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

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.

Study Overview

• Status: Completed
• Conditions: Hepatic Hydrothorax
• Intervention / Treatment: Drug: Midodrine; Biological: Albumin; Drug: Diuretics

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Delhi
    • New Delhi, Delhi, India, 110070
      • Institute of Liver and Biliary Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 71 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in frequency of thoracentesis.	3 months

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Institute of Liver and Biliary Sciences, India

Study record dates

Study Major Dates

• Study Start (Actual): September 30, 2018
• Primary Completion (Actual): December 31, 2018
• Study Completion (Actual): December 31, 2018

Study Registration Dates

• First Submitted: August 22, 2018
• First Submitted That Met QC Criteria: August 23, 2018
• First Posted (Actual): August 24, 2018

Study Record Updates

• Last Update Posted (Actual): June 25, 2020
• Last Update Submitted That Met QC Criteria: June 23, 2020
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Pleural Diseases; Hydrothorax; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Adrenergic alpha-Agonists; Adrenergic Agonists; Natriuretic Agents; Sympathomimetics; Vasoconstrictor Agents; Adrenergic alpha-1 Receptor Agonists; Diuretics; Midodrine
• Other Study ID Numbers: ILBS-Cirrhosis-18

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No