- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03645642
To Study the Safety and Efficacy of Midodrine With Albumin Versus Albumin Alone in Hepatic Hydrothorax
June 23, 2020 updated by: Institute of Liver and Biliary Sciences, India
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
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
8
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Delhi
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New Delhi, Delhi, India, 110070
- Institute of liver and Biliary Sciences
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 73 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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
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.
|
Midodrine 5 mg thrice daily
Albumin 20g/l
Diuretics will be continued with an maximum dose of furosemide (160mg) and Aldactone 400 mg.
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Active Comparator: Albumin with diuretics
Albumin(20g/l) and diuretics.
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Albumin 20g/l
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.
Time Frame: 3 months
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Partial or complete resolution of hepatic hydrothorax
Time Frame: 3 months
|
3 months
|
Development of Spontaneous Bacterial Empyema
Time Frame: 3 Months
|
3 Months
|
Development of Thorocacocentesis Induced circulatory dysfunction
Time Frame: 3 Months
|
3 Months
|
Drug related adverse events in both arms
Time Frame: 3 Months
|
3 Months
|
Transplant free survival in both groups
Time Frame: 3 Months
|
3 Months
|
Predictors and mechanisms of repeated development of hepatic hydrothorax
Time Frame: 3 Months
|
3 Months
|
Number of patients going for TIPS(Transintrahepatic Portosystemic Shunts)
Time Frame: 3 Months
|
3 Months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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-
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