Efficacy of Pentoxifylline and Rifaximin Combination in Pentoxifylline Refractory Clinical and Subclinical Hepatopulmonary Syndrome

• Status: Unknown status
• Trial end date: 2014-09-01
• Target enrollment: 0
• Participant gender: All

Summary

• The study will be a prospective open labelled double blinded randomized controlled study.

• The study will be conducted on patients admitted to Department of Hepatology from 2012 to 2014 at Institute of Liver and Biliary Sciences, New Delhi

• Patients diagnosed as having clinical or subclinical hepatopulmonary syndrome will be started on oral pentoxifylline therapy 400 mg thrice daily for 12 weeks.

• Patients not responding to this therapy will be given divided into 2 arms with one arm receiving additional Tab Rifaximin 400 mg thrice daily or placebo for 12 weeks.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Institute of Liver and Biliary Sciences, India
• Treatments: Pentoxifylline; Rifamycins; Rifaximin

Criteria

Inclusion Criteria:

1. Evidence of portal hypertension (esophagogastric varices or portal hypertensive gastropathy identified on esophagogastroduodenoscopy, and/or varices seen on computerized tomography scan or ultrasound, and/or splenomegaly with no other explanation, and/or ascites with no other explanation)

2. Intrapulmonary vascular dilatations (IPVDs) diagnosed on contrast echocardiogram (CE)

3. AaDO2 > 15 mm Hg on standing room air arterial blood gas (ABG)

4. Ability and willingness to give informed consent

Exclusion Criteria:

• Age < 18 or > 64

• Intrinsic significant cardiopulmonary disease

• Inability to perform pulmonary function tests

• Moderate to severe Pulmonary hypertension

• Advanced hepatic encephalopathy

• Inadequate echocardiographic window to allow for accurate transthoracic contrast echocardiography

• Antibiotic use within the last one month

• Listed for liver transplant in next 4 weeks

• Current use of exogenous nitrates

• Active bacterial infections

• Known malignancy

• Known intolerance to Pentoxifylline or rifaximin