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

Information source: Institute of Liver and Biliary Sciences, India
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hepatorenal Syndrome

Intervention: nor adrenaline and terlipressin (Drug); step up terlipressin therapy (Drug)

Phase: N/A

Status: Withdrawn

Sponsored by: Institute of Liver and Biliary Sciences, India

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.

Clinical Details

Official title: A Randomised, Open Label Study to Compare the Efficacy of Nor Adrenaline and Terlipressin vs Step up Terlipressin Therapy in Hepatorenal Syndrome'

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: the Response to treatment in each intervention group

Secondary outcome:

Survival

Side effects of the drug

Complications and the predictors of the treatment response

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

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 and Contacts

Institute of Liver and Biliary Sciences, New Delhi, Delhi 110070, India
Additional Information

Starting date: August 2012
Last updated: August 11, 2015

Page last updated: August 23, 2015

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