Effects of Levosimendan, Milrinone and Norepinephrine on Left and Right Ventricular Function in Septic Shock

Septic Shock Clinical Trial

— SCLM  

Official title:

Potential Differences Between Levosimendan and Milrinone on Myocardial and Hemodynamic Variables in Patients With Septic Cardiomyopathy. Effects of Norepinephrine on Right Ventricular Function in Patient With Septic Shock.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02640846
• Other study ID #: K050711
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: December 2015
• Est. completion date: January 2019

Study information

• Verified date: December 2015
• Source: Sahlgrenska University Hospital, Sweden
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to investigate the effects milrinon and levosimandan on n heart function in septic cardiomyopathy and how norepinephrine affects the left and right ventricular function in patients with septick shock using pulmonary artery catheter, conventional and strain echocardiography.

Description:

This is a prospective study where 30 patients with septic chock during the care in ICU, will be included. Patients with a history of previous heart disease are excluded from the study. Each patient is in need of norepinephrine infusion and on mechanical ventilation. Initially the mean arterial pressure (MAP) is randomly changed from 60 to 75 and then to 90 mmHg. Hemodynamic variables as blood pressure, cardiac output, pulmonary artery occlusion pressure (PAOP) will be registerd at each MAP-level, arterial line and pulmonary artery catheter (PAC) and the cardiac function will be assessed with conventional and strain echocardiography. Then, if the echocardiogram shows impaired LV-function will the patient be randomized to receive either Milrinone or Levosimendan. Hemodynamic variables as blood pressure, cardiac output, pulmonary artery occlusion pressure (PAOP) will be registered again, as well the cardiac function with conventional and strain echocardiography. Echocardiograms will be analysed for the determination of LV an RV strain. Potential differences between different levels of blood pressure as well as effects of Milrinone or Levosimendan on hemodynamic and echocardiographyc variables will be analysed.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: January 2019
• Est. primary completion date: January 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Septic shock.

• All patients will be resuscitated with fluids before the inclusion.

• Need of Norepinephrine infusion.

• Myocardial dysfunction in echocardiogram, either LVEF < 50% or Global Left Ventricular Systolic strain over -15%.

Exclusion Criteria:

• History of previous heart disease or pulmonary hypertension.

• Age < 18 years.

• Cardiac arrhythmia.

Related Conditions & MeSH terms

• Cardiomyopathies
• Cardiomyopathy
• Septic Shock
• Shock
• Shock, Septic

Intervention

Drug:
• Norepinephrine
Norepinephrine will be given to the patient due to septic shock. After the inclusion we will change the dose of Norepinephrine to achieve 3 different MAP-levels, 60 mmHg, 75 mmHg and 90 mmHg.
• Milrinone
Corotrope will be given and after 30 minutes of treatment the cardiac function will be assessed with echocardiography and systemic hemodynamics.
• Levosimendan
Levosimendan will be given and after 30 minutes of treatment the cardiac function will be assessed with echocardiography and systemic hemodynamics.

Locations

Country	Name	City	State
Sweden	Central intensivvårdsavdelning Sahlgrenska University Hospital	Gothenburg	Västra Götaland

Sponsors (1)

Lead Sponsor	Collaborator
Sahlgrenska University Hospital, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in LV systolic strain	Changes in LV systolic function (global strain) will be assessed by 2D speckle tracking echocardiography	1.5 hours
Primary	Changes in RV systolic strain	Changes in RV systolic function (RV free wall strain) will be assessed by 2D speckle tracking echocardiography	1.5 hours