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

Not Applicable

Withdrawn

• Conditions: Hepatorenal Syndrome
• Interventions: Drug: nor adrenaline and terlipressin; Drug: step up terlipressin therapy

• Registration Number: NCT01649037
• Lead Sponsor: Institute of Liver and Biliary Sciences, India

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-07-21
• Study First Submitted QC: 2012-07-21
• Study First Posted: 2012-07-25
• Study Start: 2012-08
• Status Verified: 2013-12
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Last Update Submitted: 2016-08-30
• Last Update Posted: 2016-08-31

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
nor adrenaline and terlipressin	nor adrenaline and terlipressin	-
step up terlipressin	step up terlipressin therapy	-

Primary Outcome Measures

Name	Time	Method
the Response to treatment in each intervention group	2 years

Secondary Outcome Measures

Name	Time	Method
Complications and the predictors of the treatment response	2 years
Side effects of the drug	3 months
Survival	15 days

Trial Locations

Locations (1)

Institute of Liver and Biliary Sciences; 🇮🇳 New Delhi, Delhi, India