Randomized Controlled Trial Comparing the Efficacy of Terlipressin and Albumin with a Combination of Concurrent Dopamine, Furosemide, and Albumin in Hepatorenal Syndrome

Background: Terlipressin with albumin is recommended in hepatorenal syndrome (HRS). Terlipressin is expensive and not licensed in many countries. Alternative therapy is necessary. We compared the efficacy of terlipressin and albumin with concurrent low-dose dopamine, furosemide, and albumin in HRS. Methods: In an open-label, randomized trial, forty consecutive patients each with HRS type I and HRS type II received either concurrent infusion of terlipressin 0.5 mg for every 6 hr and albumin 20 g/day for 5 days (n = 20) or a combination of dopamine 2 μg/kg/min, furosemide 0.01 mg/kg/hr, and albumin 20 g/day (triple therapy), in one of two therapeutic arms. Twenty-four-hour urine output, urinary sodium, and plasma renin activity (PRA) were assessed before and after treatment. Results: The two groups were comparable at baseline in both HRS-I and II. In HRS-I, 24 hr urine output and urine sodium at the end of 5 days increased in both treatment groups (terlipressin, urine output 278 ± 136 to 765 ± 699 ml/day, P < 0.01; urine sodium 28 ± 25.1 to 39 ± 32.1 meq/l, P = 0.05. Triple therapy: urine output 219 ± 134 to 706 ± 595 ml/day, P < 0.01; urine sodium 25 ± 18.3 to 41 ± 27.5 meq/l, P < 0.01). PRA (ng/ml/hr) decreased from 28.1 ± 9.76 to 24.2 ± 9.5 (P = 0.01) and from 29.5 ± 15.8 to 27.3 ± 17.1 (P = 0.02) in the terlipressin and triple therapy groups, respectively. In HRS-II, similar significant improvement (P < 0.01) was seen in 24 hr urine output and urine sodium; decrease in PRA (P < 0.05) was documented after treatment in both the arms. Post-treatment changes in parameters were comparable between the two arms, in both HRS-I and HRS-II cases. Conclusions: Concurrent triple therapy improved renal function in HRS and was less expensive than terlipressin (Registration: CTRI/2011/07/001860; www.ctri.nic.in).