NCT03645642

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Institute of Liver and Biliary Sciences, India · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hepatic Hydrothorax

Interventions

Type	Name	Description
DRUG	Midodrine	Midodrine 5 mg thrice daily
BIOLOGICAL	Albumin	Albumin 20g/l
DRUG	Diuretics	Diuretics will be continued with an maximum dose of furosemide (160mg) and Aldactone 400 mg.

Timeline

• Start date: 2018-09-30
• Primary completion: 2018-12-31
• Completion: 2018-12-31
• First posted: 2018-08-24
• Last updated: 2020-06-25

Locations

1 site across 1 country: India