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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group Terlipressin | Experimental | Participants will receive terlipressin as per study protocol for the treatment of hepatorenal syndrome. |
|
| Group Octreotide | Active Comparator | Participants will receive octreotide as per study protocol for the treatment of hepatorenal syndrome. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| terlipressin | Drug | Dose and route: 2 mg intravenous bolus, followed by 1 mg intravenously every 6 hours Treatment duration for primary assessment: 48 hours |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Muhammad Hasnain | Lahore General Hospital, Lahore | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lahore General Hospital, Lahore | Lahore | Punjab Province | 54000 | Pakistan |
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| ID | Term |
|---|---|
| D006530 | Hepatorenal Syndrome |
| D058186 | Acute Kidney Injury |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| ID | Term |
|---|---|
| D000077585 | Terlipressin |
| D015282 | Octreotide |
| D004364 | Pharmaceutical Preparations |
| ID | Term |
|---|---|
| D008236 | Lypressin |
| D014667 | Vasopressins |
| D010909 | Pituitary Hormones, Posterior |
| D010907 | Pituitary Hormones |
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|
| 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 |
|
|
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D051437 | Renal Insufficiency |
| D036361 |
| Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |