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To Compare the Response Rate of Noradrenaline vs. Terlipressin in Hepatorenal Syndrome in Patients With Acute on Chronic Liver Failure

Primary Purpose

Acute on Chronic Liver Failure

Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Nor adrenaline + albumin
Terlipressin + albumin
Sponsored by
Institute of Liver and Biliary Sciences, India
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute on Chronic Liver Failure

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Patients with acute on chronic liver failure presenting with hepatorenal syndrome
  2. Patients consented for the study protocol by signing the informed consent.

Exclusion Criteria:

  1. Age less than 18 years
  2. Decompensated cirrhotics
  3. Evidence of chronic kidney disease
  4. Patients undergoing renal replacement therapy (hemo-dialysis/renal transplantation).
  5. Post liver transplantation patients.
  6. History of coronary artery disease, ischaemic cardiomyopathy, ventricular arrhythmia, or peripheral vascular disease.
  7. Patients with obstructive uropathy.
  8. 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 + Albumin

Terlipressin + Albumin

Arm Description

Intravenous continous infusion of terlipressin at the dose of 2 mg every 24 hours with the maximum daily cumulative dose of 12 mg/day. In case of no response the dose of the terlipressin will be progressively increased to the maximum infusion dose of 12 mg/24 hour. Patients will be given 1g/Kg of albumin per day, which will be discontinued if CVP is more than 18 cm H2O.

Continuous IV infusion of NA starting at 0.5 mg/h with doubling of dose after every 4 hours designed to achieve an increase in MAP of at least 10 mmHg or an increase in 4-h urine output of more than 200 ml. When one of these goals was not achieved, the noradrenaline dose was increased every 4 h in steps of 0.5 mg/h, up to the maximum dose of 3 mg/h. Patients will be given 1g/Kg of albumin per day, which will be discontinued if CVP is more than 18 cm H2O.

Outcomes

Primary Outcome Measures

Response to treatment in each intervention group
Complete response: Regression of acute kidney injury stage with reduction of S. Cr within 0.3 mg/dl of baseline (ii) Partial response: Regression of acute kidney injury stage with reduction of S. Cr to ≥0.3 mg/dl above baseline (iii) No response: No regression of acute kidney injury.

Secondary Outcome Measures

Survival
Drug related Side effects/complications

Full Information

First Posted
October 5, 2015
Last Updated
November 14, 2017
Sponsor
Institute of Liver and Biliary Sciences, India
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1. Study Identification

Unique Protocol Identification Number
NCT02573727
Brief Title
To Compare the Response Rate of Noradrenaline vs. Terlipressin in Hepatorenal Syndrome in Patients With Acute on Chronic Liver Failure
Official Title
''To Compare the Response Rate of Noradrenaline vs. Terlipressin in Hepatorenal Syndrome in Patients With Acute on Chronic Liver Failure'
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
October 2015 (undefined)
Primary Completion Date
January 2017 (Actual)
Study Completion Date
January 2017 (Actual)

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
Continous infusion of nor adrenaline + albumin Continous infusion of terlipressin + albumin Response will assessed at every 48 hour (i) Complete response: Regression of acute kidney injury stage with reduction of S. Cr within 0.3 mg/dl of baseline (ii) Partial response: Regression of acute kidney injury stage with reduction of S. Cr to ≥0.3 mg/dl above baseline (iii) No response: No regression of acute kidney injury Treatment will be extended until reversal of HRS (decrease in creatinine below 1.5 mg/dL) or for a maximum of 7 days after rescue treatment will be followed. If intolerant to terlipressin, excluded from study and rescue treatment will be given in form of noradrenaline or octreotide and midodrine.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute on Chronic Liver Failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nor Adrenaline + Albumin
Arm Type
Experimental
Arm Description
Intravenous continous infusion of terlipressin at the dose of 2 mg every 24 hours with the maximum daily cumulative dose of 12 mg/day. In case of no response the dose of the terlipressin will be progressively increased to the maximum infusion dose of 12 mg/24 hour. Patients will be given 1g/Kg of albumin per day, which will be discontinued if CVP is more than 18 cm H2O.
Arm Title
Terlipressin + Albumin
Arm Type
Active Comparator
Arm Description
Continuous IV infusion of NA starting at 0.5 mg/h with doubling of dose after every 4 hours designed to achieve an increase in MAP of at least 10 mmHg or an increase in 4-h urine output of more than 200 ml. When one of these goals was not achieved, the noradrenaline dose was increased every 4 h in steps of 0.5 mg/h, up to the maximum dose of 3 mg/h. Patients will be given 1g/Kg of albumin per day, which will be discontinued if CVP is more than 18 cm H2O.
Intervention Type
Drug
Intervention Name(s)
Nor adrenaline + albumin
Intervention Type
Drug
Intervention Name(s)
Terlipressin + albumin
Primary Outcome Measure Information:
Title
Response to treatment in each intervention group
Description
Complete response: Regression of acute kidney injury stage with reduction of S. Cr within 0.3 mg/dl of baseline (ii) Partial response: Regression of acute kidney injury stage with reduction of S. Cr to ≥0.3 mg/dl above baseline (iii) No response: No regression of acute kidney injury.
Time Frame
14 days
Secondary Outcome Measure Information:
Title
Survival
Time Frame
28 days
Title
Drug related Side effects/complications
Time Frame
28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with acute on chronic liver failure presenting with hepatorenal syndrome Patients consented for the study protocol by signing the informed consent. Exclusion Criteria: Age less than 18 years Decompensated cirrhotics Evidence of chronic kidney disease Patients undergoing renal replacement therapy (hemo-dialysis/renal transplantation). Post liver transplantation patients. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr Vinod Arora, MD
Organizational Affiliation
Institute of Liver and Biliary Sciences
Official's Role
Principal Investigator
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 Response Rate of Noradrenaline vs. Terlipressin in Hepatorenal Syndrome in Patients With Acute on Chronic Liver Failure

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