Health Condition 1: K768- Other specified diseases of liver
Conditions
Interventions
Intervention1: Pentoxifylline: Dose: 400mg OD x 1 week, 400mg BD x 1 week then increased to 400mg TDS and continued
Route: Oral
Control Intervention1: Placebo: Placebo
Sponsors
Institute of Liver and Biliary Sciences
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age 18 ââ?¬â?? 70 years 2. Evidence of portal hypertension 3. Intrapulmonary vascular dilatation in the form of shunting diagnosed on contrast echocardiogram 4. AaPO2 > 15mmHg on seated room air (ABG) if age 20mmHg if Ageââ?°Â¥ 70 years
Exclusion criteria
Exclusion criteria: 1. Child C cirrhosis with CTP > 10 or with refractory ascites 2. Intrinsic significant cardiopulmonary disease i. PFT showing severe obstructive ventilatory defect (FEV1/FVC ii. Hepatic hydrothorax, Portopulmonary hypertension iii. Moderate and severe left ventricular systolic dysfunction iv. Inability to perform Pulmonary function test v. Intracardiac shunting 3. Current use of exogenous nitrates 4. Patients already on pentoxifylline 5. Prior intolerance to pentoxifylline 6. Very severe cases of HPS (A-aO2 gradient � 15mm Hg, PO2 7. Active bacterial infections, active hepatic encephalopathy 8. Known malignancy including HCC 9. SBP on secondary prophylaxis 10. CKD with creatinine clearance 11. Enrolled in other trials 12. Has a liver transplant option
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement in AaPO2 gradient by at least 5mmHg or to a value less than 15mm Hg at the end of 6 months from baselineTimepoint: 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Decrease in grading of intrapulmonary shunting at the end of 3 and 6 months, from baseline as assessed by saline contrast echocardiographyTimepoint: 3 and 6 months;2. Improvement in Pulmonary function test and 6-minute walk test at the end of 3 and 6 months from baselineTimepoint: 3 and 6 months;Change in DLCO fraction of exhaled NO after 3 and 6 months from baselineTimepoint: 3 and 6 months;Change in inflammatory markers - TNF alpha levels, vWF, ET-1, IL-6, S-1-P levels at the end of 3 and 6 months from baselineTimepoint: 3 and 6 months;Change in seated and supine saturation and PaO2 at 3 and 6 months from baselineTimepoint: 3 and 6 months;Change in VEGFR-3, iNOS, eNOS and IL-1 Ã?² at the end of 3 and 6 months from baseline in a subset of patients wherever feasibleTimepoint: 3 and 6 months | — |
Countries
India
Contacts
Public ContactDr Chitranshu Vashishtha
Institute of Liver and Biliary Sciences
Outcome results
None listed