NCT02321371

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 73 (actual)
• Sponsor: Institute of Liver and Biliary Sciences, India · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute-On-Chronic Liver Failure

Interventions

Type	Name	Description
DRUG	Lactulose + Rifaximin	Lactulose + addition of Rifaximin 400 mg 8th hourly through enteral route
DRUG	Lactulose	Continuation of Lactulose therapy for further 48 hours.

Timeline

• Start date: 2014-10-19
• Primary completion: 2016-01-31
• Completion: 2016-01-31
• First posted: 2014-12-22
• Last updated: 2018-02-08

Locations

1 site across 1 country: India