Pilot Study of Pentoxifylline for Hepatopulmonary Syndrome

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-06-30

Study Completion Date

2006-10-31

Brief Summary

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The Hepatopulmonary syndrome (HPS) results from intrapulmonary microvascular dilatation that impairs arterial oxygenation in the setting of cirrhosis or portal hypertension. As many as 10-20% of cirrhotics being evaluated for orthotopic liver transplantation (OLT) have advanced HPS and mortality is greater in those with HPS than in those without HPS. Currently, OLT is the only effective treatment, although post-operative mortality in HPS is increased relative to cirrhotic patients without HPS, with a one-year survival of between 68-80 %. Therefore, an effective medical therapy for advanced HPS could improve both pre-operative and post-operative mortality.

Recent work in experimental models of HPS has revealed that both nitric oxide synthase-derived nitric oxide and heme oxygenase-derived carbon monoxide cause intrapulmonary vasodilatation. These alterations appear to be driven in part by TNF-α modulation of pulmonary blood flow and intravascular monocyte accumulation. Pentoxifylline is a nonspecific phosphodiesterase inhibitor with inhibitory effects on TNF-α and has recently been shown to be beneficial in patients with severe alcoholic hepatitis where TNF-α overproduction contributes to liver injury. In experimental HPS, pentoxifylline administration also decreases the severity of oxygenation abnormalities. However, pentoxifylline therapy has been associated with dose limiting side effects in patients with liver disease and the tolerability of pentoxifylline in cirrhotic patients with advanced HPS is unknown. Therefore, this open label single arm clinical trial was designed to evaluate the efficacy and tolerability of 8 weeks of pentoxifylline in cirrhotic patients with advanced HPS being considered for OLT.

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Detailed Description

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Conditions

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Hepatopulmonary Syndrome

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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single

Group Type EXPERIMENTAL

pentoxifylline

Intervention Type DRUG

pentoxifylline extended release 800mg PO TID for 8 weeks

Interventions

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pentoxifylline

pentoxifylline extended release 800mg PO TID for 8 weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patient undergoing liver transplantation evaluation for cirrhosis
* HPS (positive contrast echocardiography, hypoxemia, no other cause)
* PaO2 \< 65mmHg
* ability and willingness to give informed consent

Exclusion Criteria

* Patients under the age of 19
* active bacterial infections
* known malignancy
* intrinsic cardiopulmonary disease
* known intolerance to pentoxifylline

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No