Abstract
Background Hepatorenal Syndrome (HRS) is a severe complication of end-stage liver disease characterized by functional renal impairment. This study aimed to assess the efficacy of norepinephrine compared to midodrine/octreotide in managing patients diagnosed with hepatorenal syndrome type 1. Materials and Methods In this double-blind Randomized Clinical Trial, 50 patients with hepatorenal syndrome type 1 were randomly assigned to the norepinephrine and midodrine/octreotide groups. The norepinephrine group received an initial dose of 1 mg/h (up to a maximum of 4 mg/h) along with daily intravenous injections of 20% albumin (20-40 grams per day) throughout the study period. The control group received midodrine (maximum dose of 15 mg three times a day), octreotide (maximum dose of 200 micrograms intravenously three times a day), and 20 to 40 mg of 20% albumin daily. The primary efficacy measure was the percentage of patients achieving a complete response, defined by the restoration of serum creatinine levels to within 0.3 mg/dl of the baseline by the end of treatment. Results There was no significant difference in the rate of complete response between the norepinephrine group (7/25, 28%) and the midodrine/octreotide group (3/25, 12%) (p=0.15). The mortality rate was 10 (40%) in the norepinephrine group and 12 (48%) in the midodrine/octreotide group. Although the mortality rate was higher in the midodrine/octreotide group (12/25, 48%) compared to the norepinephrine group (10/25, 40%), this difference was not statistically significant (p=0.77). Conclusion The study findings suggest that the norepinephrine treatment regimen can be as effective as or more effective than the midodrine/octreotide regimen in treating hepatorenal syndrome in cirrhotic patients. Therefore, these two treatment regimens can be used interchangeably. Clinical Trial Registration Number IRCT20230228057568N1
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