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

Primary Purpose

Septic Shock, Cardiomyopathy

Status
Unknown status
Phase
Phase 4
Locations
Sweden
Study Type
Interventional
Intervention
Norepinephrine
Milrinone
Levosimendan
Sponsored by
Sahlgrenska University Hospital, Sweden
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Septic Shock focused on measuring Levosimendan, Milrinone, Myocardial strain, Septic cardiomyopathy, Norepinephrine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Central intensivvårdsavdelning Sahlgrenska University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Norepinephrine

Milrinone

Levosimendan

Arm Description

Doser

Doser

Doser

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
December 6, 2015
Last Updated
November 27, 2018
Sponsor
Sahlgrenska University Hospital, Sweden
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1. Study Identification

Unique Protocol Identification Number
NCT02640846
Brief Title
Effects of Levosimendan, Milrinone and Norepinephrine on Left and Right Ventricular Function in Septic Shock
Acronym
SCLM
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

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Unknown status
Study Start Date
December 2015 (undefined)
Primary Completion Date
January 2019 (Anticipated)
Study Completion Date
January 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sahlgrenska University Hospital, Sweden

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Septic Shock, Cardiomyopathy
Keywords
Levosimendan, Milrinone, Myocardial strain, Septic cardiomyopathy, Norepinephrine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Norepinephrine
Arm Type
Active Comparator
Arm Description
Doser
Arm Title
Milrinone
Arm Type
Active Comparator
Arm Description
Doser
Arm Title
Levosimendan
Arm Type
Active Comparator
Arm Description
Doser
Intervention Type
Drug
Intervention Name(s)
Norepinephrine
Intervention Description
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
Intervention Name(s)
Milrinone
Other Intervention Name(s)
Corotrope
Intervention Description
Corotrope will be given and after 30 minutes of treatment the cardiac function will be assessed with echocardiography and systemic hemodynamics.
Intervention Type
Drug
Intervention Name(s)
Levosimendan
Other Intervention Name(s)
Simdax
Intervention Description
Levosimendan will be given and after 30 minutes of treatment the cardiac function will be assessed with echocardiography and systemic hemodynamics.
Primary Outcome Measure Information:
Title
Changes in LV systolic strain
Description
Changes in LV systolic function (global strain) will be assessed by 2D speckle tracking echocardiography
Time Frame
1.5 hours
Title
Changes in RV systolic strain
Description
Changes in RV systolic function (RV free wall strain) will be assessed by 2D speckle tracking echocardiography
Time Frame
1.5 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sven-Erik Ricksten, Professor
Organizational Affiliation
Sahlgrenska Academy, dep of clinical science
Official's Role
Study Chair
Facility Information:
Facility Name
Central intensivvårdsavdelning Sahlgrenska University Hospital
City
Gothenburg
State/Province
Västra Götaland
ZIP/Postal Code
41345
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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