To Compare the Efficacy of Nor Adrenaline and Terlipressin vs Step up Terlipressin Therapy in Hepatorenal Syndrome
|ClinicalTrials.gov Identifier: NCT01649037|
Recruitment Status : Withdrawn (lack of funds)
First Posted : July 25, 2012
Last Update Posted : August 31, 2016
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 or disease||Intervention/treatment||Phase|
|Hepatorenal Syndrome||Drug: nor adrenaline and terlipressin Drug: step up terlipressin therapy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomised, Open Label Study to Compare the Efficacy of Nor Adrenaline and Terlipressin vs Step up Terlipressin Therapy in Hepatorenal Syndrome|
|Study Start Date :||August 2012|
|Estimated Primary Completion Date :||June 2015|
|Estimated Study Completion Date :||June 2015|
|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.
- 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01649037
|Institute of Liver and Biliary Sciences|
|New Delhi, Delhi, India, 110070|