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Journal Article
Randomized Controlled Trial
A Randomized Blinded Study of the Left Ventricular Myocardial Performance Index Comparing Epinephrine to Levosimendan following Cardiopulmonary Bypass.
PloS One 2015
BACKGROUND: The objective was to evaluate the effect of epinephrine and levosimendan on the left ventricle myocardial performance index in patients undergoing on-pump coronary artery by-pass grafting (CABG).
METHODS: In a double-blind, randomized clinical trial, 81 patients (age: 45-65 years) of both genders were randomly divided to receive either epinephrine at a dosage of 0.06 mcg.kg(1).min(-1) (epinephrine group, 39 patients) or levosimendan at 0.2 mcg.kg(1).min(-1) (levosimendan group, 42 patients) during the rewarming of cardiopulmonary by-pass (CPB). Hemodynamic data were collected 30 minutes after tracheal intubation, before chest open (pre-CPB) and 10 minutes after termination of protamine (post-CPB). As the primary outcome, we evaluated the left ventricle myocardial performance index by the Doppler echocardiography. The myocardial performance index is the sum of the isovolumetric contraction time and the isovolumetric relaxation time, divided by the ejection time. Secondary outcomes were systolic and diastolic evaluations of the left ventricle and postoperative troponin I and MB-CK levels.
RESULTS: Of the 81 patients allocated to the research, we excluded 2 patients in the epinephrine group and 6 patients in the levosimendan group because they didn't wean from CPB in the first attempt. There was no statistical difference between the groups in terms of patient characteristics, risk factors, or CPB time. The epinephrine group had a lower left ventricle myocardial performance index (p = 0.0013), higher cardiac index (p = 0.03), lower systemic vascular resistance index (p = 0.01), and higher heart rate (p = 0.04) than the levosimendan group at the post-CPB period. There were no differences between the groups in diastolic dysfunction. The epinephrine group showed higher incidence of weaning from CPB in the first attempt (95% vs 85%, p = 0.0001) when compared to the levosimendan group and the norepinephrine requirement was higher in the levosimenandan group than epinephrine group (16% vs. 47%; p = 0.005) in post-CPB period. Twenty-four hours after surgery, the plasma levels of troponin I (epinephrine group: 4.5 ± 5.7 vs. levosimendan group: 2.5 ± 3.2 g/dl; p = 0.09) and MB-CK (epinephrine group: 50.7 ± 31 vs. levosimendan group: 37 ± 17.6 g/dl; p = 0.08) were not significantly different between the two groups.
CONCLUSION: When compared to levosimendan, patients treated with epinephrine had a lower left ventricle myocardial performance index in the immediate post-CPB period, encouraging an efficient weaning from CPB in patients undergoing on-pump CABG.
TRIAL REGISTRATION: ClinicalTrials.gov NCT01616069.
METHODS: In a double-blind, randomized clinical trial, 81 patients (age: 45-65 years) of both genders were randomly divided to receive either epinephrine at a dosage of 0.06 mcg.kg(1).min(-1) (epinephrine group, 39 patients) or levosimendan at 0.2 mcg.kg(1).min(-1) (levosimendan group, 42 patients) during the rewarming of cardiopulmonary by-pass (CPB). Hemodynamic data were collected 30 minutes after tracheal intubation, before chest open (pre-CPB) and 10 minutes after termination of protamine (post-CPB). As the primary outcome, we evaluated the left ventricle myocardial performance index by the Doppler echocardiography. The myocardial performance index is the sum of the isovolumetric contraction time and the isovolumetric relaxation time, divided by the ejection time. Secondary outcomes were systolic and diastolic evaluations of the left ventricle and postoperative troponin I and MB-CK levels.
RESULTS: Of the 81 patients allocated to the research, we excluded 2 patients in the epinephrine group and 6 patients in the levosimendan group because they didn't wean from CPB in the first attempt. There was no statistical difference between the groups in terms of patient characteristics, risk factors, or CPB time. The epinephrine group had a lower left ventricle myocardial performance index (p = 0.0013), higher cardiac index (p = 0.03), lower systemic vascular resistance index (p = 0.01), and higher heart rate (p = 0.04) than the levosimendan group at the post-CPB period. There were no differences between the groups in diastolic dysfunction. The epinephrine group showed higher incidence of weaning from CPB in the first attempt (95% vs 85%, p = 0.0001) when compared to the levosimendan group and the norepinephrine requirement was higher in the levosimenandan group than epinephrine group (16% vs. 47%; p = 0.005) in post-CPB period. Twenty-four hours after surgery, the plasma levels of troponin I (epinephrine group: 4.5 ± 5.7 vs. levosimendan group: 2.5 ± 3.2 g/dl; p = 0.09) and MB-CK (epinephrine group: 50.7 ± 31 vs. levosimendan group: 37 ± 17.6 g/dl; p = 0.08) were not significantly different between the two groups.
CONCLUSION: When compared to levosimendan, patients treated with epinephrine had a lower left ventricle myocardial performance index in the immediate post-CPB period, encouraging an efficient weaning from CPB in patients undergoing on-pump CABG.
TRIAL REGISTRATION: ClinicalTrials.gov NCT01616069.
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