To Study the Safety and Efficacy of Midodrine With Albumin Versus Albumin Alone in Hepatic Hydrothorax

Study Overview
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Brief Summary
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Hepatic hydrothorax is defined with accumulation of transudate fluid (500 ml) in the pleural cavity in patients with decompensated liver cirrhosis but without cardiopulmonary and pleural diseases. The Prevalence is 5-12% The treatment for hydrothorax is diuretics, repeated thoracocentensis, TIPS and liver transplant.. Midodrine increases effective arterial blood volume and also increases renal perfusion.It has also been used in Refractory ascitis .It has been shown to mobilise ascitis. In patients who are ineligible for TIPS and Liver transplant there is no data on Midodrine and its effects on Hydrothorax in cirrhotics.There are also no guidelines on the use of albumin during Pleural fluid tapping and the dose to be used. This study is being done to assess the safety and efficacy of Midodrine in hydrothorax.

Official Title
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To Study the Safety and Efficacy of Midodrine With Albumin Versus Albumin Alone in Hepatic Hydrothorax- A Pilot Randomised Controlled Trial

Conditions
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Hepatic Hydrothorax

Intervention / Treatment
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* Drug: Midodrine
* Biological: Albumin
* Drug: Diuretics


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with hepatic hydrothorax Patients with age from 18-75 years No evidence of Cardiac and pulmonary disease Exclusion Criteria: Renal failure ( Creatinine>2.5mg/dl) Gastrointestinal bleeding Spontaneous bacterial empyema/ Peritonitis Patients with urinary retention Intrinsic advanced pulmonary disease (CXR, HRCT thorax) Cardiovascular disease (Electrocardiogram, 2D Echo) Systemic arterial hypertension Presence of hepatocellular carcinoma or portal vein thrombosis, Budd chiari syndrome Patients with active untreated sepsis Pregnancy Patients with hepatic encephalopathy Patients eligible for TIPS No use of drugs affecting systemic hemodynamics prior to 7 day of enrollment

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Midodrine<br>Midodrine (5 mg TDS) along with albumin(20g/l) and diuretics. The dose of Midodrine will titrated according to the Mean arterial pressure (75-90mmhg). The dose will be increased to a maximum of 12.5 mg thrice daily. | Drug: Midodrine<br>* Midodrine 5 mg thrice daily<br>Biological: Albumin<br>* Albumin 20g/l<br>Drug: Diuretics<br>* Diuretics will be continued with an maximum dose of furosemide (160mg) and Aldactone 400 mg.<br>|
| Active Comparator: Albumin with diuretics<br>Albumin(20g/l) and diuretics. | Biological: Albumin<br>* Albumin 20g/l<br>Drug: Diuretics<br>* Diuretics will be continued with an maximum dose of furosemide (160mg) and Aldactone 400 mg.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in frequency of thoracentesis. |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Partial or complete resolution of hepatic hydrothorax |  | 3 months | 
| Development of Spontaneous Bacterial Empyema |  | 3 Months | 
| Development of Thorocacocentesis Induced circulatory dysfunction |  | 3 Months | 
| Drug related adverse events in both arms |  | 3 Months | 
| Transplant free survival in both groups |  | 3 Months | 
| Predictors and mechanisms of repeated development of hepatic hydrothorax |  | 3 Months | 
| Number of patients going for TIPS(Transintrahepatic Portosystemic Shunts) |  | 3 Months |