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OpenTrials
Completed

NCT Number: NCT07460908

Comparison of Terlipressin Versus Octreotide in Patients With Hepatorenal Syndrome

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.

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Key information

Age range

30 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lahore General Hospital, Lahore

Lahore, Punjab Province, 54000, Pakistan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Terlipressin

Drug

Dose and route: 2 mg intravenous bolus, followed by 1 mg intravenously every 6 hours Treatment duration for primary assessment: 48 hours

Other names: Terlipressin acetate

Octreotide (drug)

Drug

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

Other names: Octreotide acetate

Primary outcomes

  1. Treatment response based on serum creatinine at 48 hours

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Lahore General Hospital

Other Gov

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 10, 2026
Registry last updated
Mar 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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