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
About this trial
This is an interventional treatment trial for Hepatic Hydrothorax
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
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
NCT ID
NCT03645642
First Posted
August 22, 2018
Last Updated
June 23, 2020
Sponsor
Institute of Liver and Biliary Sciences, India
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
Learn more about this trial
To Study the Safety and Efficacy of Midodrine With Albumin Versus Albumin Alone in Hepatic Hydrothorax
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