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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-31

Study Completion Date

2019-01-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Septic Shock Cardiomyopathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Norepinephrine

Doser

Group Type ACTIVE_COMPARATOR

Norepinephrine

Intervention Type DRUG

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

Doser

Group Type ACTIVE_COMPARATOR

Milrinone

Intervention Type DRUG

Corotrope will be given and after 30 minutes of treatment the cardiac function will be assessed with echocardiography and systemic hemodynamics.

Levosimendan

Doser

Group Type ACTIVE_COMPARATOR

Levosimendan

Intervention Type DRUG

Levosimendan will be given and after 30 minutes of treatment the cardiac function will be assessed with echocardiography and systemic hemodynamics.

Interventions

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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.

Intervention Type DRUG

Milrinone

Corotrope will be given and after 30 minutes of treatment the cardiac function will be assessed with echocardiography and systemic hemodynamics.

Intervention Type DRUG

Levosimendan

Levosimendan will be given and after 30 minutes of treatment the cardiac function will be assessed with echocardiography and systemic hemodynamics.

Intervention Type DRUG

Other Intervention Names

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Corotrope Simdax

Eligibility Criteria

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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%.