Decompensated CirrhosisNCT06245590
Evaluation of Low-dose Albumin and Midodrine Versus Midodrine Alone in Outcome of Recurrent Ascites in Patients With Decompensated Cirrhosis.
A study testing Albumin and Midodrine in people with Decompensated Cirrhosis, run by Institute of Liver and Biliary Sciences, India at 2 sites in India.
Trial summary
The project is about evaluation of albumin and midodrine versus midodrine alone in outcome of recurrent ascites in patients with decompensated cirrhosis. Cirrhosis occcurs in 50% of patients over 10 years. The mortality is approximately 40% at 1 year and 50% at 2 years (12.7 per 100,000 population). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Decompensated Cirrhosis
- What is being tested?
- Albumin and Midodrine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesIndia
- Study dates
- 10 Feb 2024to 31 Jan 2025
- 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
- 18 -70yr and Cirrhosis with recurrent 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 (excepting beta blockers) 7 days prior to enrolment.
- Patients with Cardiovascular disease (NYHA > II) or chronic obstructive pulmonary disease
Show all 18Show 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 > 25 and extremely moribund patient
- Serum albumin less than 2 gm/dl or >3.5 gm/dl
- Significant ongoing alcohol with abstinence less than 3 months
- Significant findings on ECHO with cardiac dysfunction
Trial locations and contacts
2 sites in 1 country.
India2 sites
Institute of Liver & Biliary Sciences
New Delhi, National Capital Territory of Delhi, 110070
Dr Rakhi Maiwall, DM, 01146300000, rakhi_2011@yahoo.co.in
Dr Rakhi Maiwall, DM
Asian Institute of Gastroenterology
Somājigūda, Hyderabad, 500082
Dr Mithun Sharma, DM, 04023378888, iecaig2044@gmail.com
About this study
Official title: Evaluation of Low-dose Albumin and Midodrine Versus Midodrine Alone in Outcome of Recurrent Ascites in Patients With Decompensated Cirrhosis - An Open Label Multicentric Randomized Controlled Trial.
The project is about evaluation of albumin and midodrine versus midodrine alone in outcome of recurrent ascites in patients with decompensated cirrhosis.
Cirrhosis occcurs in 50% of patients over 10 years. 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 - acute kidney injury, hepatorenal syndrome, hyponatremia, grade of ascites-recurrent 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 versus vasoconstrictor alone is superior for ascites resolution in patients with recurrent ascites.
- There are no studies till date on using combination of vasoconstrictor with albumin versus vasoconstrictor alone in patients with recurrent ascites.
- There are no studies on impact of combining vasoconstrictor and albumin in preventing the development of AKI and chronic kidney disease in these patients.
In an effort to bridge these gap areas, this project works on the following hypothesis - "Midodrine would have a synergistic effect with albumin in improving the systemic hemodynamics and circulatory dysfunction and will cause rapid control of ascites, reduce the incidence of large volume paracentesis (LVP), complications, reduce the incidence of chronic kidney disease (HRS-CKD) and improve outcome of patients with recurrent ascites in patients with decompensated cirrhosis as compared to midodrine alone"
Primary objective: To assess the effect of midodrine alone vs. a combination of midodrine and albumin on the survival free of TIPS and liver transplant at 6 months
Secondary objective:
The effect of midodrine alone vs. combination of midodrine and albumin on the cumulative frequency of therapeutic paracentesis at 6 and 12 months Proportion of patients achieving control of ascites at 6 and 12 months
Read the detailed description
- Study population: Consecutive patients with decompensated cirrhosis with recurrent ascites seen as inpatients or outpatients in the Department of Hepatology at Institute of Liver and Biliary Sciences, who meet the inclusion criteria and provide informed consent
- Study design: Multicentre Open-label Randomised Controlled Trial
- Sample Size: Assuming that survival rate with albumin and midodrine is 80%, whereas with midodrine alone is 50% (i.e. 30% absolute difference is observed with alpha of 5% power, beta of 80%) we need to enroll 43 cases in each arm and taking 15% drop out rate we need to enrol 50 cases in each group.
- Intervention: Group A will be treated with 20 grams/ week 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 midodrine alone titrated based on MAP. Albumin infusions will be provided with large volume paracentesis and if the patient develops AKI, SBP in the recommended dosage in accordance to the International Club of ascites. The protocol will be followed for 6 months
Adverse effects: Allergic reactions to albumin, worsening of dyspnea, volume-overload
Stopping Rule: adverse reaction to Albumin
- Cardiopulmonary compromise
- Allergic reaction
- Conditions
- Decompensated Cirrhosis
- Being tested
- Albumin, Midodrine, Standard of Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlbuminDrug
20 grams/ week Albumin + Midodrine (5mg thrice daily and will be increased every 3 days upto 15 mg thrice daily with target MAP (>75 mm and <90).
MidodrineDrug
Midodrine
Standard of CareOther
Standard of Care
| Study group | Role | What they receive |
|---|---|---|
| Albumin + Midodrine | Experimental | 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: Albumin; Drug: Midodrine |
| Midodrine +standard of care | Active comparator | Midodrine alone titrated based on MAP. Receives: Drug: Midodrine; Other: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival free of transplant and TIPS at 6 months.
Measured: 6 months
Secondary outcomes (2)
The cumulative mean of the number of therapeutic paracentesis at 6 and 12 months would be compared between the two groups.
Measured: 6 & 12 months
Proportion of patients achieving resolution of ascites (complete grade 1-0 without diuretics and partial as garde 0-1 ascites on diuretics)
Measured: 6 & 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2024
- Study start10 Feb 2024 (estimated)
- Primary completion31 Jan 2025 (estimated)
- Study completion31 Jan 2025 (estimated)
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
- 100 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
- NCT06245590
- Sponsor's protocol ID
- ILBS-Cirrhosis-58
- Status last verified
- Jun 2023
- First submitted
- 5 Jan 2024
- Last updated
- 7 Feb 2024
- 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 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Low-dose Albumin and Midodrine Versus Midodrine Alone in Outcome of Recurrent Ascites in Patients With Decompensated Cirrhosis - An Open Label Multicentric Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT06245590
- Acronym / sponsor ID
- ILBS-Cirrhosis-58
- Conditions
- Decompensated Cirrhosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Institute of Liver and Biliary Sciences, IndiaUniversity, hospital or other
- Study start
- 10 Feb 2024 (estimated)
- Primary completion
- 31 Jan 2025 (estimated)
- Study completion
- 31 Jan 2025 (estimated)
- First posted
- 7 Feb 2024 (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 midodrine alone in outcome of recurrent ascites in patients with decompensated cirrhosis.
Cirrhosis occcurs in 50% of patients over 10 years. 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 - acute kidney injury, hepatorenal syndrome, hyponatremia, grade of ascites-recurrent 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 versus vasoconstrictor alone is superior for ascites resolution in patients with recurrent ascites.
- There are no studies till date on using combination of vasoconstrictor with albumin versus vasoconstrictor alone in patients with recurrent ascites.
- There are no studies on impact of combining vasoconstrictor and albumin in preventing the development of AKI and chronic kidney disease in these patients.
In an effort to bridge these gap areas, this project works on the following hypothesis - "Midodrine would have a synergistic effect with albumin in improving the systemic hemodynamics and circulatory dysfunction and will cause rapid control of ascites, reduce the incidence of large volume paracentesis (LVP), complications, reduce the incidence of chronic kidney disease (HRS-CKD) and improve outcome of patients with recurrent ascites in patients with decompensated cirrhosis as compared to midodrine alone"
Primary objective: To assess the effect of midodrine alone vs. a combination of midodrine and albumin on the survival free of TIPS and liver transplant at 6 months
Secondary objective:
The effect of midodrine alone vs. combination of midodrine and albumin on the cumulative frequency of therapeutic paracentesis at 6 and 12 months Proportion of patients achieving control of ascites at 6 and 12 months
Detailed description
- Study population: Consecutive patients with decompensated cirrhosis with recurrent ascites seen as inpatients or outpatients in the Department of Hepatology at Institute of Liver and Biliary Sciences, who meet the inclusion criteria and provide informed consent
- Study design: Multicentre Open-label Randomised Controlled Trial
- Sample Size: Assuming that survival rate with albumin and midodrine is 80%, whereas with midodrine alone is 50% (i.e. 30% absolute difference is observed with alpha of 5% power, beta of 80%) we need to enroll 43 cases in each arm and taking 15% drop out rate we need to enrol 50 cases in each group.
- Intervention: Group A will be treated with 20 grams/ week 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 midodrine alone titrated based on MAP. Albumin infusions will be provided with large volume paracentesis and if the patient develops AKI, SBP in the recommended dosage in accordance to the International Club of ascites. The protocol will be followed for 6 months
Adverse effects: Allergic reactions to albumin, worsening of dyspnea, volume-overload
Stopping Rule: adverse reaction to Albumin
- Cardiopulmonary compromise
- Allergic reaction
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Albumin + Midodrine | Experimental | Drug: Albumin, Drug: MidodrineAlbumin + Midodrine (5mg thrice daily and will be increased every 3 days upto 15 mg thrice daily with target MAP (>75 mm and <90). |
| Midodrine +standard of care | Active comparator | Drug: Midodrine, Other: Standard of CareMidodrine alone titrated based on MAP. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 18 -70yr and Cirrhosis with recurrent ascites.
Key exclusion criteria (18 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 (excepting beta blockers) 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 |
|---|---|---|
| Albumin20 grams/ week Albumin + Midodrine (5mg thrice daily and will be increased every 3 days upto 15 mg thrice daily with target MAP (>75 mm and <90). | Drug | Albumin + Midodrine |
| MidodrineMidodrine | Drug | Albumin + Midodrine, Midodrine +standard of care |
| Standard of CareStandard of Care | Other | Midodrine +standard of care |
Primary outcome
Survival free of transplant and TIPS at 6 months.
Time frame: 6 months
2 secondary outcomes
The cumulative mean of the number of therapeutic paracentesis at 6 and 12 months would be compared between the two groups.
Time frame: 6 & 12 months
Proportion of patients achieving resolution of ascites (complete grade 1-0 without diuretics and partial as garde 0-1 ascites on diuretics)
Time frame: 6 & 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2024.
- Individual participant dataSharing planned: Undecided
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Albumin and Midodrine in people with Decompensated Cirrhosis, run by Institute of Liver and Biliary Sciences, India at 2 sites 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 18 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 7 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Rakhi Maiwall, DM (01146300000, rakhi_2011@yahoo.co.in), 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 at 6 months. (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 7 Feb 2024.