Acute-On-Chronic Liver Failure, Hepatic Encephalopathy
Conditions
Keywords
branched chain amino acids, hepatic encephalopathy, lactulose, acute on chronic liver failure, bispectral index
Brief summary
This study analyses the effect of intravenous branched chain amino acids (BCAA) on overt HE in patients with ACLF. The investigators plan to study the efficacy of combining intravenous BCAA with lactulose versus lactulose alone in the medical management of overt HE in patients with ACLF and its impact on overall survival and improvement in grade of HE.
Detailed description
Acute on chronic liver failure (ACLF) is a distinct clinical entity in the spectrum of chronic liver disease associated with high short term mortality. Hepatic encephalopathy (HE) is commonly seen in patients with ACLF and its treatment mainly involves non-absorbable disaccharides (lactulose/lactitol).Treatment of HE in ACLF is based on extrapolation of data available from cirrhotic patients. No studies have compared different treatment options for HE in patients with ACLF.
Interventions
Intravenous branched chain amino acids will be given for 3 days to patients in experimental arm
DRUGLactulose
Oral lactulose will be given to patients in both arms
Sponsors
Post Graduate Institute of Medical Education and Research, Chandigarh
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Prospective interventional cohort study
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Age 18-75 years 2. Either gender 3. Patients with ACLF (CANONIC definition) of any aetiology with HE ≥grade 2 as per West-Haven Criteria or Hepatic encephalopathy scoring algorithm (HESA)
Exclusion criteria
1. Those who do not consent to participate in the study 2. Patients with structural brain lesions or stroke 3. Inability to obtain informed consent from patient or relatives 4. Severe preexisting cardiopulmonary disease 5. Renal dysfunction (S. Creatinine ≥ 2mg/dL) 6. Pregnancy/Lactation 7. Post liver transplant patients 8. HIV infection 9. Patients who are on psychoactive drugs, like sedatives or antidepressants 10. Patients who are too sick to carry out the protocol As the study was carried out during the peak of the COVID-19, patients who developed COVID-19 after randomization were excluded from the analysis as they were shifted to dedicated COVID-19 ICU's.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvement of Survival | At day day 28 | All cause Mortality assessment |
| Improvement of encephalopathy by ≥ 1 grade | 72 hours | Improvement in hepatic encephalopathy |
Secondary
| Measure | Time frame |
|---|---|
| Reduction in level of ammonia | 48 and 72 hours |
| Reduction of consciousness recovery time among survivors | 30 days |
| Prolongation of time to death among non-survivors | 30 days |
| Prevention/reduction of cerebral edema based on optic nerve sheath diameter | 72 hours |
Countries
India
Outcome results
None listed