Comparison of noradrenaline with the combination of octreotide and midodrine in the treatment of hepatorenal syndrome type 1

Authors
Category Primary study
Registry of TrialsIranian Registry of Clinical Trials
Year 2023
INTERVENTION: Intervention 1: Intervention group: Patients receiving Noradrenaline and Albumin treatment/ In this group, patients with Hepatorenal Syndrome were treated with Noradrenaline at an initial dose of 1 mg/h with continuous injection and then gradually increased to a maximum dose of 4 mg/h in order to achieve a minimum urine output of at least 400 ml per 12 hours + Receiving Albumin on the first day of 1 gram per kilogram of body weight and then 20 to 40 grams per day intravenously for up to 14 days/ basic and clinical and laboratory information in both groups at the beginning and then on days 1, 3, 7, and 14 and the maximum time Readmission will be checked. Intervention 2: Control group: standard treatment of patients with Midodrine, Octreotide and albumin (receive Midodrine orally with an initial dose of 7.5 mg three times a day, with a dose increase up to a maximum of 12.5 mg three times a day, together with Octreotide subcutaneously: initial dose 100 µg three times a day and up to 200 µg three times a day +Receiving Albumin on the first day of 1 gram per kilogram of body weight and then 20 to 40 grams per day intravenously for up to 14 days / basic and clinical and laboratory information in both groups at the beginning and then on days 1, 3, 7, and 14 and the maximum time Readmission will be checked. CONDITION: Hepatorenal Syndrome. ; Hepatorenal syndrome K76.7 PRIMARY OUTCOME: Increase in 4‐hour urine output above 200 ml. Timepoint: Before the intervention and days 1, 3, 7 and 14. Method of measurement: Blood and urine samples. Reduction of serum creatinine level below 1.5 mg. Timepoint: Before the intervention and days 1, 3, 7 and 14. Method of measurement: Blood and urine samples. Statistically significant improvement in serum creatinine and sodium levels. Timepoint: Before the intervention and days 1, 3, 7 and 14. Method of measurement: Blood and urine samples. SECONDARY OUTCOME: Treatment of hepatorenal syndrome and mortality rate. Timepoint: Beginning and end of day 14. Method of measurement: Blood/urine samples and bedside examination. INCLUSION CRITERIA: Diagnosis based on modified HRS diagnostic criteria in 2007: Cirrhosis with ascites and increased serum creatinine level (>1.5 mg/dL) with non‐recovery up to 48 hours after diuretic discontinuation and volume increase with albumin Absence of shock Not receiving nephrotoxic drugs Absence of kidney parenchymal disease or obstructive uropathy in laboratory and ultrasound assessment Doubling of creatinine level to more than 2.5 mg/dL in 2 weeks or less
Epistemonikos ID: 8037821e480b0ed63d10e87b539756c111d078c9
First added on: Feb 20, 2024