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

This study is currently recruiting participants.

Verified April 2013 by Institute of Liver and Biliary Sciences, India

Sponsor:

Information provided by (Responsible Party):

Institute of Liver and Biliary Sciences, India

ClinicalTrials.gov Identifier:

NCT01649037

First received: July 21, 2012

Last updated: May 1, 2013

Last verified: April 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

July 21, 2012

Last Updated Date

May 1, 2013

Start Date ^ICMJE

August 2012

Estimated Primary Completion Date

August 2014 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

the Response to treatment in each intervention group [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01649037 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Survival [ Time Frame: 15 days ] [ Designated as safety issue: Yes ]
Side effects of the drug [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
Complications and the predictors of the treatment response [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Survival [ Time Frame: 15 days ] [ Designated as safety issue: Yes ]
Side effects of the drug [ Time Frame: 3 months ]
Complications and the predictors of the treatment response [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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 Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

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

Condition ^ICMJE

Hepatorenal Syndrome

Intervention ^ICMJE

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.

Study Arm (s)

Experimental: nor adrenaline and terlipressin
Intervention: Drug: nor adrenaline and terlipressin
Active Comparator: step up terlipressin
Intervention: Drug: step up terlipressin therapy

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

August 2014

Estimated Primary Completion Date

August 2014 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Dr Ankur Jindal, MD	011-46300000	ankur.jindal3@gmail.com
Contact: Dr Ankit Bhardwaj	011-46300000	bhardwaj.ankit3@gmail.com

Location Countries ^ICMJE

India

Administrative Information

NCT Number ^ICMJE

NCT01649037

Other Study ID Numbers ^ICMJE

ILBS-AKI-01

Has Data Monitoring Committee

Responsible Party

Institute of Liver and Biliary Sciences, India

Study Sponsor ^ICMJE

Institute of Liver and Biliary Sciences, India

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Not Provided

Information Provided By

Institute of Liver and Biliary Sciences, India

Verification Date

April 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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