Hemodynamic Response of Rifaximin plus Non-selective ß-blocker versus non-selective ß-blocker monotherapy in Cirrhotic Patients with esophageal varices

Hemodynamic Response of Rifaximin plus Non-selective ß-blocker versus non-selective ß-blocker monotherapy in Cirrhotic Patients with esophageal varices.

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CRIS

Registry ID

KCT0000788

Enrollment

140

Registered

2013-07-11

Start date

2013-07-15

Completion date

Unknown

Last updated

2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : After measurement of baseline HVPG, patients will be randomized to treatment group of Rifaximin + Propranolol or Propranolol + Placebo. And 6 weeks after treatment, follow-up measurement of HVP

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Liver cirrhosis:diagnosed based on histology or unequivocal clinical, sonographic, and laboratory findings 2.Esophageal varices, F2 or F3 3.Hepatic venous pressure gradient > 12mmHg 4.Informed consent

Exclusion criteria

Exclusion criteria: 1.Shock status requiring vasopressor 2.Active infection, for example Spontaneous bacterial peritonitis 3.Acute renal failure patients of any cause 4.Clinically relevant coronary artery disease(NYHA functional angina classification III/IV),congestive heart failure NYHA III/IV), clinically relevant cardiomyopathy, history of myocardial infarction in the past 12 months 5.Poorly controlled hypertension (BP 150/100mmHg) 6.Hepatocellular carcinoma 7.History of another primary malignancy = 3years 8.Medical or psychological conditions that would not permit the subject to complete thte study or sign informed consent 9.Pregnancy or lactation period 10.Serum creatinine ? 6mg/dL 11.Involvement in the conduct of other study within 30 days 12.Known hypersensitivity to Rifaximin or propranolol 13.Dysarrhythmia, inappropriate for study on investigator's judgment

Design outcomes

Primary

Measure	Time frame
Hepatic vein pressure gradient(HVPG)	—

Secondary

Measure	Time frame
occurence of gastrointestinal bleeding	—

Countries

Korea, Republic of

Contacts

Public ContactMoon Young Kim

Yonsei University, Wonju Severance Christian Hospital

Outcome results