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

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ClinicalTrials.gov Identifier: NCT02640846
Recruitment Status : Unknown
Verified December 2015 by Keti Dalla, Sahlgrenska University Hospital, Sweden.
Recruitment status was:  Active, not recruiting
First Posted : December 29, 2015
Last Update Posted : November 29, 2018
Sponsor:
Information provided by (Responsible Party):
Keti Dalla, 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.

Condition or disease Intervention/treatment Phase
Septic Shock Cardiomyopathy Drug: Norepinephrine Drug: Milrinone Drug: Levosimendan Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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 Start Date : December 2015
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : January 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cardiomyopathy Shock

Arm Intervention/treatment
Active Comparator: Norepinephrine
Doser
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.

Active Comparator: Milrinone
Doser
Drug: Milrinone
Corotrope will be given and after 30 minutes of treatment the cardiac function will be assessed with echocardiography and systemic hemodynamics.
Other Name: Corotrope

Active Comparator: Levosimendan
Doser
Drug: Levosimendan
Levosimendan will be given and after 30 minutes of treatment the cardiac function will be assessed with echocardiography and systemic hemodynamics.
Other Name: Simdax




Primary Outcome Measures :
  1. Changes in LV systolic strain [ Time Frame: 1.5 hours ]
    Changes in LV systolic function (global strain) will be assessed by 2D speckle tracking echocardiography

  2. Changes in RV systolic strain [ Time Frame: 1.5 hours ]
    Changes in RV systolic function (RV free wall strain) will be assessed by 2D speckle tracking echocardiography



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02640846


Locations
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Sweden
Central intensivvårdsavdelning Sahlgrenska University Hospital
Gothenburg, Västra Götaland, Sweden, 41345
Sponsors and Collaborators
Sahlgrenska University Hospital, Sweden
Investigators
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Study Chair: Sven-Erik Ricksten, Professor Sahlgrenska Academy, dep of clinical science

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Responsible Party: Keti Dalla, MD, Sahlgrenska University Hospital, Sweden
ClinicalTrials.gov Identifier: NCT02640846     History of Changes
Other Study ID Numbers: K050711
First Posted: December 29, 2015    Key Record Dates
Last Update Posted: November 29, 2018
Last Verified: December 2015
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Keti Dalla, Sahlgrenska University Hospital, Sweden:
Levosimendan
Milrinone
Myocardial strain
Septic cardiomyopathy
Norepinephrine

Additional relevant MeSH terms:
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Shock
Cardiomyopathies
Shock, Septic
Pathologic Processes
Heart Diseases
Cardiovascular Diseases
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Norepinephrine
Simendan
Milrinone
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Vasoconstrictor Agents
Cardiotonic Agents
Vasodilator Agents
Phosphodiesterase 3 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Protective Agents
Platelet Aggregation Inhibitors