Comparison between rifaximin vs lactulose for treatment of hepatic encephalopathy
- Conditions
- treatment of hepatic encephalopathyhepatic encephalopathyrifaximinlactulose
- Registration Number
- TCTR20180509001
- Lead Sponsor
- Bio-innova and Synchron Co., Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 80
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;
3.1Patients are in causing of the Gastrointestinal Hemorrhage which should have stopped bleeding before recruitment.
3.2Patients are in causing of the spontaneous bacterial peritonitis or septicemia which should have taken antibiotics for infectious treatment before recruitment.
3.3Patients have been received a lactulose but less than 1 day prior to enrollment.
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 < 7 gm/dl, Severe Electrolyte imbalance i.e. Hyponatremia (< 125 mmol/L), Hypercalcemia (>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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method adverse drug event 0,3,5,10 days after drug administration mortality rate, length of hospital stay