Comparison between rifaximin vs lactulose for treatment of hepatic encephalopathy

Bio-innova and Synchron Co., Ltd0 个研究点目标入组 80 人开始时间: 2018年5月9日最近更新: 2024年8月19日

适应症

试验速览

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•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 â‰¥ 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 Crâ€™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.

发起方

Bio-innova and Synchron Co., Ltd