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临床试验/NCT07460908
NCT07460908已完成不适用

Comparison of Terlipressin Versus Octreotide in Patients With Hepatorenal Syndrome

Lahore General Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年5月1日最近更新:
适应症
干预措施

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

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

Experimental

Participants will receive terlipressin as per study protocol for the treatment of hepatorenal syndrome.

干预措施: terlipressin (Drug)

Group Octreotide

Active Comparator

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

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Muhammad Irfan Jamil

Principal Investigator

Lahore General Hospital

研究点 (1)

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