Treatment of Hepatorenal Syndrome With Terlipressin Plus Albumin vs Albumin

Hospital Clinic of Barcelona100 enrolled

Overview

Hepatorenal syndrome is a common complication of cirrhotic patients. The prognosis of patients with HRS is very poor. It have been demonstrated that vasoconstrictors agents (Terlipressin) plus albumin are effective in the reversal of the treatment. However, previous studies are pilot studies and they are not able to give information about an improvement in survival. This comparative randomized study was delineated to test the efficacy of terlipressin on survival.

Phase 3

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

100

Conditions

Cirrhosis Hepatorenal Syndrome

Interventions

terlipressinDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Patients with HRS type 1 or 2 with serum creatinine \>2 mg/dL 2. Age between 18 and 75 years 3. Written informed consent. 4. Absence of exclusion criteria Exclusion Criteria: 1. Hepatocarcinoma (3 nodules greater than 3 cm or 1 nodule \> than 5 cm) 2. Active infection with systemic inflammatory response syndrome 3. Respiratory or cardiac dysfunction. 4. Arteriopathy. 5. Ischemic cardiopathy. 6. Arterial hypertension ( \>140/90 mmHg during hospitalization )

Locations (1)

Hospital Clinic

Barcelona, Barcelona, Spain

Outcomes

Primary Outcomes

Survival

Data from ClinicalTrials.gov

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