Role of Terlipressin and Albumin Combination versus Albumin Alone in Hepatorenal Syndrome

Abstract

Purpose: Hepatorenal Syndrome is potentially fatal complication of decompensated cirrhosis. Major pathogenetic factor is systemic arterial vasodilatation with arterial underfilling and renal vasoconstriction. Vasoconstrictor therapy (terlipressin) is used to increase systemic vasoconstriction. Albumin improves intravascular filling and reduces extent of systemic arterial vasodilatation, thus improving result of Terlipressin. We performed this study to see the impact of both modalities on disease outcome. Methods: Fifty patients hospitalized with HRS, were randomly assigned either terlipressin (1mg/4 hourly, IV), and albumin (1 g/kg followed by 20-40 g/day) (n=25) or albumin alone (n=25) for a period of 7 to 10 days. Inclusion criteria: (1) cirrhosis diagnosed by liver biopsy or clinical, biochemical, ultrasound, or endoscopic findings; (2) HRS either type 1, or type 2 with serum crt > 2mg/dL; (3) age 18 to 75 years; (4) absence of bacterial infection (5) absence of cardiovascular diseases (6) absence organic nephropathy; and (7) absence of HCC. Primary outcomes were improvement of renal function and survival at 3 months. Final analysis was conducted on an intention-to-treat basis. Comparisons between groups were performed with the use of the χ2 test or Fisher exact test and Mann-Whitney/Wilcoxon tests for continuous data. Data was analyzed with SPSS 14.0 software. Results are presented as mean ± SD. P values are 2-tailed, and values <.05 were considered statistically significant. Results: Improvement of renal function was more frequent in patients given Terli+Riba than in patients given albumin alone: 10 out of 25 patients (40%), compared with 2 out of 25 patients (8.0%), (P<.05). Patients of Terli+Alb group, 7 had type 1 HRS, and 3 had type 2 HRS. 2 patients who responded in Alb group had type 1 HRS. Duration of treatment was 10 days ± 2 days. In Terli + Alb group, serum crt decreased from 3.9 ± 0.6 to 1.2 ±0.4 mg/dL (P <.05) and MAP increased from 85 ±12 to 74 ±12 mm Hg (P =.02). There were no significant difference in 2 groups with respect to the number of patients who were alive at 3 months, 6 in the Terli+Alb group (24%) and 5 in the albumin group (20%) (P=.6). A univariate analysis of survival showed that baseline bilirubin, PT, serum crt, CPT score, MELD score and response to therapy were associated with prognosis. In multivariate analysis, predictive factors of 3-month survival were baseline MELD score and therapy response. Conclusion: Results of this study indicate that terlipressin and albumin are effective in improving renal function in patients with cirrhosis and HRS compared with albumin administration alone. However, there is no significant effect of Terli+Riba therapy on survival.