Intracoronary Administration of Levosimendan in Cardiac Surgery Patients

This study is currently recruiting participants.
Verified April 2014 by Tampere University Hospital
Sponsor:
Information provided by (Responsible Party):
Tampere University Hospital
ClinicalTrials.gov Identifier:
NCT01500785
First received: December 22, 2011
Last updated: April 7, 2014
Last verified: April 2014

December 22, 2011
April 7, 2014
January 2012
December 2014   (final data collection date for primary outcome measure)
change in cardiac output [ Time Frame: from baseline to 15min after weaning from CPB ] [ Designated as safety issue: No ]
Our primary endpoint is a change in cardiac output 15 min after separation from cardiopulmonary bypass compared to the baseline (after induction of anesthesia).
change in cardiac output [ Time Frame: 3 hours ] [ Designated as safety issue: No ]
Our primary endpoint is a change in cardiac output 15 min after separation from cardiopulmonary bypass compared to the baseline (after induction of anesthesia).
Complete list of historical versions of study NCT01500785 on ClinicalTrials.gov Archive Site
  • EF [ Time Frame: from baseline to 5 min after sternal closure ] [ Designated as safety issue: No ]
    Secondary endpoint is a change in LV ejection fraction (EF) from baseline (after induction of anesthesia) to 5 min after sternal closure.
  • cTnT/CK-MB on the first postoperative morning. [ Time Frame: from baseline to 1st post. op. morning ] [ Designated as safety issue: No ]
    Secondary endpoint is a change in cTnT/CK-MB on the first postoperative morning.
  • EF [ Time Frame: 3 hours ] [ Designated as safety issue: No ]
    Secondary endpoints are a change in LV ejection fraction (EF) from baseline (after induction of anesthesia) to 5 min after sternal closure and cTnT/CK-MB on the first postoperative morning.
  • cTnT/CK-MB on the first postoperative morning. [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    Secondary endpoints are a change in LV ejection fraction (EF) from baseline (after induction of anesthesia) to 5 min after sternal closure and cTnT/CK-MB on the first postoperative morning.
Not Provided
Not Provided
 
Intracoronary Administration of Levosimendan in Cardiac Surgery Patients
Intracoronary Administration of Levosimendan in Cardiac Surgery Patients

Incomplete recovery from ischemia causes stunned myocardium. Ischemia may be due to coronary artery disease or aortic cross-clamping during surgery. Stunning leads to myocardial dysfunction. It has been suggested that the mechanism responsible for the contractile depression in stunned myocardium is a decreased sensitivity of the myofibrils to calcium. Levosimendan is a calcium sensitizer, which has been shown to improve the function of stunned myocardium without obvious impairment of diastolic function. Systemic vasodilation and need of vasoconstrictive medication is usually apparent after administration of levosimendan. Colucci et al have demonstrated that with intracoronary administration of milrinone, another inodilator, systemic vasodilation could be excluded. If this is true with levosimendan, it may be possible to improve left ventricular hypo/dyskinesia without afterload reduction by adding levosimendan into cardioplegia solution.

The investigators hypotize that levosimendan, delivered together with cardioplegia, can improve LV dysfunction after opening of aortic cross-clamp in patients undergoing aortic valve and coronary artery bypass operation. Our primary endpoint is a change in cardiac output 15 min after separation from cardiopulmonary bypass compared to the baseline. Secondary endpoints are a change in LV ejection fraction from baseline to 5 min after sternal closure and cTnT/CK-MB on the first postoperative morning.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Myocardial Stunning
  • Drug: levosimendan
    infusion; levosimendan (12 μg/kg) The study drug will be administered together with the induction of cardioplegia solution during five minutes (=once for each patient)
    Other Names:
    • Simdax (manufacturer: Orion Corporation)
    • CO1CX08
  • Drug: Vitamin B 12
    Infusion made of Glucos B.Braun 50 mg/ml infusion together with vitamin B12 which is used to colour the glucose infusion to look identical to Simdax infusion The placebo will be administered together with the induction of cardioplegia solution during five minutes (=once for each patient).
    Other Name: Soluvit (B05XC)
  • Active Comparator: levosimendan
    Intervention: Drug: levosimendan
  • Placebo Comparator: placebo
    Intervention: Drug: Vitamin B 12
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
December 2014
December 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • preoperative LVEF 40% or less
  • septal wall thickness more than 11mm
  • less than moderate aortic insufficiency
  • sinus rhythm before CPB

Exclusion Criteria:

  • oesophageal disease
  • known allergy to levosimendan or its metabolites or adjuvants.
Both
18 Years and older
No
Contact: Panu Virkkala, MD +358331165079 panu.virkkala@sydankeskus.fi
Finland
 
NCT01500785
HCA-2011-1-3, 2011-002643-10
No
Tampere University Hospital
Tampere University Hospital
Not Provided
Principal Investigator: Panu Virkkala, MD Heart Center Co. Tampere university hospital
Tampere University Hospital
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP