Rifaximin in Patients With Gastroesophageal Variceal Bleeding

Cirrhosis Clinical Trial

— RFXM  

Official title:

Efficacy of Rafiximin in Patients With Cirrhotic Gastroesophageal Variceal Hemorrhage: A Single-center Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02991612
• Other study ID #: ZS-CSY-RFXM
• Status: Completed
• Phase: N/A
• Start date: November 25, 2016
• Est. completion date: February 28, 2018

Study information

• Verified date: May 2018
• Source: Shanghai Zhongshan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to evaluate the safety and efficacy of Rifaximin in the treatment of cirrhotic gastroesophageal variceal bleeding.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: February 28, 2018
• Est. primary completion date: December 22, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• 18 y.o. =age=75 y.o.;

• Cirrhotic gastroesophageal variceal bleeding underwent endoscopic treatment (include esophageal varices ligation, endoscopic injection sclerosis and gastric N- butyl-cyanoacrylate injection).

Exclusion Criteria:

• age <18 y.o. or age > 75 y.o.;

• Never had the variceal bleeding episode before;

• Do not have endoscopic treatment;

• Combined with other malignant tumors (not exclude patients with hepatocellular carcinoma who don't need treatment at the moment);

• Known infection after endoscopic treatment (Fever, microbial cultures positive, et al.)

• Massive ascites or combined with other high-risk factors that require prophylaxis use of antibiotics.

• Acute variceal bleeding within 5 days.

• Refuse to participate

Related Conditions & MeSH terms

• Cirrhosis
• Esophageal and Gastric Varices
• Gastrointestinal Hemorrhage
• Hemorrhage

Intervention

Drug:
• Rifaximin
Patients receive Rifaximin 400mg bid for 2 months

Locations

Country	Name	City	State
China	180 Fenglin Road	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Zhongshan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of all clinical adverse events	The occurrence of rebleeding, ascites fluid infection, hepatorenal syndrome, hepatopulmonary syndrome, portal vein thrombosis, or death in 8 weeks	8 weeks
Secondary	Changes of portal vein thrombosis	complete or partial recanalization of thrombosis	2 months
Secondary	Changes of intestinal flora	Metagenomics sequencing	2 months
Secondary	The changes of serum level of cytokines	Cytokines including TNF-a, IL-1ß, IL-2R, IL-6 and IL-10, etc	8 weeks