Clinical Trial: The Effects of Levosimendan During Mitral Valve Surgery

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: The Effects of Levosimendan on Renal Function in Patients With Low Ejection Fraction Undergoing Mitral Valve Surgery.

Brief 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.

Detailed Summary:

Introduction:

The coronary and peripheral vasodilatory properties of levosimendan has recently been investigated in patients with heart failure. It is considered as a promising alternative to conventional inotropic agents for patients with low LVEF. However, the effects of levosimendan on renal functions in patients undergoing open heart surgeries with CPB are not well studied in randomized clinical trials.

The primary goal of our study was to investigate the effects of levosimendan on 1- renal function by evaluation of serum creatinine (mg/dL) values and calculated estimated glomerular filtration(eGFR)(ml/min/1.73 m2) rates.

Our secondary goal was to determine clinical outcomes including;

1-need for renal replacement therapy (RRT) in patients with low ejection fraction undergoing mitral valve repair or replacement surgery with cardiopulmonary bypass (CPB).

Inclusion and exclusion criterions include as listed below. Patients included into the study had a diagnosis of mitral valve insufficiency with or without coronary artery disease and a left ventricular ejection fraction (LVEF) of ≤ 45 %.

Exclusion criteria were unstable angina, diabetes mellitus treated with insulin, clinical findings of acute or chronic renal failure (serum creatinine (sCr)> 1.5 mg/dL), severe hepatic disease (alanine aminotransferase or aspartate aminotransferase > 100 U litre/L), severe chronic obstructive pulmonary disease (forced expired volume in 1 s < 50 % of predicted or < 2.0 litre), a history of prior coronary artery bypass graft (CABG) surgery or myocardial infarction (MI) within the previous month, emergent operations, patients
Sponsor: Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital

Current Primary Outcome: The effects of levosimendan on renal function in patients with low ejection fraction undergoing mitral valve surgery. [ Time Frame: Between the time period of July 1, 2009 to January 30, 2013 participants will be followed for the duration of hospital stay, an expected average of 10 days. ]

The effects of levosimendan on postoperative renal function measured by serum creatinine (sCr) levels and estimated glomerular filtration rate (eGFR).


Original Primary Outcome: Same as current

Current Secondary Outcome: The effects of levosimendan on renal function in patients with low ejection fraction undergoing mitral valve surgery. [ Time Frame: Between the time period of July 1, 2009 to January 30, 2013 participants will be followed for the duration of hospital stay, an expected average of 10 days. ]

Secondary end points were the effects of levosimendan on clinical outcomes which include the pre- and perioperative prognostic risk factors such as; 1-aortic cross-clamp time, 2- cardiopulmonary bypass time, 3- the use of inotropic support, 4-intra-aortic balloon pump, 5- prolonged mechanical ventilation, 6-development of pneumonia, 7- Perioperative myocardial infarction, 8- cerebrovascular event (stroke, transient ischemic attack), 9- atrial fibrillation and other rhythm disturbances, 10- need for renal replacement therapy (RRT), 11-reoperation secondary to bleeding, 12-intensive care unit stay and 13- hospital stay.


Original Secondary Outcome: Same as current

Information By: Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital

Dates:
Date Received: May 24, 2013
Date Started: July 2009
Date Completion:
Last Updated: October 23, 2013
Last Verified: September 2013