Health Condition 1: K740- Hepatic fibrosis
Conditions
Interventions
Intervention1: LOLA arm: Tab Rifaximin 550 mg BD + Syp Lactulose 30 ml every 6 hours to acheive 2-3 loose stools/d + Infusion of 2.5ml/hr of L-Ornithine L-Aspartate + Standard management therapy
Contr
Sponsors
Dr Shalimar
Eligibility
Inclusion criteria
Inclusion criteria: 1) Patients with Overt HE (more than grade II)
Exclusion criteria
Exclusion criteria: 1) Age 65 years 2) Acute liver failure 3) Serum creatinine > 1.5 4) Active alcohol consumption over the past 4 weeks 5) Infections other than SBP, e.g. pneumonia, frank sepsis 6) Ileus, intestinal obstruction 7) Hepatocellular carcinoma 8) Advanced cardiac or pulmonary disease 9) Underlying chronic kidney disease 10) Associated psychiatric illness 11) Pregnant or lactating women 12) Metabolic encephalopathy 13) Degenerative neurological disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement in HE gradesto grade 0 in group 1 as compared to group 2 over a period of 7 daysTimepoint: Improvement in HE gradesto grade 0 in group 1 as compared to group 2 over a period of 7 days | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) The rate of recovery of HE between the 2 study groups over 7 days 2) Development of new OF over 7 days 3) Development of new infections over 7 days 4) Mortality over 7 days and 28 days 5) Length of hospital stay 6) Change in arterial ammonia levels over 7 days 7) Change in endotoxin levels over 7 days 8) Change in proinflammatory and anti-inflammatory cytokines over 7 days Timepoint: 7 days | — |
Countries
India
Contacts
Public ContactPiyush Pathak
AIl india Institute of Medical seciences
Outcome results
None listed