treatment of hepatic encephalopathy hepatic encephalopathy rifaximin lactulose
Conditions
Interventions
randomized double blind,
Comparison between rifaximin vs lactulose for treatment of hepatic encephalopathy,randomized double blind,
Comparison between rifaximin vs lactulose for treatment of hepatic encephalopathy
Experimental Drug,Active Comparator Drug
rifaximin,lactulose
Sponsors
Bio-innova and Synchron Co., Ltd
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patients aged over 18 years. 2. Patients with diagnosis as Cirrhosis that its associated to the Hepatic encephalopathy and the severity of conn score ≥ 1. 3. Patients are in condition of Hepatic encephalopathy but have any supportive factors as follows; 3.1 Patients are in causing of the Gastrointestinal Hemorrhage which should have stopped bleeding before recruitment. 3.2 Patients are in causing of the spontaneous bacterial peritonitis or septicemia which should have taken antibiotics for infectious treatment before recruitment. 3.3 Patients have been received a lactulose but less than 1 day prior to enrollment.
Exclusion criteria
Exclusion criteria: 1. Patients have planned to perform the liver transplantation within 1 month prior to enrollment. 2. Patient who in recurrent of Hepatic encephalopathy within 3 months prior to enrollment. 3. Patients have received treatment with Portosystemic shunting i.e. Trans jugular intrahepatic portosystemic shunt (TIPS) within 3 months 4. Patients are in a chronic renal insufficiency which the serum Cr’s result is upper than 2.5 mg/dl or Patients are in acute kidney injury that requiring the dialysis treatment. 5. Patients have a history within 1 year of Central nervous injury or as Cerebrovascular disease. 6. Patients have been a non-epileptic seizure. 7. Patients have diagnosed as Hepatocellular carcinoma. 8. Patients have diagnosed any Cancers, except the Skin cancer is resolved by the surgery method within 1 year. 9. Patients have been a Major psychiatric illness. 10. Patients have been any severe comorbidity i.e. Hemodynamic compromise, Respiratory insufficiency, Severe anemia with the hemoglobin 10 gm/dl), Hypokalemia (< 2.5 mmol/L). 11. Patients are in temporality not feasible to get an oral administration. 12. Patients have a history of the severe adverse drug reaction.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| improvement of clinical syndrome of hepatic encephalopathy 0,3,5,10 days after drug administration improvement of clinical syndrome of hepatic encephalopathy,improvement of clinical syndrome of hepatic encephalopathy 0,3,5,10 days after drug administration conn score, asterixis grading | — |
Secondary
| Measure | Time frame |
|---|---|
| adverse drug event 0,3,5,10 days after drug administration mortality rate, length of hospital stay | — |
Countries
thailand
Contacts
Public ContactWatcharasak Chotiyaputta
Faculty of Medicine Siriraj Hospital, Mahidol University
Outcome results
None listed