Health Condition 1: null- cirrhotic patients with grade 3 or 4 (West Haven Criteria) hepatic encephalopathy (HE)
Conditions
Sponsors
Abbott India Linited
Eligibility
Inclusion criteria
Inclusion criteria: 1 Patients aged between 18 and 65 years of either gender 2 Patients admitted to the hospital with liver cirrhosis and grade 3 or grade 4 (West Haven Criteria) HE 3 Patients treated with lactulose retention enema within 48 hours of onset of grade 3 or 4 (West Haven Criteria) HE
Exclusion criteria
Exclusion criteria: 1. Patients treated with agents other than lactulose retention enema for grade 3 or 4 (West Haven Criteria) HE. 2 Patients who had significant concomitant diseases that could impair or contribute to the impairment of consciousness 3 Patients who had a major neuropsychiatric illness 4 Patients who had a contraindication to lactulose, including Hypersensitivity to the active substance or to any of the ingredients Galactosaemia Gastrointestinal obstruction digestive perforation or risk of digestive perforation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete reversal of deep-grade (Grade 3 and 4 West-Haven Criteria) HE after administration of lactulose retention enemaTimepoint: at 48 hours | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Grade shift at 24 and 48 hours â?? before and after administration of lactulose retention enema 2) Time to complete reversal of deep-grade (Grade 3 and 4 West-Haven Criteria) HE after administration of lactulose retention enema 3) Mortality after administration of lactulose retention enemaTimepoint: 1) HE grade shift from baseline to 24 and 48 hours post treatment 2) Time to complete reversal of deep-grade (Grade 3 and 4 West Haven Criteria) HE after administration of lactulose retention enema 3) Mortality in patients treated with lactulose retention enema;1) Reduction in blood ammonia level, including time taken for the same, after administration of lactulose retention enema 2) Duration of hospital stayTimepoint: 1) Percentage reduction in blood ammonia level, including time taken for the same after treatment with lactulose retention enema 2) Duration of hospital stay in patients treated with lactulose retention enema | — |
Countries
India
Contacts
Public ContactDr Kaushal Madan
Medanta Medicity
Outcome results
None listed