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

Institute of Liver and Biliary Sciences, India

Status: Completed

Conditions: Hepatic Hydrothorax

Treatments: Drug: Midodrine; Drug: Diuretics; Biological: Albumin

Study type: Interventional

Funder types: Other

Identifiers

NCT03645642

ILBS-Cirrhosis-18

Details and patient eligibility

About

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.

Enrollment: 8 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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8 participants in 2 patient groups

Midodrine

Experimental group

Description:

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.

Treatment:

Drug: Diuretics

Drug: Midodrine

Biological: Albumin

Albumin with diuretics

Active Comparator group

Description:

Albumin(20g/l) and diuretics.

Treatment:

Drug: Diuretics

Biological: Albumin