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

NCT04816240 | Unknown

• 1 other identifier: ILBS-Cirrhosis-40
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Liver Cirrhosis

Outcome Measures

Primary Outcomes (1)

• Survival free of transplant and TIPS

  6 months

Secondary Outcomes (16)

• Cumulative incidence of liver-related complications

  3 months

• Cumulative incidence of liver-related complications

  6 months

• Cumulative incidence of liver-related complications

  12 months

• Survival free of liver transplant in both groups

  1 year

• Survival free of TIPS in both groups

  1 year

Study Arms (2)

Midodrine + Albumin +Standard Medical Treatment

EXPERIMENTAL

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).

Drug: Midodrine; Biological: Albumin; Other: Standard Medical Treatment

Albumin + Standard Medical Treatment+ Placebo

ACTIVE COMPARATOR

80grams/week for 2 weeks followed by 40gram/week + Placebo

Biological: Albumin; Other: Standard Medical Treatment; Other: Placebo

Interventions

Midodrine DRUG

5mg thrice daily and will be increased every 3 days upto 15 mg thrice daily with target MAP (\>75 mm and \<90)

Midodrine + Albumin +Standard Medical Treatment

Albumin BIOLOGICAL

80grams/week for 2 weeks followed by 40gram/week

Albumin + Standard Medical Treatment+ Placebo; Midodrine + Albumin +Standard Medical Treatment

Standard Medical Treatment OTHER

Standard Medical Treatment

Albumin + Standard Medical Treatment+ Placebo; Midodrine + Albumin +Standard Medical Treatment

Placebo OTHER

Placebo

Albumin + Standard Medical Treatment+ Placebo

Eligibility Criteria

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

You may qualify if:

• \- Cirrhosis with refractory 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 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

Sponsors & Collaborators

• Institute of Liver and Biliary Sciences, India: lead

Study Sites (1)

Institute of Liver & Biliary Sciences

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

RECRUITING

MeSH Terms

Conditions

Liver Cirrhosis

Interventions

Midodrine; Albumins

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Proteins; Amino Acids, Peptides, and Proteins

Central Study Contacts

Dr Priti Gupta, MD

CONTACT

01146300000; priti7vns@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2021
• First Posted: March 25, 2021
• Study Start: May 15, 2021
• Primary Completion: March 19, 2022
• Study Completion: March 19, 2022
• Last Updated: June 15, 2021

Record last verified: 2021-03

Locations

IN (1)