Evaluation of Albumin and Midodrine Versus Albumin Alone in Outcome of Refractory Ascites in Patients With Decompensated Cirrhosis.
NCT ID: NCT04816240
Last Updated: 2021-06-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
200 participants
INTERVENTIONAL
2021-05-15
2022-03-19
Brief Summary
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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.
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Detailed Description
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* 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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Midodrine + Albumin +Standard Medical Treatment
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).
Midodrine
5mg thrice daily and will be increased every 3 days upto 15 mg thrice daily with target MAP (\>75 mm and \<90)
Albumin
80grams/week for 2 weeks followed by 40gram/week
Standard Medical Treatment
Standard Medical Treatment
Albumin + Standard Medical Treatment+ Placebo
80grams/week for 2 weeks followed by 40gram/week + Placebo
Albumin
80grams/week for 2 weeks followed by 40gram/week
Standard Medical Treatment
Standard Medical Treatment
Placebo
Placebo
Interventions
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Midodrine
5mg thrice daily and will be increased every 3 days upto 15 mg thrice daily with target MAP (\>75 mm and \<90)
Albumin
80grams/week for 2 weeks followed by 40gram/week
Standard Medical Treatment
Standard Medical Treatment
Placebo
Placebo
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
* 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
18 Years
70 Years
ALL
No
Sponsors
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Institute of Liver and Biliary Sciences, India
OTHER
Responsible Party
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Locations
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Institute of Liver & Biliary Sciences
New Delhi, National Capital Territory of Delhi, India
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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ILBS-Cirrhosis-40
Identifier Type: -
Identifier Source: org_study_id
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