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

Sahlgrenska University Hospital

Status and phase: Unknown; Phase 4

Conditions: Cardiomyopathy; Septic Shock

Treatments: Drug: Milrinone; Drug: Norepinephrine; Drug: Levosimendan

Study type: Interventional

Funder types: Other

Identifiers

NCT02640846

K050711

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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30 participants in 3 patient groups

Norepinephrine

Active Comparator group

Description:

Doser

Treatment:

Drug: Norepinephrine

Milrinone

Active Comparator group

Description:

Doser

Treatment:

Drug: Milrinone

Levosimendan

Active Comparator group

Description:

Doser

Treatment:

Drug: Levosimendan