drugset / Trial / NCT03645642

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

NCT03645642

RandomizedParallel-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2018-09-30
Primary completion
2018-12-31
Completion
2018-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Midodrine Small molecule 5 mg
Background Albumin Protein / enzyme biologic 20 mg/ml
Background Furosemide Other / unclassified 160 mg
Background Spironolactone Small molecule 400 mg