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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-30

Study Completion Date

2018-12-31

Brief Summary

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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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Detailed Description

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Conditions

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Hepatic Hydrothorax

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Midodrine

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.

Group Type EXPERIMENTAL

Midodrine

Intervention Type DRUG

Midodrine 5 mg thrice daily

Albumin

Intervention Type BIOLOGICAL

Albumin 20g/l

Diuretics

Intervention Type DRUG

Diuretics will be continued with an maximum dose of furosemide (160mg) and Aldactone 400 mg.

Albumin with diuretics

Albumin(20g/l) and diuretics.

Group Type ACTIVE_COMPARATOR

Albumin

Intervention Type BIOLOGICAL

Albumin 20g/l

Diuretics

Intervention Type DRUG

Diuretics will be continued with an maximum dose of furosemide (160mg) and Aldactone 400 mg.

Interventions

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Midodrine

Midodrine 5 mg thrice daily

Intervention Type DRUG

Albumin

Albumin 20g/l

Intervention Type BIOLOGICAL

Diuretics

Diuretics will be continued with an maximum dose of furosemide (160mg) and Aldactone 400 mg.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No