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OpenTrials
Completed

NCT Number: NCT02321371

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

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.

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Key information

Conditions

Acute-On-Chronic Liver Failure Digestive System Diseases Hepatic Insufficiency Liver Diseases Liver Failure Liver Failure, Acute

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute of Liver & Biliary Sciences

New Delhi, National Capital Territory of Delhi, 110070, India

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lactulose + Rifaximin

Drug

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

Lactulose

Drug

Continuation of Lactulose therapy for further 48 hours.

Primary outcomes

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

    Time frame: 3 days

Secondary outcomes

  1. Reduction of ammonia level to at least 50% of the baseline value within 72 hours.

    Time frame: 3 days

  2. Duration of hepatic encephalopathy post-inclusion.

    Time frame: 10 days

    10 days after enrollment or 7 days after achieving primary endpoint, whichever is shorter.

  3. Improvement in hepatic encephalopathy from grade III-IV to II-I at any time within 72 hours of treatment.

    Time frame: 3 days

  4. Liver disease related and overall mortality.

    Time frame: 10 days

    10 days after enrollment or 7 days after achieving primary endpoint, whichever is shorter.

  5. Duration of ICU stay.

    Time frame: 10 days

    10 days after enrollment or 7 days after achieving primary endpoint, whichever is shorter.

Sponsors and collaborators

Lead sponsor

Institute of Liver and Biliary Sciences, India

Other

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Dec 22, 2014
Registry last updated
Feb 8, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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