Evaluation of Albumin and Midodrine Versus Albumin Alone in Outcome of Refractory Ascites in Pati… (NCT04816240) | Clinical Trial Compass
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Evaluation of Albumin and Midodrine Versus Albumin Alone in Outcome of Refractory Ascites in Patients With Decompensated Cirrhosis.
India200 participantsStarted 2021-05-15
Plain-language 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. 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.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
\- Cirrhosis with refractory ascites
Exclusion Criteria:
\- 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
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Survival free of transplant and TIPS
Timeframe: 6 months
Trial details
NCT IDNCT04816240
SponsorInstitute of Liver and Biliary Sciences, India