Comparison of the Administration of Levosimendan and Placebo in the Preparation of Critical Patients for Heart Surgery

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
ClinicalTrials.gov Identifier:
NCT01595737
First received: May 7, 2012
Last updated: January 21, 2013
Last verified: May 2012

May 7, 2012
January 21, 2013
February 2011
February 2013   (final data collection date for primary outcome measure)
  • Mortality [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    Rate of mortality
  • Morbidity [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    Rate of morbidity
Same as current
Complete list of historical versions of study NCT01595737 on ClinicalTrials.gov Archive Site
  • Dose of inotropic drugs used [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    Requirements for inotropic drugs
  • Dose of vasoactive drugs used [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    Requirements for vasoactive drugs
Doses of inotropic and vasoactive drugs used [ Time Frame: 30 days ] [ Designated as safety issue: No ]
Requirements for inotropic and vasoactive drugs
Not Provided
Not Provided
 
Comparison of the Administration of Levosimendan and Placebo in the Preparation of Critical Patients for Heart Surgery
Comparison of the Administration of Levosimendan and Placebo in the Preparation of Critical Patients for Heart Surgery

This study aims to examine the efficacy of levosimendan in terms of reducing postoperative mortality and severe morbidity in patients undergoing non-emergent surgery for coronary revascularisation with or without ischaemic mitral regurgitation and who may or may not require repair or replacement of the mitral valve and have a LVEF < 35%.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Cardiac Surgery
  • Drug: Levosimendan
    Levosimendan perfusion for 12 hours before surgery by a single route, at a dosage of 0.1µg/kg/min without receiving the loading dose.
  • Drug: Placebo
    Placebo group patients will receive a perfusion of 5% glucose solution. This clear solution, free of visible particles, will have 0.4mg of riboflavin sodium phosphate, 100mg of anhydrous alcohol and water for injection up to 1ml added to it. This solution will be calculated as a dose of 0.1µg/kg/min.
  • Experimental: Levosimendan
    Intervention: Drug: Levosimendan
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
30
January 2015
February 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male or female > 18 years and < 85 years.
  • LVEF ≤ 35%
  • Indication for elective surgery for coronary revascularisation, with or without mitral valve repair.
  • Freely choose to participate in trial and sign an informed consent

Exclusion Criteria:

  • The patient does not accept the protocol.
  • Allergy (hypersensitivity) to levosimendan, any of its components or to riboflavin.
  • Severe hypotension or severe tachycardia prior to entering study.
  • Significant mechanical obstruction affecting ventricular filling and/or emptying.
  • History of Torsades.
  • Requirement for inotropic or vasoactive drugs or any type of mechanical assistance for 48 hours prior to surgery.
  • Onset of angina or acute myocardial infarction within 48 hours prior to surgery, or cardiogenic shock.
  • Surgery needs that are different from those planned.
  • Chronic or severe kidney failure requiring haemodialysis or peritoneal dialysis or creatinine clearance values below 30ml/min or presence of nephrotic syndrome.
  • Liver failure with transaminases 4 times above the normal maximum value.
  • The patient must undergo a concurrently scheduled surgery, such as for a valve other than the mitral.
  • When a screening cannot be performed at least during the 24 hours before surgery.
  • Uncontrolled diabetes mellitus (blood glucose > 24mmol/l or 432mg/dl).
  • History of any disease over the last five years that may compromise the patient's life, other than their heart disease.
  • The patient is currently abusing alcohol or toxic substances.
  • Presence of any other medical or psychiatric condition that the researcher believes makes a candidate ineligible for the study.
  • Women with childbearing potential who are not using an effective contraception method.
  • Participation in the last 30 days in any other study with either experimental drugs or devices.
  • Body Mass Index (BMI) greater than 35.
  • Administration of levosimendan in the last 30 days.
Both
18 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT01595737
ACA-SPAI-2008-20
Yes
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Not Provided
Not Provided
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
May 2012

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