Myocardial Work in Septic Shock Patients

NCT05159154 | Unknown

• 1 other identifier: MYWORKSS
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

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

Conditions

Septic Shock; Critical Illness

Outcome Measures

Primary Outcomes (1)

• Myocardial Work

  Quantification of Myocardial Work Index

  24h from intensive care unit admission

Secondary Outcomes (2)

• Myocardial Work

  60 +/- 12 h from intensive care unit admission

• Myocardial Work

  7 days from intensive care unit admission

Other Outcomes (4)

• Myocardial Work

  1h from norephinefrine infusion start

• Myocardial Work

  1h from norephinefrine infusion dose increase

• Myocardial Work

  6h from norephinefrine infusion dose increase

Study Arms (1)

Septic Shock Patients

Patients admitted with diagnosis of septic shock

Device: Myocardial Work

Interventions

Myocardial Work DEVICE

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®)

Septic Shock Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Humanitas Clinical and Research Center: lead

Study Sites (1)

Humanitas Clinical and Research center

Rozzano, Milan, 20089, Italy

Location

MeSH Terms

Conditions

Shock, Septic; Critical Illness

Condition Hierarchy (Ancestors)

Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock; Disease Attributes

Central Study Contacts

Antonio Messina, PhD

CONTACT

02-82241; antonio.messina@humanitas.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2021
• First Posted: December 15, 2021
• Study Start: January 1, 2022
• Primary Completion: January 1, 2023
• Study Completion: January 1, 2023
• Last Updated: December 15, 2021

Record last verified: 2021-12

Locations

IT (1)