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

Sponsor

Institute of Liver and Biliary Sciences, India (Other)

Overall Status

Completed

CT.gov ID

NCT03645642

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

2.6

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Hepatic Hydrothorax	Drug: Midodrine Biological: Albumin Drug: Diuretics	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

8 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Sep 30, 2018

Actual Primary Completion Date :

Dec 31, 2018

Actual Study Completion Date :

Dec 31, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	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.
Active Comparator: Albumin with diuretics Albumin(20g/l) and diuretics.	Biological: Albumin Albumin 20g/l Drug: Diuretics Diuretics will be continued with an maximum dose of furosemide (160mg) and Aldactone 400 mg.

Arm

Intervention/Treatment

Experimental: 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.

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.

Active Comparator: Albumin with diuretics

Albumin(20g/l) and diuretics.

Biological: Albumin

Albumin 20g/l

Drug: Diuretics

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

Outcome Measures

Primary Outcome Measures

Change in frequency of thoracentesis. [3 months]

Secondary Outcome Measures

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 Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Institute of Liver and Biliary Sciences	New Delhi	Delhi	India	110070

Sponsors and Collaborators

Institute of Liver and Biliary Sciences, India

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Institute of Liver and Biliary Sciences, India

ClinicalTrials.gov Identifier:

NCT03645642

Other Study ID Numbers:

ILBS-Cirrhosis-18

First Posted:

Aug 24, 2018

Last Update Posted:

Jun 25, 2020

Last Verified:

Nov 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Hydrothorax

Midodrine

Diuretics

Study Results

No Results Posted as of Jun 25, 2020