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

NCT03645642 — Not applicable, Completed, 8 participants, Institute of Liver and Biliary Sciences, India

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

Registry	NCT03645642
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: none, treatment
Enrollment	8 (Actual)
Sponsor	Institute of Liver and Biliary Sciences, India (Other)
Conditions	Hepatic Hydrothorax
Interventions	Midodrine, Albumin, Diuretics (Drug, biological)
Dates	start 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 in India

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Midodrine	Experimental	Drug: Midodrine; Biological: Albumin; Drug: Diuretics	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.
Albumin with diuretics	Active comparator	Biological: Albumin; Drug: Diuretics	Albumin(20g/l) and diuretics.

Midodrine (Drug): Midodrine 5 mg thrice daily
Albumin (Biological): Albumin 20g/l
Diuretics (Drug): Diuretics will be continued with an maximum dose of furosemide (160mg) and Aldactone 400 mg.

+Outcome measures

Primary outcomes

Change in frequency of thoracentesis. [3 months]

Secondary outcomes

Partial or complete resolution of hepatic hydrothorax [3 months]
Development of Spontaneous Bacterial Empyema [3 Months]
Development of Thorocacocentesis Induced circulatory dysfunction [3 Months]
Drug related adverse events in both arms [3 Months]
Transplant free survival in both groups [3 Months]
Predictors and mechanisms of repeated development of hepatic hydrothorax [3 Months]
Number of patients going for TIPS(Transintrahepatic Portosystemic Shunts) [3 Months]

+Eligibility

Sex: All, ages: 18 Years to 75 Years

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

+Locations (1)

Facility	City	Country	Status
Institute of Liver and Biliary Sciences	New Delhi, National Capital Territory of Delhi	India