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Randomized Controlled Trial
Efficacy and Safety Evaluation of Tolvaptan on Management of Fluid Balance after Cardiovascular Surgery Using Cardiopulmonary Bypass.
- Yasuo Suehiro, Mitsuharu Hosono, Toshihiko Shibata, Yasuyuki Sasaki, Hidekazu Hirai, Atsushi Nakahira, Yuko Kubota, Daisuke Kaku, and Shigefumi Suehiro.
- Osaka City Med J. 2016 Dec 1; 62 (2): 111-119.
BackgroundTolvaptan is an orally administered selective vasopressin 2 receptor antagonist that promotes aquaresis. This study aimed to evaluate the efficacy and safety of tolvaptan on management of systemic fluid balance after cardiovascular surgery using cardiopulmonary bypass. .MethodsSixty-four patients who underwent cardiovascular surgery using cardiopulmonary bypass in our hospital were enrolled for this prospective, randomized study. These patients were divided into three groups: tolvaptan 15 mg+furosemide 20 mg (TH group), tolvaptan 7.5 mg+furosemide 20 mg (TI group), and furosemide 40 mg+spironolactone 50 mg (C group). The endpoint was safety management of systemic fluid balance using tolvaptan without renal dysfunction and electrolyte imbalance.ResultsThe mean daily urine output in the TH and TL groups (2656±767 and 2505 ±684 mL) was significantly higher than that in the C group (1956±494 mL, TH vs C: p<0.01 and TL vs C: p=0.03). The lowest serum sodium level during medication in the TH group (139.3 ±2.3 mEq/L) was significantly higher than that in the C group (137.1±2.9 mEq/L, p=0.03) The lowest serum osmolality during medication in the TH group was significantly higher than that in the C group (284.8 ±4.3 vs 279.5± 6.3 mOsm/kg, p<0.01). None had critical hypernatremia, hyperosm6lality, or renal dysfunction in any. of the groups.ConclusionsTolvaptan exerts, a strong diuretic effect compared with conventional diuretics (furosemide and spironolactone) during the postoperative period after an operation using cardiopulmonary bypass without adverse effects on electrolyte balance and renal function.
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