Levosimendan improves renal outcome in cardiac surgery: a randomized trial.
OBJECTIVE
The effect of levosimendan on renal function in patients with low ejection fraction undergoing mitral valve surgery was investigated.


METHODS
A prospective, double-blinded, randomized clinical trial.


METHODS
Tertiary teaching and research hospital.


METHODS
Of a total of 147 patients, 128 patients completed the study. In the levosimendan group (n = 64), levosimendan was administered in addition to standard inotropic support; whereas, in the control group (n = 64), only standard inotropic support was given.


METHODS
In the levosimendan group, a loading dose of levosimendan (6 μg/kg) was administered after removal of the aortic cross-clamp, followed by an infusion (0.1 μg/kg/min) in addition to standard inotropic therapy for 24 hours. In the control group, only standard inotropic therapy was administered. Preoperative characteristics, serum creatinine (sCr) levels, and estimated glomerular filtration rate (eGFR) were determined preoperatively, on postoperative days 1, 3, and 10. Independent risk factors for renal replacement therapy (RRT) requirement were investigated with stepwise multivariate logistic regression analysis.


RESULTS
The primary endpoint was the effect of levosimendan on postoperative renal clearance (sCr and eGFR). The secondary endpoint was the effect of levosimendan on clinical outcomes (length of intensive care unit and hospital stays, need for RRT). Preoperative characteristics and eGFR were similar between the groups (p>0.05). On postoperative days 1 and 3, sCr values were lower and eGFR values were higher in the levosimendan group in comparison with the control group (p = 0.0001, p = 0.009, respectively). Six patients (9.4%) in the levosimendan group and 10 patients (15.6%) in the control group required RRT therapy (p = 0.284). Independent risk factors for need of RRT include preoperative sCr value between 1.2 to 2.09 mg/dL and≥2.1 mg/dL (p< 0.05).


CONCLUSIONS
Perioperative treatment with levosimendan in addition to standard inotropic therapy in patients with a low ejection fraction undergoing mitral valve surgery improved immediate postoperative renal function and reduced need for RRT.
Anesthesiology and Reanimation Clinic, Kartal Kosuyolu High Speciality Training and Research Hospital, Istanbul, Turkey. Electronic address: draysebay@yahoo.com.
Ayse
A
Baysal
Cardiovascular Surgery Clinic, Kartal Kosuyolu High Speciality Training and Research Hospital, Istanbul, Turkey.
Mehmet
M
Yanartas
Anesthesiology and Reanimation Clinic, Adiyaman University Training and Research Hospital, Adiyaman, Turkey.
Mevlut
M
Dogukan
Clinic of Anesthesiology and Reanimation, Sanliurfa Training and Research Hospital, Sanliurfa, Turkey.
Narin
N
Gundogus
Anesthesiology and Reanimation Clinic, Kartal Kosuyolu High Speciality Training and Research Hospital, Istanbul, Turkey.
Tuncer
T
Kocak
Cardiovascular Surgery Clinic, Kartal Kosuyolu High Speciality Training and Research Hospital, Istanbul, Turkey.
Cengiz
C
Koksal
D000328:Adult; D000368:Aged; D006348:Cardiac Surgical Procedures / Q000009:adverse effects* / Q000379:methods; D003404:Creatinine / Q000097:blood; D004311:Double-Blind Method; D005260:Female; D005919:Glomerular Filtration Rate; D006801:Humans; D006835:Hydrazones / Q000627:therapeutic use*; D007674:Kidney Diseases / Q000517:prevention & control*; D008297:Male; D008875:Middle Aged; D011183:Postoperative Complications / Q000517:prevention & control*; D011446:Prospective Studies; D011724:Pyridazines / Q000627:therapeutic use*; D017582:Renal Replacement Therapy; D000077464:Simendan; D013318:Stroke Volume; D016896:Treatment Outcome; D014665:Vasodilator Agents / Q000627:therapeutic use*
D006835:Hydrazones; D011724:Pyridazines; D014665:Vasodilator Agents; D000077464:Simendan; D003404:Creatinine
cardiopulmonary bypass; ejection fraction; estimated glomerular filtration rate; levosimendan; mitral valve surgery; serum creatinine