Evaluation of Albumin and Midodrine Versus Albumin Alone in Outcome of Refractory Ascites in Patients With Decompensated Cirrhosis.

• Status: Recruiting
• Trial end date: 2022-03-19
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Institute of Liver and Biliary Sciences, India
• Treatments: Midodrine

Criteria

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