Decompensated CirrhosisNCT04208776
Efficacy of Combination of Midodrine With Propranolol in Preventing First Bleed in Decompensated Cirrhotics With Severe Ascites.
A study testing Propranolol and Midodrine in people with Decompensated Cirrhosis and Severe Ascites, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
Trial summary
Study population: Decompensated cirrhotics requiring primary prophylaxis with asciteswho are admitted to and attending the OPD at ILBS. Study Design : A Randomized controlled trial Study period : August 2019 to December 2020 (1.5 Years) Intervention : Treatment naïve patients will be given Propranolol and dose will be… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Decompensated Cirrhosis, Severe Ascites
- What is being tested?
- Propranolol and Midodrine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteIndia
- Study dates
- 4 Feb 2020to 31 Dec 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Decompensated Child C cirrhotics with grade II-III requiring primary prophylaxis
Who cannot join
- Spontaneous bacterial peritonitis
- Hepatic Encephalopathy
- Acute renal failure (S.Cr>1.5)
- Hepatorenal syndrome
- Hypertension
- Coronary Artery Disease ; H/o arrhythmias, heart block
Show all 12Show fewer
- Urinary retention
- Pheochromocytoma/thyrotoxicosis
- Coronary Obstructive Pulmonary Disease
- Hepatocellular Carcinoma
- Pregnancy
- Portal vein Thrombosis
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: Efficacy of Combination of Midodrine With Propranolol in Preventing First Bleed in Decompensated Cirrhotics With Severe Ascites: A Randomized Controlled Trial"
Study population: Decompensated cirrhotics requiring primary prophylaxis with asciteswho are admitted to and attending the OPD at ILBS.
Study Design : A Randomized controlled trial Study period : August 2019 to December 2020 (1.5 Years) Intervention : Treatment naïve patients will be given Propranolol and dose will be titrated every 2ndday to attain a target heart rate of 55.
Read more
One group patients will be given maximum tolerated dose of propranolol with initial dosage of 20mg once a day and uptitrating every 2nd day by 20 mg.The patients who bleed will undergo EVL session.
To the other group Midodine will be added to Propranolol.It will be started at 2.5mg TDS and will be uptitrated every 2nd day to a max of 10mg TDS to attain a MAP of atleast 70mm Hg and then uptitate the beta blocker simulataneously to attain the target heart rate. The patients who bleed will undergo EVL session.
Monitoring and assessment :
The patient will be monitored every day. The patient will undergo physical examination, complete blood counts, at baseline, LFT, KFT, at every 2nd day and day 7 from the start of therapy.
Adverse effects : Bradycardia and hypotension due to beta blockers Stopping rule : Severe hyponatraemia (<125), low mean arterial pressure(<65) or cardiac output and increasing serum creatinine(>1.5) identifies more vulnerable patients among those with decompensated cirrhosis, in whom a dose reduction or temporal discontinuation of NSBB treatment will be considered.
- Conditions
- Decompensated Cirrhosis, Severe Ascites
- Being tested
- Propranolol, Midodrine
- Medical subject headings
- Ascites
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropranololDrug
maximum tolerated dose of propranolol with initial dosage of 20mg once a day and uptitrating every 2nd day by 20 mg.
MidodrineDrug
It will be started at 2.5mg TDS and will be uptitrated every 2nd day to a max of 10mg TDS to attain a MAP of atleast 70mm Hg and then uptitate the beta blocker simulataneously to attain the target heart rate
| Study group | Role | What they receive |
|---|---|---|
| Midodrine+Propranolol | Experimental | Not described Receives: Drug: Propranolol; Drug: Midodrine |
| Propranolol | Active comparator | Not described Receives: Drug: Propranolol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary prevention of first variceal bleed in both groups
prevention of first variceal bleed is based on clinicallly
Measured: 1 year
Secondary outcomes (17)
Achievement of target heart rate (THR) of 55-60 or reduction by 25 % from baseline
Measured: Day 7
HVPG reduction in both groups
HVPG reduction by 20% from baseline
Measured: Day 90
Survival in both groups
Measured: 1 year
Incidence of therapeutic paracentesis in both groups
Measured: Day 30
Incidence of therapeutic paracentesis in both groups
Measured: Day 90
Incidence of decrease in ascites by at least one grade in both groups
Measured: 3 months
Paracentesis induced circulatory dysfunction(PICD) in both groups
PICD is defined as Incidence of AKI and HE after paracentesis
Measured: 1 year
Incidence of Hyponatremia in both groups
cut off for Hyponatremia is Sodium < 135
Measured: 1 year
Episodes of bacterial infection in both groups
Bacterial infection will be identified by culture tests
Measured: 1 year
Incidence of Hepatic Encephalopathy in both groups
Measured: 1 year
Incidence of Hepato Renal Syndrome in both groups
Measured: 1 year
Incidence of Acute Kidney Injury in both groups
Measured: 1 year
Incidence of Variceal bleed in both groups
Measured: 1 year
Number of TIPS (TransIntrahepatic Portosystemic Shunt) procedure done in both groups
Measured: 1 year
Number of patients who will receive diuretics in both groups
Measured: 1 year
Adverse effects of drugs in both groups
Measured: 1 year
Impact on portal, systemic and cardiac hemodynamics in both groups
For Portal and cardiac HVPG and right heart pressure studies will be done and for systemic blood pressure will be measured
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2019
- Study start4 Feb 2020
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Decompensated CirrhosisStudies 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
- 140 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
- NCT04208776
- Sponsor's protocol ID
- ILBS-Cirrhosis-27
- Status last verified
- Mar 2024
- First submitted
- 12 Dec 2019
- Last updated
- 20 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Combination of Midodrine With Propranolol in Preventing First Bleed in Decompensated Cirrhotics With Severe Ascites: A Randomized Controlled Trial"
- ClinicalTrials.gov ID
- NCT04208776
- Acronym / sponsor ID
- ILBS-Cirrhosis-27
- Conditions
- Decompensated Cirrhosis, Severe Ascites
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Institute of Liver and Biliary Sciences, IndiaUniversity, hospital or other
- Study start
- 4 Feb 2020 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 23 Dec 2019 (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.
Study population: Decompensated cirrhotics requiring primary prophylaxis with asciteswho are admitted to and attending the OPD at ILBS.
Study Design : A Randomized controlled trial Study period : August 2019 to December 2020 (1.5 Years) Intervention : Treatment naïve patients will be given Propranolol and dose will be titrated every 2ndday to attain a target heart rate of 55.
One group patients will be given maximum tolerated dose of propranolol with initial dosage of 20mg once a day and uptitrating every 2nd day by 20 mg.The patients who bleed will undergo EVL session.
To the other group Midodine will be added to Propranolol.It will be started at 2.5mg TDS and will be uptitrated every 2nd day to a max of 10mg TDS to attain a MAP of atleast 70mm Hg and then uptitate the beta blocker simulataneously to attain the target heart rate. The patients who bleed will undergo EVL session.
Monitoring and assessment :
The patient will be monitored every day. The patient will undergo physical examination, complete blood counts, at baseline, LFT, KFT, at every 2nd day and day 7 from the start of therapy.
Adverse effects : Bradycardia and hypotension due to beta blockers Stopping rule : Severe hyponatraemia (<125), low mean arterial pressure(<65) or cardiac output and increasing serum creatinine(>1.5) identifies more vulnerable patients among those with decompensated cirrhosis, in whom a dose reduction or temporal discontinuation of NSBB treatment will be considered.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Midodrine+Propranolol | Experimental | Drug: Propranolol, Drug: Midodrine |
| Propranolol | Active comparator | Drug: Propranolol |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Decompensated Child C cirrhotics with grade II-III requiring primary prophylaxis
Key exclusion criteria (12 listed)
- Spontaneous bacterial peritonitis
- Hepatic Encephalopathy
- Acute renal failure (S.Cr>1.5)
- Hepatorenal syndrome
- Hypertension
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 |
|---|---|---|
| Propranololmaximum tolerated dose of propranolol with initial dosage of 20mg once a day and uptitrating every 2nd day by 20 mg. | Drug | Midodrine+Propranolol, Propranolol |
| MidodrineIt will be started at 2.5mg TDS and will be uptitrated every 2nd day to a max of 10mg TDS to attain a MAP of atleast 70mm Hg and then uptitate the beta blocker simulataneously to attain the target heart rate | Drug | Midodrine+Propranolol |
Primary outcome
Primary prevention of first variceal bleed in both groups
Time frame: 1 year
prevention of first variceal bleed is based on clinicallly
17 secondary outcomes
Achievement of target heart rate (THR) of 55-60 or reduction by 25 % from baseline
Time frame: Day 7
HVPG reduction in both groups
Time frame: Day 90
Survival in both groups
Time frame: 1 year
Incidence of therapeutic paracentesis in both groups
Time frame: Day 30
Incidence of therapeutic paracentesis in both groups
Time frame: Day 90
Incidence of decrease in ascites by at least one grade in both groups
Time frame: 3 months
Paracentesis induced circulatory dysfunction(PICD) in both groups
Time frame: 1 year
Incidence of Hyponatremia in both groups
Time frame: 1 year
Episodes of bacterial infection in both groups
Time frame: 1 year
Incidence of Hepatic Encephalopathy in both groups
Time frame: 1 year
Incidence of Hepato Renal Syndrome in both groups
Time frame: 1 year
Incidence of Acute Kidney Injury in both groups
Time frame: 1 year
Incidence of Variceal bleed in both groups
Time frame: 1 year
Number of TIPS (TransIntrahepatic Portosystemic Shunt) procedure done in both groups
Time frame: 1 year
Number of patients who will receive diuretics in both groups
Time frame: 1 year
Adverse effects of drugs in both groups
Time frame: 1 year
Impact on portal, systemic and cardiac hemodynamics in both groups
Time frame: 1 year
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 20 Mar 2024.
- Individual participant dataSharing planned: No
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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 Propranolol and Midodrine in people with Decompensated Cirrhosis and Severe Ascites, 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 1 inclusion and 12 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 20 Mar 2024. 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?
Primary prevention of first variceal bleed in both groups (time frame: 1 year). 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 20 Mar 2024.