Status:
UNKNOWN
Efficacy and Safety of Pentoxifylline in Improving Oxygenation in Hepatopulmonary Syndrome
Lead Sponsor:
Institute of Liver and Biliary Sciences, India
Conditions:
Hepatopulmonary Syndrome
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
The triad of liver disease, arterial hypoxia, and extensive pulmonary vascular dilatation is known as the hepatopulmonary syndrome (HPS). The prevalence of this syndrome ranges from 10% to 30% in peop...
Detailed Description
Hypothesis Investigator hypothesize that pentoxifylline in hepatopulmonary syndrome would improve oxygenation by inhibiting TNF alpha and thereby reducing macrophage, endothelium induced NO production...
Eligibility Criteria
Inclusion
- Age 18 - 70 years
- Evidence of portal hypertension
- Intrapulmonary vascular dilatation in the form of shunting diagnosed on contrast echocardiogram
- AaPO2 \> 15mmHg on seated room air (ABG) if age \<65years and \>20mmHg if Age≥ 70 years
Exclusion
- Child C cirrhosis with CTP \> 10 or with refractory ascites
- Intrinsic significant cardiopulmonary disease
- PFT indicating severe obstructive ventilatory defect (FEV1/FVC \< 70)
- Hepatic hydrothorax, Portopulmonary hypertension
- Moderate and severe left ventricular systolic dysfunction
- Inability to perform Pulmonary function test
- Intracardiac shunting
- Current use of exogenous nitrates
- Patients already on pentoxifylline
- Prior intolerance to pentoxifylline
- Very severe cases of HPS (A-aO2 gradient ≥ 15mm Hg, PO2 \<50 mmHg)
- Active bacterial infections, active hepatic encephalopathy
- Known malignancy including HCC
- SBP on secondary prophylaxis
- CKD with creatinine clearance \< 30
- Enrolled in other trials
- Has a liver transplant option
Key Trial Info
Start Date :
May 5 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2023
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT05373134
Start Date
May 5 2022
End Date
April 30 2023
Last Update
May 13 2022
Active Locations (1)
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1
Institute of Liver & Biliary Sciences
New Delhi, National Capital Territory of Delhi, India, 110070