To Compare the Efficacy of Nor Adrenaline and Terlipressin vs Step up Terlipressin Therapy in Hepatorenal Syndrome

Institute of Liver and Biliary Sciences, India

Overview

All consecutive patients with liver cirrhosis having Acute Kidney Injury at admission or during hospitalization will be included in the study. The diagnosis of liver cirrhosis will be based on the clinical grounds including Laboratory tests, endoscopic evidence, imaging (Ultrasonography/computed tomography) findings, and liver histology, when available.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

Hepatorenal Syndrome

Interventions

nor adrenaline and terlipressinDRUG

IV bolus terlipressin at the dose of 0.5 to 1 mg every 6 hours with the maximum daily cumulative dose of 4 mg/day. Continuous IV infusion of NA starting at 0.5 mg/h with doubling of dose after every 4 hours in case of no response.\[ No response defined as MAP \< 10, or 4 hr Urine output \< 200 ml\] with maximum dose upto 3 mg/h.

step up terlipressin therapyDRUG

IV bolus terlipressin starting at 1.5 mg every 6 hours with increase in dose by 0.5 mg/6 hours in case of no response \[\< 25% decrease in s.creatinine\] after every 48 hours. Maximum daily cumulative dose of 12 mg/day.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: \- Patients with Liver cirrhosis and acute kidney injury. Patients consented for the study protocol by signing the informed consent. Exclusion Criteria: \- Age less than 18 years Cirrhotics with kidney injury managed as outpatients. Patients undergoing renal replacement therapy (hemodialysis/renal transplantation). Post liver transplantation patients. Hepatocellular carcinoma. History of coronary artery disease, ischaemic cardiomyopathy, ventricular arrhythmia, or peripheral vascular disease. Patients with obstructive uropathy. Patient who withdrew or non complaint to the study protocol.

Locations (1)

Institute of Liver and Biliary Sciences

New Delhi, National Capital Territory of Delhi, India

Outcomes

Primary Outcomes

the Response to treatment in each intervention group

Time frame: 2 years

Secondary Outcomes

Survival

Time frame: 15 days

Side effects of the drug

Time frame: 3 months

Complications and the predictors of the treatment response

Time frame: 2 years

Data from ClinicalTrials.gov

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