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

Acute-On-Chronic Liver Failure Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02321371
• Other study ID #: ILBS-ACLF-HE-01
• Status: Completed
• Phase: N/A
• First received: December 17, 2014
• Last updated: February 7, 2018
• Start date: October 19, 2014
• Est. completion date: January 31, 2016

Study information

• Verified date: January 2017
• Source: Institute of Liver and Biliary Sciences, India
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: January 31, 2016
• Est. primary completion date: January 31, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute-On-Chronic Liver Failure
• End Stage Liver Disease
• Hepatic Encephalopathy
• Liver Failure

Intervention

Drug:
• Lactulose + Rifaximin
Lactulose + addition of Rifaximin 400 mg 8th hourly through enteral route
• Lactulose
Continuation of Lactulose therapy for further 48 hours.

Locations

Country	Name	City	State
India	Institute of Liver & Biliary Sciences	New Delhi	Delhi

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Liver and Biliary Sciences, India

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction of ammonia level to <70 mcg/dL within 72 hours of the ammonia reduction treatment.		3 days
Secondary	Reduction of ammonia level to at least 50% of the baseline value within 72 hours.		3 days
Secondary	Duration of hepatic encephalopathy post-inclusion.	10 days after enrollment or 7 days after achieving primary endpoint, whichever is shorter.	10 days
Secondary	Improvement in hepatic encephalopathy from grade III-IV to II-I at any time within 72 hours of treatment.		3 days
Secondary	Liver disease related and overall mortality.	10 days after enrollment or 7 days after achieving primary endpoint, whichever is shorter.	10 days
Secondary	Duration of ICU stay.	10 days after enrollment or 7 days after achieving primary endpoint, whichever is shorter.	10 days