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Global Longitudinal Strain Assessment in Cardiogenic Shock During Sepsis

NCT04141410 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 35

Last updated 2019-10-28

No results posted yet for this study

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

Interventions

DRUG

Levosimendan

Use of Levosimendan in cardiogenic shock during sepsis

DEVICE

Echocardiography

Use of global longitudinal strain in cardiogenic shock during sepsis

Sponsors & Collaborators

  • Azienda USL Toscana Centro

    lead OTHER

Principal Investigators

  • Iacopo Cappellini, MD · Azienda USL Toscana Centro

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-21
Primary Completion
2020-10-21
Completion
2021-01-21
FDA Drug
Yes

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04141410 on ClinicalTrials.gov