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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02321371
Other study ID # ILBS-ACLF-HE-01
Secondary ID
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
Health authority
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

Study Design


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
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