Back to resultsTo Compare the Efficacy of Nor Adrenaline and Terlipressin vs Step up Terlipressin Therapy in Hepatorenal Syndrome
Primary Purpose
Hepatorenal Syndrome
Status
Withdrawn
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
nor adrenaline and terlipressin
step up terlipressin therapy
Sponsored by
About this trial
This is an interventional treatment trial for Hepatorenal Syndrome
Eligibility 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.
Sites / Locations
- Institute of Liver and Biliary Sciences
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
nor adrenaline and terlipressin
step up terlipressin
Arm Description
Outcomes
Primary Outcome Measures
the Response to treatment in each intervention group
Secondary Outcome Measures
Survival
Side effects of the drug
Complications and the predictors of the treatment response
Full Information
NCT ID
NCT01649037
First Posted
July 21, 2012
Last Updated
August 30, 2016
Sponsor
Institute of Liver and Biliary Sciences, India
1. Study Identification
Unique Protocol Identification Number
NCT01649037
Brief Title
To Compare the Efficacy of Nor Adrenaline and Terlipressin vs Step up Terlipressin Therapy in Hepatorenal Syndrome
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 Type
Interventional
2. Study Status
Record Verification Date
December 2013
Overall Recruitment Status
Withdrawn
Why Stopped
lack of funds
Study Start Date
August 2012 (undefined)
Primary Completion Date
June 2015 (Anticipated)
Study Completion Date
June 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institute of Liver and Biliary Sciences, India
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatorenal Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
nor adrenaline and terlipressin
Arm Type
Experimental
Arm Title
step up terlipressin
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
nor adrenaline and terlipressin
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
step up terlipressin therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
the Response to treatment in each intervention group
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Survival
Time Frame
15 days
Title
Side effects of the drug
Time Frame
3 months
Title
Complications and the predictors of the treatment response
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Institute of Liver and Biliary Sciences
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110070
Country
India
12. IPD Sharing Statement
Learn more about this trial
To Compare the Efficacy of Nor Adrenaline and Terlipressin vs Step up Terlipressin Therapy in Hepatorenal Syndrome
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