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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Midodrine | Experimental | 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. |
|
| Albumin with diuretics | Active Comparator | Albumin(20g/l) and diuretics. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Midodrine | Drug | Midodrine 5 mg thrice daily |
| |
| Albumin |
| Measure | Description | Time Frame |
|---|---|---|
| Change in frequency of thoracentesis. | 3 months |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Liver and Biliary Sciences | New Delhi | National Capital Territory of Delhi | 110070 | India |
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| ID | Term |
|---|---|
| D008879 | Midodrine |
| D000418 | Albumins |
| D004232 | Diuretics |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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| Biological |
Albumin 20g/l |
|
| Diuretics | Drug | Diuretics will be continued with an maximum dose of furosemide (160mg) and Aldactone 400 mg. |
|
| 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 |
| D000588 |
| Amines |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D045283 | Natriuretic Agents |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |