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

Institute of Liver and Biliary Sciences, India

Status: Unknown

Conditions: Hepatopulmonary Syndrome

Treatments: Drug: pentoxifylline and rifaximin; Drug: Pentoxifylline and placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01676597

ILBS-HPS-01

Details and patient eligibility

About

• 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

rifaximin and pentoxifylline

Experimental group

Description:

Tab Rifaximin 400 mg thrice daily + Pentoxifylline 400 mg thrice daily for 12 weeks

Treatment:

Drug: Pentoxifylline and placebo

pentoxifylline and placebo

Active Comparator group

Description:

Tab Pentoxifylline 400 mg thrice daily + Placebo thrice daily for 12 weeks

Treatment:

Drug: pentoxifylline and rifaximin