Comparison of Terlipressin Versus Octreotide in Patients With Hepatorenal Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Treatment response based on serum creatinine at 48 hours
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 30 Years 至 70 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 30 to 70 years
- •Either gender
- •Diagnosed with hepatorenal syndrome
排除标准
- •Hepatocellular carcinoma
- •Septic shock
- •Cardiac failure
- •Respiratory failure
- •Coronary artery disease
研究组 & 干预措施
Group Terlipressin
Participants will receive terlipressin as per study protocol for the treatment of hepatorenal syndrome.
干预措施: terlipressin (Drug)
Group Octreotide
Participants will receive octreotide as per study protocol for the treatment of hepatorenal syndrome.
干预措施: Octreotide (drug) (Drug)
结局指标
主要结局
Treatment response based on serum creatinine at 48 hours
时间窗: 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
次要结局
未报告次要终点
研究者
Muhammad Irfan Jamil
Principal Investigator
Lahore General Hospital
