Global Longitudinal Strain Assessment in Cardiogenic Shock During Sepsis

NCT04141410 | Unknown DMC FDA Drug

• 1 other identifier: 13875 17/18 PO
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

Cardiogenic shock is a condition of low cardiac output that represents the end of a progressive deterioration of cardiac function. The main cause is ischemic heart disease but there are several causes of non-ischemic nature including sepsis. Sepsis is characterized by a picture of organ dysfunction caused by an altered response of the body to an infection. Its most serious form is septic shock, defined as a picture of sepsis in which the underlying abnormalities in the cardiovascular system and cellular metabolism are such as to increase mortality. An organ failure correlates directly with the function of others and this interdependence is especially evident when a cardiovascular failure is established. 3 Cardiac dysfunction in sepsis can be defined as that of a syndrome characterized by low cardiac output not related to myocardial ischemia. The use of levosimendan in cardiogenic shock during sepsis was first described in a 2005 case report. Since then there have been small studies and other case reports that have shown improvements in right and left ventricular contractility, ventricular coupling, cardiopulmonary performance, global oxygen transport, renal and splanchnic perfusion when compared to dobutamine and placebo. Other beneficial effects of this drug have emerged, including an anti-inflammatory, antioxidant and antiapoptotic action with a possible protection from ischemia-reperfusion damage. The present study aims to evaluate the correct use of levosimendan, after the occurrence of cardiogenic shock on a low cardiac index has been ascertained, with the aim of weaning from inotropic drugs in infusion.

Conditions

Sepsis; Septic Shock; Cardiogenic Shock

Keywords

Sepsis; Septic Shock; Cardiogenic Shock; Speckle Tracking Echocardiography; Levosimendan

Outcome Measures

Primary Outcomes (1)

• Global Longitudinal Strain ≥ 15%

  Recovery of normal values of GLS ≥ 15% after infusion of dobutamine and levosimendan

  up to 1 week

Secondary Outcomes (1)

• Mortality

  1 year

Interventions

Levosimendan DRUG

Use of Levosimendan in cardiogenic shock during sepsis

Echocardiography DEVICE

Use of global longitudinal strain in cardiogenic shock during sepsis

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Eligible patients will be those admitted to the intensive care units of the hospital Santo Stefano in Prato with diagnosis of cardiogenic shock during sepsis and who will present the following criteria for inclusion.

You may qualify if:

• Informed Consent
• Age between 18 and 80 years old
• Diagnosis di Sepsis following criteria of Third National Consensus Definitions for Sepsis and Septic Shock 2
• Diagnosis of Cardiogenic Shock with Heart Index \< 2.5 L/min/m2 calculated by PiCCO thermodilution method and/or Diagnosis of Stroke Cardiogenic Shock Volume Index \< 30 mL/beat/m2 calculated by PiCCO thermodilution method
• Patients applying for treatment with dobutamine and levosimendan according to the procedure laid down in current clinical practice at the Centre
• Ventricle coupling Arterial Ea/Ees \> 1 via IElastance application

You may not qualify if:

• Age \< 18 years and \> 80 years
• Pre-existing diagnosis of heart failure at a reduced or preserved ejection fraction
• History of valvular heart disease or valve replacement and/or PM implant
• Severe pulmonary hypertension and chronic pulmonary heart
• Poor acoustic windows for echocardiography
• History of hypersensitivity or allergy to levosimendan

Sponsors & Collaborators

• Azienda USL Toscana Centro: lead

Study Sites (1)

Ospedale Santo Stefano

Prato, FI, 59100, Italy

RECRUITING

Related Publications (1)

• Cappellini I, Melai A, Zamidei L, Parise M, Cipani S, Consales G. Levosimendan and Global Longitudinal Strain Assessment in Sepsis (GLASSES 1): a study protocol for an observational study. BMJ Open. 2020 Sep 25;10(9):e037188. doi: 10.1136/bmjopen-2020-037188.

  PMID: 32978191 DERIVED

MeSH Terms

Conditions

Sepsis; Shock, Septic; Shock, Cardiogenic

Interventions

Simendan; Echocardiography

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock; Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Necrosis

Intervention Hierarchy (Ancestors)

Hydrazones; Hydrazines; Organic Chemicals; Pyridazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Cardiac Imaging Techniques; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Ultrasonography; Heart Function Tests; Diagnostic Techniques, Cardiovascular

Study Officials

• Iacopo Cappellini, MD

  Azienda USL Toscana Centro

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Iacopo Cappellini, MD

CONTACT

+393398921412; jacopocappellini@gmail.com

Iacopo Cappellini

CONTACT

+393398921412; jacopocappellini@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 24, 2019
• First Posted: October 28, 2019
• Study Start: October 21, 2019
• Primary Completion: October 21, 2020
• Study Completion: January 21, 2021
• Last Updated: October 28, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be available for 1 year from October 2019

Locations

IT (1)