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

NCT ID: NCT01649037

Last Updated: 2016-08-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2015-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Hepatorenal Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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nor adrenaline and terlipressin

Group Type EXPERIMENTAL

nor adrenaline and terlipressin

Intervention Type DRUG

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

Group Type ACTIVE_COMPARATOR

step up terlipressin therapy

Intervention Type DRUG

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.

Interventions

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nor adrenaline and terlipressin

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.

Intervention Type DRUG

step up terlipressin therapy

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.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institute of Liver and Biliary Sciences, India

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Institute of Liver and Biliary Sciences

New Delhi, National Capital Territory of Delhi, India

Site Status

Countries

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India

Other Identifiers

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ILBS-AKI-01

Identifier Type: -

Identifier Source: org_study_id

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