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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 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: December 14, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention
Hepatorenal Syndrome
Drug: nor adrenaline and terlipressin
Drug: step up terlipressin therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomised, Open Label Study to Compare the Efficacy of Nor Adrenaline and Terlipressin vs Step up Terlipressin Therapy in Hepatorenal Syndrome'

Resource links provided by NLM:


Further study details as provided by Institute of Liver and Biliary Sciences, India:

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

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 80
Study Start Date: August 2012
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: nor adrenaline and terlipressin 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.

Active Comparator: step up terlipressin 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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01649037

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

Locations
India
Institute of Liver and Biliary Sciences Recruiting
New Delhi, Delhi, India, 110070
Contact: Dr Ankur Jindal, MD    011-46300000      
Contact: Dr Ankit Bhardwaj    011-46300000 ext 1032    bhardwaj.ankit3@gmail.com   
Sponsors and Collaborators
Institute of Liver and Biliary Sciences, India
  More Information

No publications provided

Responsible Party: Institute of Liver and Biliary Sciences, India
ClinicalTrials.gov Identifier: NCT01649037     History of Changes
Other Study ID Numbers: ILBS-AKI-01
Study First Received: July 21, 2012
Last Updated: December 14, 2013
Health Authority: India: Institutional Review Board

Additional relevant MeSH terms:
Hepatorenal Syndrome
Liver Diseases
Digestive System Diseases
Kidney Diseases
Urologic Diseases
Epinephrine
Norepinephrine
Epinephryl borate
Terlipressin
Lypressin
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Mydriatics
Adrenergic alpha-Agonists
Sympathomimetics
Vasoconstrictor Agents
Cardiovascular Agents
Antihypertensive Agents
Antidiuretic Agents

ClinicalTrials.gov processed this record on July 22, 2014