- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT05159154
Myocardial Work in Septic Shock Patients (MYWORKSS)
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.
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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Anticipé)
Contacts et emplacements
Coordonnées de l'étude
- Nom: Antonio Messina, PhD
- Numéro de téléphone: 02-82241
- E-mail: antonio.messina@humanitas.it
Lieux d'étude
-
-
Milan
-
Rozzano, Milan, Italie, 20089
- Humanitas Clinical and Research Center
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
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.
La description
Inclusion criteria:
- Expected to be ventilated for > 48 hours
- Age > 50
Exclusion criteria:
- 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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
---|---|
Septic Shock Patients
Patients admitted with diagnosis of septic shock
|
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®)
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Myocardial Work
Délai: 24h from intensive care unit admission
|
Quantification of Myocardial Work Index
|
24h from intensive care unit admission
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Myocardial Work
Délai: 60 +/- 12 h from intensive care unit admission
|
Quantification of Myocardial Work Index
|
60 +/- 12 h from intensive care unit admission
|
Myocardial Work
Délai: 7 days from intensive care unit admission
|
Quantification of Myocardial Work Index
|
7 days from intensive care unit admission
|
Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Myocardial Work
Délai: 1h from norephinefrine infusion start
|
Quantification of Myocardial Work Index
|
1h from norephinefrine infusion start
|
Myocardial Work
Délai: 1h from norephinefrine infusion dose increase
|
Quantification of Myocardial Work Index
|
1h from norephinefrine infusion dose increase
|
Myocardial Work
Délai: 6h from norephinefrine infusion dose increase
|
Quantification of Myocardial Work Index
|
6h from norephinefrine infusion dose increase
|
Myocardial Work
Délai: 1h from dobutamine infusion start
|
Quantification of Myocardial Work Index
|
1h from dobutamine infusion start
|
Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Anticipé)
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- MYWORKSS
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
Essais cliniques sur Myocardial Work
-
The Mediterranean Institute for the Advance of...Preventive Services and Health Promotion Research Network; University of Malaga et autres collaborateursActif, ne recrute pas
-
University of MichiganNational Institute of Mental Health (NIMH); University of Pittsburgh; Michigan... et autres collaborateursInscription sur invitationTroubles du spectre autistique | AutismeÉtats-Unis
-
East Carolina UniversityComplétéActivité physiqueÉtats-Unis
-
Sara RosenblumComplété
-
Psychiatric Research Unit, Region Zealand, DenmarkRetiréHospitalisation psychiatrique