Evaluation of Low-dose Albumin and Midodrine Versus Midodrine Alone in Outcome of Recurrent Ascites in Patients With Decompensated Cirrhosis.

NCT06245590 | Unknown

• 1 other identifier: ILBS-Cirrhosis-58
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

Brief 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). 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

Conditions

Decompensated Cirrhosis

Outcome Measures

Primary Outcomes (1)

• Survival free of transplant and TIPS at 6 months.

  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.

  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)

  6 & 12 months

Study Arms (2)

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).

Drug: Albumin; Drug: Midodrine

Midodrine +standard of care

ACTIVE COMPARATOR

Midodrine alone titrated based on MAP.

Drug: Midodrine; Other: Standard of Care

Interventions

Albumin DRUG

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).

Albumin + Midodrine

Midodrine DRUG

Midodrine

Albumin + Midodrine; Midodrine +standard of care

Standard of Care OTHER

Standard of Care

Midodrine +standard of care

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• yr and Cirrhosis with recurrent ascites.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Institute of Liver and Biliary Sciences, India: lead

Study Sites (2)

Asian Institute of Gastroenterology

Somājigūda, Hyderabad, 500082, India

Location

Institute of Liver & Biliary Sciences

New Delhi, National Capital Territory of Delhi, 110070, India

Location

MeSH Terms

Interventions

Albumins; Midodrine; Standard of Care

Intervention Hierarchy (Ancestors)

Proteins; Amino Acids, Peptides, and Proteins; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Central Study Contacts

Dr Rakhi Maiwall, DM

CONTACT

01146300000; rakhi_2011@yahoo.co.in

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2024
• First Posted: February 7, 2024
• Study Start: February 10, 2024
• Primary Completion: January 31, 2025
• Study Completion: January 31, 2025
• Last Updated: February 7, 2024

Record last verified: 2023-06

Locations

IN (2)