Clinical trial NCT02640846: Effects of Levosimendan, Milrinone and Norepinephrine on Left and Right Ventricular Function in Septic Shock
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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Septic Shock
Cardiomyopathy
Keywords: Levosimendan
Milrinone
Myocardial strain
Septic cardiomyopathy
Norepinephrine
Lead sponsor: Sahlgrenska University Hospital
Sponsor class: OTHER
First posted: 2015-12-29
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Changes in LV systolic strain
timeFrame: 1.5 hours
measure: Changes in RV systolic strain
timeFrame: 1.5 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Central intensivvårdsavdelning Sahlgrenska University Hospital
state: Västra Götaland
Study officials:
affiliation: Sahlgrenska Academy, dep of clinical science
name: Sven-Erik Ricksten, Professor
role: STUDY_CHAIR
References: