The Effects of Levosimendan During Mitral Valve Surgery

• Status: Completed
• Trial end date: 2013-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The effects of levosimendan on renal function in patients with low ejection fraction undergoing mitral valve surgery will be investigated in a prospective, double-blinded, randomized clinical trial using serum creatinine (sCr)milligram in deciliter (mg/dL) values, calculated estimated glomerular filtration(eGFR)(ml/min/1.73 m2) rates and perioperative clinical follow-up parameters.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital
• Treatments: Dobutamine; Simendan

Criteria

Inclusion Criteria:

• diagnosis of mitral valve insufficiency with or without coronary artery disease and a LVEF of ≤ 45 %.

Exclusion criteria:

• unstable angina,

• diabetes mellitus treated with insulin, clinical findings of acute or chronic renal failure (sCr > 1.5 mg dL-1),

• severe hepatic disease (alanine aminotransferase or aspartate aminotransferase > 100 U litre L-1),

• severe chronic obstructive pulmonary disease (forced expired volume in 1 s < 50 % of predicted or < 2.0 litre),

• a history of prior CABG surgery or myocardial infarction (MI) within the previous month,

• emergent operations,

• patients on inotropic support before operation,

• aortic valvular disease, and

• infective endocarditis.