Liver CirrhosisNCT04816240
Evaluation of Albumin and Midodrine Versus Albumin Alone in Outcome of Refractory Ascites in Patients With Decompensated Cirrhosis.
A study testing Midodrine, Albumin and Standard Medical Treatment in people with Liver Cirrhosis, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
Trial summary
The project is about evaluation of albumin and midodrine versus albumin alone in outcome of refractory ascites in patients with decompensated cirrhosis. Cirrhosis is a leading cause of disability and mortality worldwide. Cirrhosis occurs in 50% of patients over 10 years. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Liver Cirrhosis
- What is being tested?
- Midodrine, Albumin and Standard Medical Treatment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteIndia
- Study dates
- 15 May 2021to 19 Mar 2022
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cirrhosis with refractory ascites
Who cannot join
- Recent Gastrointestinal bleeding within 7 days
- Systemic arterial hypertension (>160/90mmhg)
- Presence of hepatocellular carcinoma or portal vein thrombosis, Budd-chiari syndrome.
- Pregnancy
- No use of drugs affecting systemic hemodynamics 7 days prior to enrolment
- Patients with Cardiovascular disease (NYHA > II) or chronic obstructive pulmonary disease
Show all 15Show fewer
- Refusal to participate
- Known or suspected hypersensitivity to albumin
- Prior TIPS
- Post liver or kidney transplantation
- Patients enrolled in other clinical trials
- Extrahepatic malignancy
- Patients on cardiac glycosides like digoxin, phenylephrine, ephedrine, thyroid hormones, ergot derivatives, salt retaining steroids like fludrocortisone, MAO inhibitors, alpha blockers metformin and ranitidine (known to have interactions with midodrine)
- Patients with intrinsic kidney disease, organ nephropathy and CKD stage 4 and
- MELD > 30 and extremely moribend patient
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Institute of Liver & Biliary Sciences
New Delhi, National Capital Territory of Delhi, 110070
Dr Priti Gupta, MD, 01146300000, priti7vns@gmail.com
About this study
Official title: Evaluation of Albumin and Midodrine Versus Albumin Alone in Outcome of Refractory Ascites in Patients With Decompensated Cirrhosis - A Double Blind Randomized Controlled Trial."
The project is about evaluation of albumin and midodrine versus albumin alone in outcome of refractory ascites in patients with decompensated cirrhosis.
Cirrhosis is a leading cause of disability and mortality worldwide. Cirrhosis occurs in 50% of patients over 10 years. Decompensated cirrhosis carries a poor prognosis because the median survival time is about 2 years and it imposes a heavy burden on health care costs mainly due to the need for repeated hospital admission. The mortality is approximately 40% at 1 year and 50% at 2 years (12.7 per 100,000 population). A lot of times the prognosis is poor and the main factors leading to it are - AKI/HRS-NAKI, Hyponatremia, Grade of ascites-Refractory ascites, Sarcopenia, low Mean arterial pressure.
Read more
Post review of the literature, it is realized that there are some gap areas -
- It is unknown whether combination of vasoconstrictor with albumin further decreases the need for paracentesis in patients of refractory ascites.
- There are no studies till date on using combination of vasoconstrictor with albumin for refractory ascites.
- There are no studies evaluating the prevalence and incidence of HRS-NAKI using the new definitions in patients with refractory ascites and impact of combining vasoconstrictor and albumin in improving renal outcomes in these patients.
Read the detailed description
Study population All patients with decompensated cirrhosis with refractory ascites who get admitted under the Department of Hepatology at Institute of Liver and Biliary Sciences, who fulfilthe inclusion criteria, exclusion criteria and provide informed consent
- Study design Single Centre Placebo Controlled an open level Randomised Controlled Trial
- Study period 1 year from ethics approval.
- Sample size Assuming that survival rate with albumin and midodrine is 80%, whereas with albumin alone is 60% ( ie. 20% absolute difference is observed with alpha of 5% power so we need to enroll 170 cases allotted in 2 groups further taking 10% as dropout rate. It was decided to enroll 200 cases allotted in 2 groups randomly by block randomization method taking block size as 10
- Intervention Group A will be treated with SMT + Albumin + Midodrine (5mg thrice daily and will be increased every 3 days upto 15 mg thrice daily with target MAP (>75 mm and <90) and Group B with SMT + Albumin: 80grams/week for 2 weeks followed by 40gram/week + Placebo
Stopping ruleAdverse reaction to Albumin
- Cardiopulmonary compromise
- Allergic reaction
- Conditions
- Liver Cirrhosis
- Being tested
- Midodrine, Albumin, Standard Medical Treatment, Placebo
- Medical subject headings
- Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MidodrineDrug
5mg thrice daily and will be increased every 3 days upto 15 mg thrice daily with target MAP (>75 mm and <90)
AlbuminBiological
80grams/week for 2 weeks followed by 40gram/week
Standard Medical TreatmentOther
Standard Medical Treatment
PlaceboOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Midodrine + Albumin +Standard Medical Treatment | Experimental | SMT + Albumin + Midodrine (5mg thrice daily and will be increased every 3 days upto 15 mg thrice daily with target MAP (>75 mm and <90). Receives: Drug: Midodrine; Biological: Albumin; Other: Standard Medical Treatment |
| Albumin + Standard Medical Treatment+ Placebo | Active comparator | 80grams/week for 2 weeks followed by 40gram/week + Placebo Receives: Biological: Albumin; Other: Standard Medical Treatment; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival free of transplant and TIPS
Measured: 6 months
Secondary outcomes (16)
Cumulative incidence of liver-related complications
Measured: 3 months
Cumulative incidence of liver-related complications
Measured: 6 months
Cumulative incidence of liver-related complications
Measured: 12 months
Survival free of liver transplant in both groups
Measured: 1 year
Survival free of TIPS in both groups
Measured: 1 year
Incidence of HRS-AKD, in both groups at 1 year
Measured: 1 year
Incidence of HRS-CKD in both groups at 1 year
Measured: 1 year
Incidence of HRS AKI in both groups at 1 year
Measured: 1 year
Cumulative frequency of large volume paracentesis
Measured: 3 months
Cumulative frequency of large volume paracentesis
Measured: 6 months
Cumulative frequency of large volume paracentesis
Measured: 12 months
Improvement in fraility
AS PER MAYO FRAITITY INDEX , FRAITILY IS CLASSIFIED AS PRE FRAIL, FRAIL AND ROBUST.
Measured: 3 months
Improvement in fraility
AS PER MAYO FRAITITY INDEX , FRAITILY IS CLASSIFIED AS PRE FRAIL, FRAIL AND ROBUST.
Measured: 6 months
Improvement in fraility
AS PER MAYO FRAITITY INDEX , FRAITILY IS CLASSIFIED AS PRE FRAIL, FRAIL AND ROBUST.
Measured: 12 months
Survival free of TIPS
Measured: 6 months
Survival free of transplant at 6 months
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2021
- Study start15 May 2021
- Primary completion19 Mar 2022 (estimated)
- Study completion19 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 200 participants (estimated)
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
- NCT04816240
- Sponsor's protocol ID
- ILBS-Cirrhosis-40
- Status last verified
- Mar 2021
- First submitted
- 15 Mar 2021
- Last updated
- 15 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Albumin and Midodrine Versus Albumin Alone in Outcome of Refractory Ascites in Patients With Decompensated Cirrhosis - A Double Blind Randomized Controlled Trial."
- ClinicalTrials.gov ID
- NCT04816240
- Acronym / sponsor ID
- ILBS-Cirrhosis-40
- Conditions
- Liver Cirrhosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Institute of Liver and Biliary Sciences, IndiaUniversity, hospital or other
- Study start
- 15 May 2021 (actual)
- Primary completion
- 19 Mar 2022 (estimated)
- Study completion
- 19 Mar 2022 (estimated)
- First posted
- 25 Mar 2021 (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.
The project is about evaluation of albumin and midodrine versus albumin alone in outcome of refractory ascites in patients with decompensated cirrhosis.
Cirrhosis is a leading cause of disability and mortality worldwide. Cirrhosis occurs in 50% of patients over 10 years. Decompensated cirrhosis carries a poor prognosis because the median survival time is about 2 years and it imposes a heavy burden on health care costs mainly due to the need for repeated hospital admission. The mortality is approximately 40% at 1 year and 50% at 2 years (12.7 per 100,000 population). A lot of times the prognosis is poor and the main factors leading to it are - AKI/HRS-NAKI, Hyponatremia, Grade of ascites-Refractory ascites, Sarcopenia, low Mean arterial pressure.
Post review of the literature, it is realized that there are some gap areas -
- It is unknown whether combination of vasoconstrictor with albumin further decreases the need for paracentesis in patients of refractory ascites.
- There are no studies till date on using combination of vasoconstrictor with albumin for refractory ascites.
- There are no studies evaluating the prevalence and incidence of HRS-NAKI using the new definitions in patients with refractory ascites and impact of combining vasoconstrictor and albumin in improving renal outcomes in these patients.
Detailed description
Study population All patients with decompensated cirrhosis with refractory ascites who get admitted under the Department of Hepatology at Institute of Liver and Biliary Sciences, who fulfilthe inclusion criteria, exclusion criteria and provide informed consent
- Study design Single Centre Placebo Controlled an open level Randomised Controlled Trial
- Study period 1 year from ethics approval.
- Sample size Assuming that survival rate with albumin and midodrine is 80%, whereas with albumin alone is 60% ( ie. 20% absolute difference is observed with alpha of 5% power so we need to enroll 170 cases allotted in 2 groups further taking 10% as dropout rate. It was decided to enroll 200 cases allotted in 2 groups randomly by block randomization method taking block size as 10
- Intervention Group A will be treated with SMT + Albumin + Midodrine (5mg thrice daily and will be increased every 3 days upto 15 mg thrice daily with target MAP (>75 mm and <90) and Group B with SMT + Albumin: 80grams/week for 2 weeks followed by 40gram/week + Placebo
Stopping ruleAdverse reaction to Albumin
- Cardiopulmonary compromise
- Allergic reaction
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Midodrine + Albumin +Standard Medical Treatment | Experimental | Drug: Midodrine, Biological: Albumin, Other: Standard Medical TreatmentSMT + Albumin + Midodrine (5mg thrice daily and will be increased every 3 days upto 15 mg thrice daily with target MAP (>75 mm and <90). |
| Albumin + Standard Medical Treatment+ Placebo | Active comparator | Biological: Albumin, Other: Standard Medical Treatment, Other: Placebo80grams/week for 2 weeks followed by 40gram/week + Placebo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Cirrhosis with refractory ascites
Key exclusion criteria (15 listed)
- Recent Gastrointestinal bleeding within 7 days
- Systemic arterial hypertension (>160/90mmhg)
- Presence of hepatocellular carcinoma or portal vein thrombosis, Budd-chiari syndrome.
- Pregnancy
- No use of drugs affecting systemic hemodynamics 7 days prior to enrolment
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 |
|---|---|---|
| Midodrine5mg thrice daily and will be increased every 3 days upto 15 mg thrice daily with target MAP (>75 mm and <90) | Drug | Midodrine + Albumin +Standard Medical Treatment |
| Albumin80grams/week for 2 weeks followed by 40gram/week | Biological | Albumin + Standard Medical Treatment+ Placebo, Midodrine + Albumin +Standard Medical Treatment |
| Standard Medical TreatmentStandard Medical Treatment | Other | Albumin + Standard Medical Treatment+ Placebo, Midodrine + Albumin +Standard Medical Treatment |
| PlaceboPlacebo | Other | Albumin + Standard Medical Treatment+ Placebo |
Primary outcome
Survival free of transplant and TIPS
Time frame: 6 months
16 secondary outcomes
Cumulative incidence of liver-related complications
Time frame: 3 months
Cumulative incidence of liver-related complications
Time frame: 6 months
Cumulative incidence of liver-related complications
Time frame: 12 months
Survival free of liver transplant in both groups
Time frame: 1 year
Survival free of TIPS in both groups
Time frame: 1 year
Incidence of HRS-AKD, in both groups at 1 year
Time frame: 1 year
Incidence of HRS-CKD in both groups at 1 year
Time frame: 1 year
Incidence of HRS AKI in both groups at 1 year
Time frame: 1 year
Cumulative frequency of large volume paracentesis
Time frame: 3 months
Cumulative frequency of large volume paracentesis
Time frame: 6 months
Cumulative frequency of large volume paracentesis
Time frame: 12 months
Improvement in fraility
Time frame: 3 months
Improvement in fraility
Time frame: 6 months
Improvement in fraility
Time frame: 12 months
Survival free of TIPS
Time frame: 6 months
Survival free of transplant at 6 months
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2021.
Related trials for Liver Cirrhosis
RecruitingObservational study
Effectiveness and Clinical Outcomes of Long-term Bulevirtide Monotherapy in Patients With HDV-related Compensated Cirrhosis
Hepatitis D
Recruiting
Optimal Treatment Strategy for Spontaneous Bacterial Peritonitis
Spontaneous Bacterial Peritonitis, Paracentesis
RecruitingObservational study
The Value of Spleen Thickness and Spleen Diameter for Gastroesophageal Varices Diagnosis in Compensated Cirrhosis
Liver Cirrhosis, Gastroesophageal Varices
Recruiting
CirrhosisRx CDS System
Cirrhosis, Decision Support Systems, Clinical
RecruitingPhase 3
Trial to Evaluate ALN-CIDEB in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Metabolic Dysfunction-Associated Steatotic Liver Disease, MASLD
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.
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 Standard Medical Treatment in people with Liver Cirrhosis, 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 15 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: status not confirmed, as of the sponsor's last update on 15 Jun 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dr Priti Gupta, MD (01146300000, priti7vns@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival free of transplant and TIPS (time frame: 6 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 15 Jun 2021.