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.
|Hepatorenal Syndrome||Drug: nor adrenaline and terlipressin Drug: step up terlipressin therapy|
|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|
- the Response to treatment in each intervention group [ Time Frame: 2 years ]
- 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 ]
|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)|
|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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01649037
|Institute of Liver and Biliary Sciences|
|New Delhi, Delhi, India, 110070|