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

July 21, 2012
December 14, 2013
August 2012
August 2014   (final data collection date for primary outcome measure)
the Response to treatment in each intervention group [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01649037 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 ]
Not Provided
Not Provided
 
To Compare the Efficacy of Nor Adrenaline and Terlipressin vs Step up Terlipressin Therapy in Hepatorenal Syndrome'
A Randomised, Open Label Study to Compare the Efficacy of Nor Adrenaline and Terlipressin vs Step up Terlipressin Therapy in Hepatorenal Syndrome'

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Hepatorenal Syndrome
  • 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.
  • Experimental: nor adrenaline and terlipressin
    Intervention: Drug: nor adrenaline and terlipressin
  • Active Comparator: step up terlipressin
    Intervention: Drug: step up terlipressin therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
80
August 2014
August 2014   (final data collection date for primary outcome measure)

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.

Both
18 Years to 65 Years
No
Contact: Dr Ankur Jindal, MD 011-46300000 ankur.jindal3@gmail.com
Contact: Dr Ankit Bhardwaj 011-46300000 bhardwaj.ankit3@gmail.com
India
 
NCT01649037
ILBS-AKI-01
No
Institute of Liver and Biliary Sciences, India
Institute of Liver and Biliary Sciences, India
Not Provided
Not Provided
Institute of Liver and Biliary Sciences, India
December 2013

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