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

Hepatic Hydrothorax Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03645642
• Other study ID #: ILBS-Cirrhosis-18
• Status: Completed
• Phase: N/A
• Start date: September 30, 2018
• Est. completion date: December 31, 2018

Study information

• Verified date: November 2019
• Source: Institute of Liver and Biliary Sciences, India
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Hepatic Hydrothorax
• Hydrothorax

Intervention

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.

Locations

Country	Name	City	State
India	Institute of Liver and Biliary Sciences	New Delhi	Delhi

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Liver and Biliary Sciences, India

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in frequency of thoracentesis.		3 months
Secondary	Partial or complete resolution of hepatic hydrothorax		3 months
Secondary	Development of Spontaneous Bacterial Empyema		3 Months
Secondary	Development of Thorocacocentesis Induced circulatory dysfunction		3 Months
Secondary	Drug related adverse events in both arms		3 Months
Secondary	Transplant free survival in both groups		3 Months
Secondary	Predictors and mechanisms of repeated development of hepatic hydrothorax		3 Months
Secondary	Number of patients going for TIPS(Transintrahepatic Portosystemic Shunts)		3 Months