Can Tolvaptan Protect Renal Function in the Early Postoperative Period of Cardiac Surgery?　― Results of a Single-Center Randomized Controlled Study ―

Abstract

Background: Oral administration of tolvaptan, a vasopressin V2 receptor antagonist, significantly reduces deterioration of renal function, which has recently been highlighted as an exacerbating factor for adverse events in patients with acute heart failure. In the present study we tested the hypothesis that concomitant administration of tolvaptan with a conventional diuretic is beneficial for perioperative body fluid management in patients who have undergone cardiac surgery. Methods and Results:In all, 280 patients who underwent cardiac surgery were prospectively randomized to concomitant treatment with tolvaptan and a conventional diuretic (tolvaptan group; 147 patients) or treatment with a conventional diuretic alone (control group; 133 patients). Groups were compared in terms of the time required to restore preoperative body weight and the incidence of worsening renal function (WRF), defined as an increase in the serum creatinine level ≥0.3 mg/dL. The time required to restore preoperative body weight was significantly shorter in the tolvaptan than control group (mean [±SD] 3.97±1.95 vs. 5.02±2.83 days, respectively; P<0.001). The incidence of WRF was significantly lower in the tolvaptan than control group (n=11 [7.5%] vs. n=25 [18.8%], respectively; P=0.011). Conclusions:Administration of tolvaptan with conventional diuretics in the early postoperative period after cardiac surgery could be beneficial in maintaining urine output without affecting renal function and may thus help avoid WRF.

Efficacy of tolvaptan for fluid management after cardiovascular surgery: A systematic review and meta‑analysis of randomized control trials

“…5). Descriptive analysis of results from three studies indicated no significant difference in mean serum potassium levels between the two study groups (2,16,17).…”

“…One study was conducted on pediatric patients ( 15 ), and another on patients with chronic kidney disease ( 8 ). Finally, four studies were included in this systematic review and meta-analysis ( 2 , 16-18 ). Details of the included studies are presented in Table I .…”

“…However, none of the four studies reported extreme hypernatremia with tolvaptan. The exception was Kishimoto et al (2) who reported sodium levels of >147 mEq/l in 5 patients with tolvaptan therapy, which returned to normal after discontinuation of the drug.…”

“…Any cardiac procedure involving or not involving cardiopulmonary bypass can cause a significant increase in total body water due to high fluid load (1). The surgical stress of the procedure and the use of extra-corporeal circulation also contribute to increased body water levels (2). Management of such patients has been primarily dependent on the use of loop diuretics such as furosemide, which is the drug of choice.…”

Tolvaptan—New Opportunity in Fluid Management After Cardiopulmonary Bypass

“…The inclusion of 1 pediatric study and 1 study on chronic kidney disease further contributes to heterogeneity in the overall population. With the exception of 1 study, 12 sample sizes of the included studies were low. However, small studies should be included in meta-analyses to avoid publication bias.…”