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

This study has been withdrawn prior to enrollment.
(lack of funds)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01649037
First Posted: July 25, 2012
Last Update Posted: August 31, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Institute of Liver and Biliary Sciences, India
  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
Intervention Model: Parallel Assignment
Masking: None (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 ]

Secondary Outcome Measures:
  • Survival [ Time Frame: 15 days ]
  • Side effects of the drug [ Time Frame: 3 months ]
  • Complications and the predictors of the treatment response [ Time Frame: 2 years ]

Enrollment: 0
Study Start Date: August 2012
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01649037


Locations
India
Institute of Liver and Biliary Sciences
New Delhi, Delhi, India, 110070
Sponsors and Collaborators
Institute of Liver and Biliary Sciences, India
  More Information

Responsible Party: Institute of Liver and Biliary Sciences, India
ClinicalTrials.gov Identifier: NCT01649037     History of Changes
Other Study ID Numbers: ILBS-AKI-01
First Submitted: July 21, 2012
First Posted: July 25, 2012
Last Update Posted: August 31, 2016
Last Verified: December 2013

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