Noradrenalin Versus the Combination of Midodrine and Octreotide in Patients with Hepatorenal Syndrome: Randomized Clinical Trial

Abstract

Background: Hepatorenal syndrome (HRS) is known as development of acute renal failure in a patient who usually has advanced liver disease. The aim of the present study was to determine the safety and the efficacy of noradrenalin in comparison with midodrine‑octreotide in patients with HRS.

Methods: This study was registered to the Iranian Registry of Clinical trials (IRCT). This study was a single‑center, randomized, clinical trial that performed in Alzahra hospital, Isfahan, Iran. Since March 2011 to January 2012, twenty‑three patients were enrolled in the study. Eligible patients were allocated in 2 groups. In the first group, patients received infusion of NA with the dose of 0.1–0.7 μg/kg/min, and in the other groups, patients received octreotide 100‑200 μg subcutaneously 3 times daily and midodrine 5‑15 mg orally 3 times daily. In both study groups, patient received albumin infusion in addition to noradrenalin or midodrine‑octreotide.

Results: Complete response of HRS was observed in 8 of the 11 patients (73%) treated with noradrenalin and in 9 of the 12 patients (75%) treated with midodrine‑octreotide (P > 0.05). HRS recurred after treatment withdrawal in 2 of 11 in NA and 3 of 12 in MO group. That shows no significant difference between 2 groups (P > 0.05).

Conclusion: We deduce that NA has the same efficacy and safety with MO and can induce a complete response in high percentage of the patients. Moreover, we observed no significant differences in the recurrence rate and outcomes after 3 months among the patients in both study groups; this result could support the use of NA in HRS management. The IRCT ID is: IRCT201107217085N1.

Key words: Clinical trial, hepatorenal syndrome, midodrine, noradrenalin, octreotide