Terlipressin Given As I.V. Boluses Versus Terlipressin Given As Continuous Intravenous Infusion In Patients With Cirrhosis And Type 1 Hepatorenal Syndrome

Study Overview
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Brief Summary
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It is well known that terlipressin and albumin improve renal function in patients with cirrhosis and type 1 HRS. In previous studies terlipressin has been used either as intravenous boluses moving from an initial dose of 0.5-1 mg/4 hr or as continuous intravenous infusion at the initial dose of 2 mg/24 h. Up to now the two schedules of i.v. administration of terlipressin have never been compared. Nevertheless, it has been hypothesized that continuous intravenous infusion assures a more steady profile of effect on portal pressure in patients with cirrhosis. Thus, the aim of the study will be to compare terlipressin given as i.v. bolus vs terlipressin given as continuous intravenous infusion in the treatment of type 1 HRS in patients with cirrhosis.

Official Title
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Terlipressin Given As I.V. Boluses Vs Terlipressin Given As Continuous Intravenous Infusion In Patients With Cirrhosis And Type 1 Hepatorenal Syndrome (Hrs): Preliminary Results Of A Randomized Controlled Clinical Study.

Conditions
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Cirrhosis, Type 1 Hepatorenal Syndrome

Intervention / Treatment
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* Drug: terlipressin given by intravenous boluses and albumin
* Drug: terlipressin given by continuous intravenous infusion and albumin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with cirrhosis and type 1 HRS Exclusion Criteria: HCC beyond the Milan Criteria,septic shock (systolic arterial pressure < 90 mmHg, Significant heart or respiratory failure, Peripheral arteriophaty clinically significant, Previous heart stroke or significant alteration of the ECG

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>35 patients with cirrhosis and type 1 HRS | Drug: terlipressin given by intravenous boluses and albumin<br>* Patients who will be randomly assigned to arm 1 will received terlipressin given by intravenous boluses at the initial dose of terlipressin was 0.5 mg/4 hr. In case of non response, the dose of terlipressin was progressively increased up to a maximum of 2 mg/4 hr. Human albumin will be given intravenously at the dose of 1 g/kg of body weight on the first day followed by 20-40 g/day.<br>|
| Experimental: 2<br>35 patients with cirrhosis and type 1 HRS | Drug: terlipressin given by continuous intravenous infusion and albumin<br>* Patients who will be randomly assigned to arm 1 will received terlipressin given as intravenous boluses at the initial dose of 0.5 mg/4 hr. In case of non response, the dose of terlipressin will be progressively increased up to a maximum of 2 mg/4 hr. Human albumin will be given at the dose of 1 g/kg of body weight at the first day followed by 20-40 g/day.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary end-point of the study is the complete reform of the renal function (creatinine < 1.5 mg/dl). |  | The treatment will be continued for a maximum of 15 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cirrhosis, type 1 hepatorenal syndrome, terlipressin, albumin, effective circulating volume, Patients, with