Pentoxifylline (drug) forHepatopulmonary Syndrome (Liver and lung disease)

Not Applicable

• Conditions: Health Condition 1: K768- Other specified diseases of liver

• Registration Number: CTRI/2022/04/041981
• Lead Sponsor: Institute of Liver and Biliary Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

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 <65years and >20mmHg if Age� 70 years

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 < 70)

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 <50 mmHg)

7.Active bacterial infections, active hepatic encephalopathy

8.Known malignancy including HCC

9.SBP on secondary prophylaxis

10.CKD with creatinine clearance < 30

11.Enrolled in other trials

12.Has a liver transplant option

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 �² at the end of 3 and 6 months from baseline in a subset of patients wherever feasibleTimepoint: 3 and 6 months