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Effect of Goal Directed Ammonia Lowering Therapy in Acute on Chronic Liver Failure Patients With Hepatic Encephalopathy.

Primary Purpose

Acute-On-Chronic Liver Failure

Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Lactulose + Rifaximin
Lactulose
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 - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age 18 years and above
  2. Patients with ACLF with grade III/IV HE

Exclusion Criteria:

  1. Patients with prior decompensation
  2. Grade I,II HE
  3. Chronic HE
  4. CV stroke
  5. Patients with ammonia level <70 mcg/dL
  6. Patients with Septic shock
  7. Pregnant lady

Sites / Locations

  • Institute of Liver & Biliary Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Lactulose + Rifaximin

Lactulose therapy

Arm Description

Continuation of Lactulose + addition of Rifaximin 400 mg 8th hourly through enteral route.

Outcomes

Primary Outcome Measures

Reduction of ammonia level to <70 mcg/dL within 72 hours of the ammonia reduction treatment.

Secondary Outcome Measures

Reduction of ammonia level to at least 50% of the baseline value within 72 hours.
Duration of hepatic encephalopathy post-inclusion.
10 days after enrollment or 7 days after achieving primary endpoint, whichever is shorter.
Improvement in hepatic encephalopathy from grade III-IV to II-I at any time within 72 hours of treatment.
Liver disease related and overall mortality.
10 days after enrollment or 7 days after achieving primary endpoint, whichever is shorter.
Duration of ICU stay.
10 days after enrollment or 7 days after achieving primary endpoint, whichever is shorter.

Full Information

First Posted
December 17, 2014
Last Updated
February 7, 2018
Sponsor
Institute of Liver and Biliary Sciences, India
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1. Study Identification

Unique Protocol Identification Number
NCT02321371
Brief Title
Effect of Goal Directed Ammonia Lowering Therapy in Acute on Chronic Liver Failure Patients With Hepatic Encephalopathy.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
October 19, 2014 (Actual)
Primary Completion Date
January 31, 2016 (Actual)
Study Completion Date
January 31, 2016 (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
In this study, all patients with ACLF (Acute on Chronic Liver Failure) with grade III/IV HE (Hepatic Encephalopathy) getting admitted in our institute will be enrolled after the fulfilment of inclusion/exclusion criteria and consent of the patient's attendants. Investigation of the patient (as mentioned in the proforma) will be done. Intervention step 1: liq Lactulose 100 mL stat followed by 30 mL/ hourly through NG/NJ route + Lactulose enema 3rd hourly - till 4 time soft stool is passed, then 30 mL through enteral route 6th hourly (If patient has no bowel sounds, only enema will be given) Intervention step 2: (after 24 hours of introduction of step 1, if no rapid reduction in ammonia to <70mcg/dL) Randomization to L or R arm R Arm (Addition of Rifaximin) Continuation of Lactulose + addition of Rifaximin 400 mg 8th hourly through enteral route L Arm (Lactulose only) Continuation of Lactulose therapy for further 48 hours.

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
73 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lactulose + Rifaximin
Arm Type
Experimental
Arm Description
Continuation of Lactulose + addition of Rifaximin 400 mg 8th hourly through enteral route.
Arm Title
Lactulose therapy
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Lactulose + Rifaximin
Intervention Description
Lactulose + addition of Rifaximin 400 mg 8th hourly through enteral route
Intervention Type
Drug
Intervention Name(s)
Lactulose
Intervention Description
Continuation of Lactulose therapy for further 48 hours.
Primary Outcome Measure Information:
Title
Reduction of ammonia level to <70 mcg/dL within 72 hours of the ammonia reduction treatment.
Time Frame
3 days
Secondary Outcome Measure Information:
Title
Reduction of ammonia level to at least 50% of the baseline value within 72 hours.
Time Frame
3 days
Title
Duration of hepatic encephalopathy post-inclusion.
Description
10 days after enrollment or 7 days after achieving primary endpoint, whichever is shorter.
Time Frame
10 days
Title
Improvement in hepatic encephalopathy from grade III-IV to II-I at any time within 72 hours of treatment.
Time Frame
3 days
Title
Liver disease related and overall mortality.
Description
10 days after enrollment or 7 days after achieving primary endpoint, whichever is shorter.
Time Frame
10 days
Title
Duration of ICU stay.
Description
10 days after enrollment or 7 days after achieving primary endpoint, whichever is shorter.
Time Frame
10 days

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: Age 18 years and above Patients with ACLF with grade III/IV HE Exclusion Criteria: Patients with prior decompensation Grade I,II HE Chronic HE CV stroke Patients with ammonia level <70 mcg/dL Patients with Septic shock Pregnant lady
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr Tanmay Vyas, MD
Organizational Affiliation
Institute of Liver and Biliary Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute of Liver & Biliary Sciences
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110070
Country
India

12. IPD Sharing Statement

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Effect of Goal Directed Ammonia Lowering Therapy in Acute on Chronic Liver Failure Patients With Hepatic Encephalopathy.

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