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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title:

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.


Detailed Summary:
Sponsor: Institute of Liver and Biliary Sciences, India

Current Primary Outcome: Reduction of ammonia level to <70 mcg/dL within 72 hours of the ammonia reduction treatment. [ Time Frame: 3 days ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Reduction of ammonia level to at least 50% of the baseline value within 72 hours. [ Time Frame: 3 days ]
  • Duration of hepatic encephalopathy post-inclusion. [ Time Frame: 10 days ]
    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. [ Time Frame: 3 days ]
  • Liver disease related and overall mortality. [ Time Frame: 10 days ]
    10 days after enrollment or 7 days after achieving primary endpoint, whichever is shorter.
  • Duration of ICU stay. [ Time Frame: 10 days ]
    10 days after enrollment or 7 days after achieving primary endpoint, whichever is shorter.


Original Secondary Outcome: Same as current

Information By: Institute of Liver and Biliary Sciences, India

Dates:
Date Received: December 17, 2014
Date Started: October 2014
Date Completion:
Last Updated: January 26, 2017
Last Verified: January 2017