Efficacy of Pentoxifylline and Rifaximin Combination in Pentoxifylline Refractory Clinical and Subclinical Hepatopulmonary Syndrome | NCT01676597 | Trialant
Unknown statusInterventionalNot ApplicableUpdated Dec 17, 2013
Efficacy of Pentoxifylline and Rifaximin Combination in Pentoxifylline Refractory Clinical and Subclinical Hepatopulmonary Syndrome
ClinicalTrials.gov ID
NCT01676597
Lead Sponsor
Institute of Liver and Biliary Sciences, IndiaOTHER
Overall Status
Unknown status
Study Type
Interventional
Phase
Not Applicable
Enrollment
80Estimated
Last Update Posted
Dec 17, 2013Estimated
Start Date
Sep 2012
Primary Completion Date
Sep 2014Estimated
Completion Date
Sep 2014Estimated
Brief 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.
Hepatopulmonary Syndrome
pentoxifylline and rifaximin
Pentoxifylline and placebo
Ages Eligible for Study
Adult (18-64)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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)
Intrapulmonary vascular dilatations (IPVDs) diagnosed on contrast echocardiogram (CE)
AaDO2 > 15 mm Hg on standing room air arterial blood gas (ABG)
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
Primary Purpose
Treatment
Allocation
Randomized
Interventional Model
Parallel Assignment
Masking
None (Open Label)
Dr Naveen Kumar, MDContact
naveenilbsdelhi@gmail.com011-46300000
Dr Ankit BhardwajContact
bhardwaj.ankit3@gmail.com011-46300000 ext. 1032
Institute of Liver and Biliary SciencesRecruiting
New Delhi, National Capital Territory of Delhi 110070, India
Dr Naveen, MDContact
naveenilbsdelhi@gmail.com011-46300000
Dr Ankit BhardwajContact
bhardwaj.ankit3@gmail.com011-46300000 ext. 1032
Lead Sponsor
Institute of Liver and Biliary Sciences, IndiaOTHER