Mitral Valve Stenosis With Incompetence or Regurgitation Clinical Trial
Official title:
The Effects of Levosimendan on Renal Function in Patients With Low Ejection Fraction Undergoing Mitral Valve Surgery.
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.
Status | Completed |
Enrollment | 140 |
Est. completion date | September 2013 |
Est. primary completion date | January 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 30 Years to 80 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Turkey | Kartal Kosuyolu High Speciality Training and Research Hospital | Istanbul |
Lead Sponsor | Collaborator |
---|---|
Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital |
Turkey,
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. Erratum in: Anesth Analg. 2007 Jun;104(6):1544. Dosage error in — View Citation
Elahi MM, Lim MY, Joseph RN, Dhannapuneni RR, Spyt TJ. Early hemofiltration improves survival in post-cardiotomy patients with acute renal failure. Eur J Cardiothorac Surg. 2004 Nov;26(5):1027-31. — View Citation
García González MJ, Domínguez Rodríguez A. Pharmacologic treatment of heart failure due to ventricular dysfunction by myocardial stunning: potential role of levosimendan. Am J Cardiovasc Drugs. 2006;6(2):69-75. Review. — View Citation
Haase-Fielitz A, Bellomo R, Devarajan P, Story D, Matalanis G, Dragun D, Haase M. Novel and conventional serum biomarkers predicting acute kidney injury in adult cardiac surgery--a prospective cohort study. Crit Care Med. 2009 Feb;37(2):553-60. doi: 10.10 — View Citation
Hernández A, Miranda A, Parada A. [Levosimendan reduces mortality in cardiac surgery: a systematic review and meta-analysis]. Rev Esp Anestesiol Reanim. 2012 Jan;59(1):6-11. doi: 10.1016/j.redar.2012.02.001. Epub 2012 Mar 14. Review. Spanish. — View Citation
Mehta RL, Kellum JA, Shah SV, Molitoris BA, Ronco C, Warnock DG, Levin A; Acute Kidney Injury Network. Acute Kidney Injury Network: report of an initiative to improve outcomes in acute kidney injury. Crit Care. 2007;11(2):R31. — View Citation
Metra M, Nodari S, Parrinello G, Bordonali T, Bugatti S, Danesi R, Fontanella B, Lombardi C, Milani P, Verzura G, Cotter G, Dittrich H, Massie BM, Dei Cas L. Worsening renal function in patients hospitalised for acute heart failure: clinical implications — View Citation
Nieminen MS, Akkila J, Hasenfuss G, Kleber FX, Lehtonen LA, Mitrovic V, Nyquist O, Remme WJ. Hemodynamic and neurohumoral effects of continuous infusion of levosimendan in patients with congestive heart failure. J Am Coll Cardiol. 2000 Nov 15;36(6):1903-12. — View Citation
Severi L, Lappa A, Landoni G, Di Pirro L, Luzzi SJ, Caravetta P, Cipullo P, Menichetti A. Levosimendan versus intra-aortic balloon pump in high-risk cardiac surgery patients. J Cardiothorac Vasc Anesth. 2011 Aug;25(4):632-6. doi: 10.1053/j.jvca.2011.03.00 — View Citation
Yilmaz MB, Yalta K, Yontar C, Karadas F, Erdem A, Turgut OO, Yilmaz A, Tandogan I. Levosimendan improves renal function in patients with acute decompensated heart failure: comparison with dobutamine. Cardiovasc Drugs Ther. 2007 Dec;21(6):431-5. Epub 2007 Oct 20. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | The effects of levosimendan on renal function in patients with low ejection fraction undergoing mitral valve surgery | Hemodynamic measurements include; 1- Cardiac output, 2-cardiac index (CI), 3-mean arterial pressure (MAP), 4-heart rate (HR), were recorded just before the start of surgery, at the end of CPB, on admission to the ICU, and postoperatively at 6 and 24 h later in the ICU. Hemodynamic targets were as follows: MAP =70 mmHg, CI = 2.0 L/min/m2 without signs of poor peripheral perfusion (oliguria, acidosis). |
Between the time period of July 1, 2009 to January 30, 2013 all patients will be evaluated participants will be followed for the duration of hospital stay, an expected average of 10 days. | Yes |
Primary | The effects of levosimendan on renal function in patients with low ejection fraction undergoing mitral valve surgery. | The effects of levosimendan on postoperative renal function measured by serum creatinine (sCr) levels and estimated glomerular filtration rate (eGFR). | 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. | Yes |
Secondary | The effects of levosimendan on renal function in patients with low ejection fraction undergoing mitral valve surgery. | 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. | 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. | Yes |