiomyopathies including ventricles impairment during systole or diastole inadequate cardiac output oxygen delivery or primary myocardial cellular injury
Hence in septic shocked patients echocardiography plays a pivotal role identifying most of the clinical cardiac patterns related to acute systolic dysfunction and chambers dilation using basic level 2D and M-mode echocardiography A more comprehensive diagnosis can be achieved with advanced levels of competency Simultaneously hemodynamic evaluation and monitoring are possible with advanced levels of competency including the use of color Doppler spectral Doppler tissue Doppler imaging and eventually 3D or speckled tracking Specific pathways can now achieve all these steps of competence for skills certification developed by intensive care medicine societies
A variety of cardiac changes can be associated with septic shock although a normal study is not unusual 7 Abnormalities in LVEF ie contractile impairment may be associated with either a global dysfunction or exhibited as specific patterns with apical akinesis and ballooning accompanied by good basal LV contraction and is almost always reversible over days LV diastolic function and right ventricular RV function have all been described Since the resuscitation in septic shock is mainly focused on an aggressive and rapid fluid resuscitation associated with the administration of systemic vasopressors to optimize cardiac preload output and peripheral perfusion the assessment of the basal cardiac function is critical and should be routinely performed at the bedside for this purpose
The dynamic interaction between the heart and the systemic circulation allows the cardiovascular system to be efficient in providing adequate cardiac output and arterial pressures necessary for sufficient organ perfusion The cardiovascular system provides adequate pressure and flow to the peripheral organs in different physiological and pathological conditions because of the continuous modulation of the arterial system compliance stiffness and resistance with respect to LV systolic performance This challenging interplay may lead to a condition called ventriculo-arterial uncoupling when the ration between myocardial performance and peripheral response EaEes is unbalanced The hemodynamic profile of septic shock is primarily characterized by generalized vasodilatation resulting in severe hypotension with systemic hypoperfusion In most of the patients with septic shock cardiovascular efficiency is impaired and the EaEes becomes uncoupled EaEes 1 Th e hemodynamic profile is characterized by both the significant increase in Ea and the decrease in Ees Because the increase in Ea is generally induced by pharmacological vasoconstriction norepinephrine and the consequent increase in arterial tone a decrease in Ees generally depends on the reduction in myocardial contractility Whatever the underlying mechanism when A-V uncoupling occurs in septic shock the cardiac energetics are unfavorable and are often sacrificed to maintain tissue perfusion
The purpose of this observational trial is to validate the use of MW in septic shock patients by means of consecutive echocardiographic assessment at predefined timepoints Secondarily well evaluate the impact of the vasoactive drugs used in septic shock patients vasopressors and inotropes on MW and on ventriculo-arterial coupling
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None