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 ]

The occurrence of rebleeding, ascites fluid infection, hepatorenal syndrome, hepatopulmonary syndrome, portal vein thrombosis, or death in 8 weeks


Original Primary Outcome: All clinical events [ Time Frame: 8 weeks ]

The occurrence of rebreeding, ascites fluid infection, hepatorenal syndrome, hepatopulmonary syndrome, portal vein thrombosis, or death.


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