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Septic ShockMYWORKSSNCT05159154

Myocardial Work in Septic Shock Patients

An observational study of Septic Shock and Critical Illness, run by Humanitas Clinical and Research Center at 1 site in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Septic Shock, Critical Illness
What is being tested?
Myocardial Work
Type of treatment
Medical device
How many people
45 participants
Where
1 siteItaly
Study dates
1 Jan 2022to 1 Jan 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients with diagnosis of septic shock < 24h and acute circulatory failure was defined as at least one of the following criteria: * Systolic arterial pressure ≤ 90 mmHg (or a decrease > 50 mm Hg in hypertensive patients) or a mean arterial pressure (MAP) ≤ 70 mmHg or the use of vasopressors to maintain SAP > 90 mmHg. * skin mottling * tachycardia ≥100 beats/min * urinary flow ≤ 0.5 mL/kg for at least 2 hours * blood lactate level ≥ 2 mmol/L.

Who may be able to join

  • Expected to be ventilated for > 48 hours
  • Age > 50

Who cannot join

  • Atrial fibrillation (at the admission or during intensive care unit stay);
  • Neuromuscular disorders;
  • Home ventilation prior to admission;
  • Palliative intubation;
  • Intubation for an indication to tracheostomy;
  • Poor acoustic window (after the first assessment);
  • Severe mitral and/or aortic valve stenosis or regurgitation

Trial locations and contacts

1 site in 1 country.

Antonio Messina, PhD contact

02-82241

antonio.messina@humanitas.it

Italy1 site
  • Humanitas Clinical and Research center

    Rozzano, Milan, 20089

Other trials in Italy

About this study

Official title: Myocardial Work in Septic Shock Patients: an Observational Study

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.

Read more

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, we'll evaluate the impact of the vasoactive drugs used in septic shock patients (vasopressors and inotropes) on MW and on ventriculo-arterial coupling.

Read the 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 (i.e., 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 (Ea/Ees) 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 Ea/Ees becomes uncoupled (Ea/Ees > 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, we'll evaluate the impact of the vasoactive drugs used in septic shock patients (vasopressors and inotropes) on MW and on ventriculo-arterial coupling.

Being tested
Myocardial Work
Medical subject headings
Shock, Septic, Critical Illness

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Myocardial WorkDevice

    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. This parameter will be evaluated by using an echographer equipped with a specific software for the analysis (Ecog Vivid E95 Ultra GE®)

Study groups in NCT05159154
Study groupRoleWhat they receive
Septic Shock PatientsPatients admitted with diagnosis of septic shock
Receives: Device: Myocardial Work

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Myocardial Work

    Quantification of Myocardial Work Index

    Measured: 24h from intensive care unit admission

Secondary outcomes (2)
  1. Myocardial Work

    Quantification of Myocardial Work Index

    Measured: 60 +/- 12 h from intensive care unit admission

  2. Myocardial Work

    Quantification of Myocardial Work Index

    Measured: 7 days from intensive care unit admission

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Dec 2021
  2. Study start1 Jan 2022 (estimated)
  3. Primary completion1 Jan 2023 (estimated)
  4. Study completion1 Jan 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
45 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05159154
Sponsor's protocol ID
MYWORKSS
Acronym
MYWORKSS
Status last verified
Dec 2021
First submitted
3 Dec 2021
Last updated
15 Dec 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request

Questions about this trial

What is this clinical trial studying?

An observational study of Septic Shock and Critical Illness, run by Humanitas Clinical and Research Center at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 15 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Antonio Messina, PhD (02-82241, antonio.messina@humanitas.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Myocardial Work (time frame: 24h from intensive care unit admission). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2021.

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Myocardial Work in Septic Shock Patients (NCT05159154) | AzTrials