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

NCT01649037 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2016-08-31

No results posted yet for this study

Summary

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.

Conditions

  • Hepatorenal Syndrome

Interventions

DRUG

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.

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.

Sponsors & Collaborators

  • Institute of Liver and Biliary Sciences, India

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-08-31
Primary Completion
2015-06-30
Completion
2015-06-30

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01649037 on ClinicalTrials.gov