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

Institute of Liver and Biliary Sciences, India8 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hepatic Hydrothorax

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Change in frequency of thoracentesis.

Time frame: 3 months

Secondary Outcomes

Partial or complete resolution of hepatic hydrothorax

Time frame: 3 months

Development of Spontaneous Bacterial Empyema

Time frame: 3 Months

Development of Thorocacocentesis Induced circulatory dysfunction

Time frame: 3 Months

Drug related adverse events in both arms

Time frame: 3 Months

Transplant free survival in both groups

Time frame: 3 Months

Predictors and mechanisms of repeated development of hepatic hydrothorax

Time frame: 3 Months

Number of patients going for TIPS(Transintrahepatic Portosystemic Shunts)

Time frame: 3 Months

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes