Comparison of Terlipressin Versus Octreotide in Patients With Hepatorenal Syndrome

NCT07460908 | Completed

• 1 other identifier: LahoreGeneralH15
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatorenal Syndrome

Keywords

Advanced liver disease; Acute kidney injury; Serum creatinine; Vasoconstrictor therapy; Terlipressin; Octreotide

Outcome Measures

Primary Outcomes (1)

• Treatment response based on serum creatinine at 48 hours

  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

Study Arms (2)

Group Terlipressin

EXPERIMENTAL

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

Drug: terlipressin

Group Octreotide

ACTIVE COMPARATOR

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

Drug: Octreotide (drug)

Interventions

terlipressin DRUG

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

Also known as: Terlipressin acetate

Group Terlipressin

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

Also known as: Octreotide acetate

Group Octreotide

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 30 to 70 years
• Either gender
• Diagnosed with hepatorenal syndrome

You may not qualify if:

• Hepatocellular carcinoma
• Septic shock
• Cardiac failure
• Respiratory failure
• Stroke
• Coronary artery disease

Sponsors & Collaborators

• Lahore General Hospital: lead

Study Sites (1)

Lahore General Hospital, Lahore

Lahore, Punjab Province, 54000, Pakistan

Location

MeSH Terms

Conditions

Hepatorenal Syndrome; Acute Kidney Injury

Interventions

Terlipressin; Octreotide; Pharmaceutical Preparations

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Renal Insufficiency

Intervention Hierarchy (Ancestors)

Lypressin; Vasopressins; Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds

Study Officials

• Muhammad Hasnain

  Lahore General Hospital, Lahore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 5, 2026
• First Posted: March 10, 2026
• Study Start: May 1, 2025
• Primary Completion: October 30, 2025
• Study Completion: October 30, 2025
• Last Updated: March 10, 2026

Record last verified: 2026-03

Locations

PA (1)