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

Phase 4

• Conditions: Septic Shock; Cardiomyopathy
• Interventions: Drug: Norepinephrine; Drug: Levosimendan; Drug: Milrinone

• Registration Number: NCT02640846
• Lead Sponsor: Sahlgrenska University Hospital, Sweden

Brief 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.

Detailed 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.

Study Timeline

• Status Verified: 2015-12
• Study Start: 2015-12
• Study First Submitted: 2015-12-06
• Study First Submitted QC: 2015-12-22
• Study First Posted: 2015-12-29
• Last Update Submitted: 2018-11-27
• Last Update Posted: 2018-11-29
• Primary Completion: 2019-01
• Study Completion: 2019-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Norepinephrine	Norepinephrine	Doser
Levosimendan	Levosimendan	Doser
Milrinone	Milrinone	Doser

Primary Outcome Measures

Name	Time	Method
Changes in LV systolic strain	1.5 hours	Changes in LV systolic function (global strain) will be assessed by 2D speckle tracking echocardiography
Changes in RV systolic strain	1.5 hours	Changes in RV systolic function (RV free wall strain) will be assessed by 2D speckle tracking echocardiography

Trial Locations

Locations (1)

Central intensivvårdsavdelning Sahlgrenska University Hospital; 🇸🇪 Gothenburg, Västra Götaland, Sweden