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

Primary Purpose

Hepatic Hydrothorax

Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Midodrine
Albumin
Diuretics
Sponsored by
Institute of Liver and Biliary Sciences, India
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatic Hydrothorax

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Institute of Liver and Biliary Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Midodrine

Albumin with diuretics

Arm Description

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(20g/l) and diuretics.

Outcomes

Primary Outcome Measures

Change in frequency of thoracentesis.

Secondary Outcome Measures

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

Full Information

First Posted
August 22, 2018
Last Updated
June 23, 2020
Sponsor
Institute of Liver and Biliary Sciences, India
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1. Study Identification

Unique Protocol Identification Number
NCT03645642
Brief Title
To Study the Safety and Efficacy of Midodrine With Albumin Versus Albumin Alone in Hepatic Hydrothorax
Official Title
To Study the Safety and Efficacy of Midodrine With Albumin Versus Albumin Alone in Hepatic Hydrothorax- A Pilot Randomised Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
September 30, 2018 (Actual)
Primary Completion Date
December 31, 2018 (Actual)
Study Completion Date
December 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institute of Liver and Biliary Sciences, India

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatic Hydrothorax

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Midodrine
Arm Type
Experimental
Arm Description
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.
Arm Title
Albumin with diuretics
Arm Type
Active Comparator
Arm Description
Albumin(20g/l) and diuretics.
Intervention Type
Drug
Intervention Name(s)
Midodrine
Intervention Description
Midodrine 5 mg thrice daily
Intervention Type
Biological
Intervention Name(s)
Albumin
Intervention Description
Albumin 20g/l
Intervention Type
Drug
Intervention Name(s)
Diuretics
Intervention Description
Diuretics will be continued with an maximum dose of furosemide (160mg) and Aldactone 400 mg.
Primary Outcome Measure Information:
Title
Change in frequency of thoracentesis.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Partial or complete resolution of hepatic hydrothorax
Time Frame
3 months
Title
Development of Spontaneous Bacterial Empyema
Time Frame
3 Months
Title
Development of Thorocacocentesis Induced circulatory dysfunction
Time Frame
3 Months
Title
Drug related adverse events in both arms
Time Frame
3 Months
Title
Transplant free survival in both groups
Time Frame
3 Months
Title
Predictors and mechanisms of repeated development of hepatic hydrothorax
Time Frame
3 Months
Title
Number of patients going for TIPS(Transintrahepatic Portosystemic Shunts)
Time Frame
3 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Institute of Liver and Biliary Sciences
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110070
Country
India

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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