Comparison of Terlipressin Versus Octreotide in Patients With Hepatorenal Syndrome

March 5, 2026 updated by: Muhammad Irfan Jamil, Lahore General Hospital
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab Province
      • Lahore, Punjab Province, Pakistan, 54000
        • Lahore General Hospital, Lahore

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group Terlipressin
Participants will receive terlipressin as per study protocol for the treatment of hepatorenal syndrome.
Drug: terlipressin
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
Active Comparator: Group Octreotide
Participants will receive octreotide as per study protocol for the treatment of hepatorenal syndrome.
Drug: Octreotide (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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline and 48 hours after initiation of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lahore General Hospital

Investigators

  • Principal Investigator: Muhammad Hasnain, Lahore General Hospital, Lahore

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2025

Primary Completion (Actual)

October 30, 2025

Study Completion (Actual)

October 30, 2025

Study Registration Dates

First Submitted

March 5, 2026

First Submitted That Met QC Criteria

March 5, 2026

First Posted (Actual)

March 10, 2026

Study Record Updates

Last Update Posted (Actual)

March 10, 2026

Last Update Submitted That Met QC Criteria

March 5, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LahoreGeneralH15

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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