Prophylactic Administration of Levosimendan in Patients Undergoing Coronary Surgery
Primary Purpose
Coronary Artery Disease
Status
Completed
Phase
Phase 4
Locations
Greece
Study Type
Interventional
Intervention
Levosimendan infusion
Placebo infusion
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Artery Disease focused on measuring coronary artery disease, levosimendan, coronary artery bypass grafting, cardiac surgery
Eligibility Criteria
Inclusion Criteria:
- coronary artery disease which warrants myocardial revascularization with coronary artery bypass grafting according to current guidelines
- age < 79 years old
- left ventricular ejection fraction <= 40%
- informed patient's consent
Exclusion Criteria:
- age < 18 years old
- emergency surgery
- medical history of acute myocardial infarction with ST elevation (STEMI) less than 14 days old
- any severe comorbidity which increases the perioperative risk (i.e. neoplasia, rheumatoid arthritis, chronic obstructive pulmonary disease)
- need for valvular replacement surgery
- redo surgery
- serum creatinine > 2 mg/dl
- history of malignant cardiac arrhythmias
Sites / Locations
- Department of Cardiothoracic Surgery, AHEPA University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Levosimendan
Placebo group
Arm Description
Patients treated with prophylactic administration of levosimendan
Patients managed with placebo administration
Outcomes
Primary Outcome Measures
Left ventricular function
Left ventricular function as assessed by transthoracic or transesophageal echocardiography on the seventh postoperative day
Secondary Outcome Measures
Perioperative mortality
Need for intraaortic balloon pump
Inotropic support
Need for high inotropic support
Total ICU stay
Total length of hospital stay
Time on mechanical ventilation
Major adverse cardiovascular events
Perioperative myocardial infarction, stroke, need for revascularization)
Morbidity
Full Information
NCT ID
NCT01318460
First Posted
March 17, 2011
Last Updated
May 4, 2019
Sponsor
AHEPA University Hospital
Collaborators
Orion Corporation, Orion Pharma
1. Study Identification
Unique Protocol Identification Number
NCT01318460
Brief Title
Prophylactic Administration of Levosimendan in Patients Undergoing Coronary Surgery
Official Title
Prophylactic Administration of Levosimendan in Patients With Impaired Left Ventricular Function Undergoing Coronary Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
March 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
AHEPA University Hospital
Collaborators
Orion Corporation, Orion Pharma
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The present pilot study aims to investigate the effectiveness of the preoperative infusion of levosimendan in patients with impaired left ventricular function undergoing coronary artery bypass grafting.
Detailed Description
Myocardial revascularization in patients with impaired left ventricular function remains a serious problem in cardiac surgery. Despite the recent developments with the use of new surgical techniques (mini-extracorporeal circulation, off pump surgery) the perioperative morbidity and mortality are relatively high. Therapeutic solutions with the use of inotropic drugs, as adrenergic agonists and phosphodiesterase inhibitors, have offered important improvement to the hemodynamic status of these patients, but they have not considerably decreased mortality. These drugs owe their positive inotropic action to the increase of intracellular calcium and thereafter they improve the myocardial function.
Levosimendan (SIMDAX) is a new calcium sensitizer which increases the myocardial contractility without particular promotion of the intracellular calcium accumulation. Contemporary experimental and clinical data demonstrated the effectiveness of this drug in the reduction of surgical mortality to the patients with low left ventricular ejection fraction (LVEF) who undergo coronary artery bypass grafting (CABG).
This is an original prospective randomized controlled study focused on the preoperative use of this drug in patients with impaired left ventricular function which is associated with a high operative risk (i.e. EuroSCORE). Perioperative myocardial stunning is particularly evident in this cohort of patients. Prophylactic administration of levosimendan the day before the operation could be translated in improved myocardial performance intraoperatively and during the early postoperative period.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
coronary artery disease, levosimendan, coronary artery bypass grafting, cardiac surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Levosimendan
Arm Type
Active Comparator
Arm Description
Patients treated with prophylactic administration of levosimendan
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
Patients managed with placebo administration
Intervention Type
Drug
Intervention Name(s)
Levosimendan infusion
Intervention Description
Prophylactic 24h infusion of levosimendan at a dose of 0.1 mg/kg/min
Intervention Type
Drug
Intervention Name(s)
Placebo infusion
Intervention Description
Twenty-four hour administration of placebo
Primary Outcome Measure Information:
Title
Left ventricular function
Description
Left ventricular function as assessed by transthoracic or transesophageal echocardiography on the seventh postoperative day
Time Frame
Seventh postoperative day
Secondary Outcome Measure Information:
Title
Perioperative mortality
Time Frame
30 days postoperatively
Title
Need for intraaortic balloon pump
Time Frame
1st-7th postoperative day
Title
Inotropic support
Description
Need for high inotropic support
Time Frame
1st-7th postoperative day
Title
Total ICU stay
Time Frame
1st-7th postoperative day
Title
Total length of hospital stay
Time Frame
1st-7th postoperative day
Title
Time on mechanical ventilation
Time Frame
1st-7th postoperative day
Title
Major adverse cardiovascular events
Description
Perioperative myocardial infarction, stroke, need for revascularization)
Time Frame
1st-7th postoperative day
Title
Morbidity
Time Frame
1st-7th postoperative day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
coronary artery disease which warrants myocardial revascularization with coronary artery bypass grafting according to current guidelines
age < 79 years old
left ventricular ejection fraction <= 40%
informed patient's consent
Exclusion Criteria:
age < 18 years old
emergency surgery
medical history of acute myocardial infarction with ST elevation (STEMI) less than 14 days old
any severe comorbidity which increases the perioperative risk (i.e. neoplasia, rheumatoid arthritis, chronic obstructive pulmonary disease)
need for valvular replacement surgery
redo surgery
serum creatinine > 2 mg/dl
history of malignant cardiac arrhythmias
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kyriakos Anastasiadis, MD, FETCS
Organizational Affiliation
AHEPA University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Christos Papakonstantinou, MD
Organizational Affiliation
AHEPA University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Cardiothoracic Surgery, AHEPA University Hospital
City
Thessaloniki
ZIP/Postal Code
546 36
Country
Greece
12. IPD Sharing Statement
Citations:
PubMed Identifier
17377079
Citation
De Hert SG, Lorsomradee S, Cromheecke S, Van der Linden PJ. The effects of levosimendan in cardiac surgery patients with poor left ventricular function. Anesth Analg. 2007 Apr;104(4):766-73. doi: 10.1213/01.ane.0000256863.92050.d3. Erratum In: Anesth Analg. 2007 Jun;104(6):1544. Dosage error in article text.
Results Reference
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PubMed Identifier
17702589
Citation
Tasouli A, Papadopoulos K, Antoniou T, Kriaras I, Stavridis G, Degiannis D, Geroulanos S. Efficacy and safety of perioperative infusion of levosimendan in patients with compromised cardiac function undergoing open-heart surgery: importance of early use. Eur J Cardiothorac Surg. 2007 Oct;32(4):629-33. doi: 10.1016/j.ejcts.2007.07.010. Epub 2007 Aug 15. Erratum In: Eur J Cardiothorac Surg. 2008 Mar;33(3):521.
Results Reference
background
PubMed Identifier
19592266
Citation
Kolseth SM, Nordhaug DO, Stenseth R, Sellevold O, Kirkeby-Garstad I, Wahba A. Prophylactic treatment with levosimendan: a retrospective matched-control study of patients with reduced left ventricular function. Eur J Cardiothorac Surg. 2009 Dec;36(6):1024-30. doi: 10.1016/j.ejcts.2009.05.001. Epub 2009 Jul 9.
Results Reference
background
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Prophylactic Administration of Levosimendan in Patients Undergoing Coronary Surgery
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