Hepatic HydrothoraxNCT03645642
To Study the Safety and Efficacy of Midodrine With Albumin Versus Albumin Alone in Hepatic Hydrothorax
A study testing Midodrine, Albumin and Diuretics in people with Hepatic Hydrothorax, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
Trial 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.. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hepatic Hydrothorax
- What is being tested?
- Midodrine, Albumin and Diuretics
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteIndia
- Study dates
- 30 Sep 2018to 31 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with hepatic hydrothorax
- Patients with age from 18-75 years
- No evidence of Cardiac and pulmonary disease
Who cannot join
- 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)
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
India1 site
Institute of Liver and Biliary Sciences
New Delhi, National Capital Territory of Delhi, 110070
About this study
Official title: 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.
- Conditions
- Hepatic Hydrothorax
- Being tested
- Midodrine, Albumin, Diuretics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MidodrineDrug
Midodrine 5 mg thrice daily
AlbuminBiological
Albumin 20g/l
DiureticsDrug
Diuretics will be continued with an maximum dose of furosemide (160mg) and Aldactone 400 mg.
| Study group | Role | What they receive |
|---|---|---|
| Midodrine | Experimental | 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. Receives: Drug: Midodrine; Biological: Albumin; Drug: Diuretics |
| Albumin with diuretics | Active comparator | Albumin(20g/l) and diuretics. Receives: Biological: Albumin; Drug: Diuretics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in frequency of thoracentesis.
Measured: 3 months
Secondary outcomes (7)
Partial or complete resolution of hepatic hydrothorax
Measured: 3 months
Development of Spontaneous Bacterial Empyema
Measured: 3 Months
Development of Thorocacocentesis Induced circulatory dysfunction
Measured: 3 Months
Drug related adverse events in both arms
Measured: 3 Months
Transplant free survival in both groups
Measured: 3 Months
Predictors and mechanisms of repeated development of hepatic hydrothorax
Measured: 3 Months
Number of patients going for TIPS(Transintrahepatic Portosystemic Shunts)
Measured: 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2018
- Study start30 Sep 2018
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic HydrothoraxStudies of the same condition, open and under way.
- More trials run by Institute of Liver and Biliary Sciences, IndiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Liver and Biliary Sciences, India
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03645642
- Sponsor's protocol ID
- ILBS-Cirrhosis-18
- Status last verified
- Nov 2019
- First submitted
- 22 Aug 2018
- Last updated
- 25 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Study the Safety and Efficacy of Midodrine With Albumin Versus Albumin Alone in Hepatic Hydrothorax- A Pilot Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT03645642
- Acronym / sponsor ID
- ILBS-Cirrhosis-18
- Conditions
- Hepatic Hydrothorax
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Institute of Liver and Biliary Sciences, IndiaUniversity, hospital or other
- Study start
- 30 Sep 2018 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 24 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Midodrine | Experimental | Drug: Midodrine, Biological: Albumin, Drug: DiureticsMidodrine (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 with diuretics | Active comparator | Biological: Albumin, Drug: DiureticsAlbumin(20g/l) and diuretics. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with hepatic hydrothorax
- Patients with age from 18-75 years
- No evidence of Cardiac and pulmonary disease
Key exclusion criteria (13 listed)
- Renal failure ( Creatinine>2.5mg/dl)
- Gastrointestinal bleeding
- Spontaneous bacterial empyema/ Peritonitis
- Patients with urinary retention
- Intrinsic advanced pulmonary disease (CXR, HRCT thorax)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MidodrineMidodrine 5 mg thrice daily | Drug | Midodrine |
| AlbuminAlbumin 20g/l | Biological | Albumin with diuretics, Midodrine |
| DiureticsDiuretics will be continued with an maximum dose of furosemide (160mg) and Aldactone 400 mg. | Drug | Albumin with diuretics, Midodrine |
Primary outcome
Change in frequency of thoracentesis.
Time frame: 3 months
7 secondary outcomes
Partial or complete resolution of hepatic hydrothorax
Time frame: 3 months
Development of Spontaneous Bacterial Empyema
Time frame: 3 Months
Development of Thorocacocentesis Induced circulatory dysfunction
Time frame: 3 Months
Drug related adverse events in both arms
Time frame: 3 Months
Transplant free survival in both groups
Time frame: 3 Months
Predictors and mechanisms of repeated development of hepatic hydrothorax
Time frame: 3 Months
Number of patients going for TIPS(Transintrahepatic Portosystemic Shunts)
Time frame: 3 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2020.
- Individual participant dataSharing planned: Undecided
Related trials for Hepatic Hydrothorax
Active, not recruiting
The BD Liverty™ TIPS Stent Graft Study
Portal Hypertension, TIPS
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Midodrine, Albumin and Diuretics in people with Hepatic Hydrothorax, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in frequency of thoracentesis. (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2020.