Study Stopped
lack of funds
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
1 other identifier
interventional
N/A
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Aug 2012
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 21, 2012
CompletedFirst Posted
Study publicly available on registry
July 25, 2012
CompletedStudy Start
First participant enrolled
August 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedAugust 31, 2016
December 1, 2013
2.8 years
July 21, 2012
August 30, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
the Response to treatment in each intervention group
2 years
Secondary Outcomes (3)
Survival
15 days
Side effects of the drug
3 months
Complications and the predictors of the treatment response
2 years
Study Arms (2)
nor adrenaline and terlipressin
EXPERIMENTALstep up terlipressin
ACTIVE COMPARATORInterventions
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.
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 Criteria
You may qualify if:
- \- Patients with Liver cirrhosis and acute kidney injury. Patients consented for the study protocol by signing the informed consent.
You may not qualify if:
- \- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Institute of Liver and Biliary Sciences
New Delhi, National Capital Territory of Delhi, 110070, India
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 21, 2012
First Posted
July 25, 2012
Study Start
August 1, 2012
Primary Completion
June 1, 2015
Study Completion
June 1, 2015
Last Updated
August 31, 2016
Record last verified: 2013-12