TYPE 2 HEPATORENAL SYNDROME

Post Graduate Institute of Medical Education and Research, Chandigarh46 enrolled

Overview

Various vasoconstrictors have shown promising results in the management of type 1 hepatorenal syndrome (HRS). However, there are very few studies on vasopressors in the management of type 2 HRS. Terlipressin has been used commonly; however it is costly and not available in some countries. In the present study, the investigators evaluated safety and efficacy of terlipressin and noradrenaline in the treatment of type 2 HRS

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Safety and Efficacy of Terlipressin and Noradrenaline and Predictive Factors of Response in Type 2 HRS

Interventions

NoradrenalineDRUG

Patients in group B received a continuous infusion of noradrenaline at an initial dose of 0.5 mg/hour, designed to achieve an increase in mean arterial pressure (MAP) of at least 10mmHg or an increase in 4-h urine output to more than 200 mL. When one of these goals was not achieved, the noradrenaline dose increased every 4 hour in steps of 0.5 mg/hour, up to the maximum dose of 3 mg/hour

TerlipressinDRUG

Patients in group A received terlipressin as an intravenous bolus of 0.5 mg every 6 h. If a significant reduction in serum creatinine level (≥1 mg/dL) was not observed during 3-day period, the dose of terlipressin was increased in a stepwise fashion every 3 days to a maximum of 2 mg every 6 hour

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Cirrhosis with ascites with serum creatinine more than 1.5 mg/dl and less than 2.5 mg/dl 2. Absence of shock, fluid losses and treatment with nephrotoxic drug 3. No improvement in renal function following diuretic withdrawal and plasma volume expansion 4. No ultrasound evidence of renal parenchymal disease or obstructive uropathy 5.Absence of proteinuria more than 500 mg/24 hour Exclusion Criteria: 1. Patients with history of coronary artery disease 2. Cardiomyopathy 3. Ventricular arrhythmia 4. Obstructive arterial disease of limbs -

Locations (1)

Postgraduate Institute of Medical Education and Research Chandigarh

Chandigarh, Chandigarh, India

Outcomes

Primary Outcomes

The primary end point of the study was serum creatinine less than 1.5 mg

Time frame: 15 days

Secondary Outcomes

Secondary end points include death of patients

Time frame: 15 days

Data from ClinicalTrials.gov

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