Clinical Trial: Rifaximin in Patients With Gastroesophageal Variceal Bleeding
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Efficacy of Rafiximin in Patients With Cirrhotic Gastroesophageal Variceal Hemorrhage: A Single-center Pilot Study
Brief Summary: The purpose of the study is to evaluate the safety and efficacy of Rifaximin in the treatment of cirrhotic gastroesophageal variceal bleeding.
Detailed Summary:
Gastroesophageal variceal bleeding is the most common and life-threatening condition in patients with portal hypertension, which are susceptibility to bacterial infection.
However, the prophylaxis use of antibiotics remained uncertain and lack of high level evidences.
Sponsor: Shanghai Zhongshan Hospital
Current Primary Outcome: Incidence of all clinical adverse events [ Time Frame: 8 weeks ]
Original Primary Outcome: All clinical events [ Time Frame: 8 weeks ]
Current Secondary Outcome:
- Incidence of all clinical adverse events [ Time Frame: 6 months ]The occurrence of rebleeding, ascites fluid infection, hepatorenal syndrome, hepatopulmonary syndrome, portal vein thrombosis, or death in 6 months.
- Changes of intestinal flora [ Time Frame: 2 months ]
- The changes of plasma endotoxins level [ Time Frame: 8 weeks ]
Original Secondary Outcome:
- All clinical events [ Time Frame: 6 months ]
- Changes of intestinal flora [ Time Frame: 2 months ]
- The changes of plasma endotoxins level [ Time Frame: 8 weeks ]
Information By: Shanghai Zhongshan Hospital
Dates:
Date Received: December 10, 2016
Date Started: December 2016
Date Completion: December 2017
Last Updated: December 29, 2016
Last Verified: December 2016