Hepatorenal Syndrome
Conditions
Keywords
Advanced liver disease, Acute kidney injury, Serum creatinine, Vasoconstrictor therapy, Terlipressin, Octreotide
Brief summary
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.
Interventions
DRUGterlipressin
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
Sponsors
Lahore General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
30 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Age 30 to 70 years * Either gender * Diagnosed with hepatorenal syndrome
Exclusion criteria
* Hepatocellular carcinoma * Septic shock * Cardiac failure * Respiratory failure * Stroke * Coronary artery disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment response based on serum creatinine at 48 hours | Baseline and 48 hours after initiation of treatment | 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 |
Countries
Pakistan
Contacts
PRINCIPAL_INVESTIGATORMuhammad Hasnain
Lahore General Hospital, Lahore
Outcome results
None listed