Hepatorenal syndrome is a serious complication of advanced liver disease in which kidney function rapidly worsens and can lead to life-threatening illness. Effective treatment is essential because delayed improvement in kidney function is associated with poor short-term outcomes. This randomized controlled trial will compare two commonly used medicines, terlipressin and octreotide, for the treatment of hepatorenal syndrome in adult patients admitted to Medical Unit III, Lahore General Hospital, Lahore. A total of 60 eligible patients (30 to 70 years of age) will be enrolled using consecutive sampling and randomly allocated in a 1:1 ratio to receive either terlipressin or octreotide according to the study protocol. The main study outcome will be treatment response within 48 hours, assessed by change in serum creatinine. Response will be categorized as complete (serum creatinine less than 1.5 mg/dL at 48 hours), partial (more than 50% reduction from baseline but serum creatinine remains above 1.5 mg/dL), or no response (less than 50% reduction from baseline). It is hypothesized that there is a difference in the clinical response between terlipressin and octreotide in patients with hepatorenal syndrome.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
60
Dose and route: 2 mg intravenous bolus, followed by 1 mg intravenously every 6 hours Treatment duration for primary assessment: 48 hours
Dose and route: 100 micrograms intravenous bolus, prepared as 1 microgram per 1 mL in 0.45% dextrose saline Treatment duration for primary assessment: 48 hours
Lahore General Hospital, Lahore
Lahore, Punjab Province, Pakistan
Treatment response based on serum creatinine at 48 hours
Treatment response will be assessed using the change in serum creatinine from baseline to 48 hours after initiation of study drug. Response will be categorized as: Complete response: serum creatinine \< 1.5 mg/dL at 48 hours Partial response: \> 50% decrease in serum creatinine from baseline, but serum creatinine remains \> 1.5 mg/dL at 48 hours No response: \< 50% decrease in serum creatinine from baseline at 48 hours
Time frame: Baseline and 48 hours after initiation of treatment
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