High Dose Albumin in Refractory Ascites

NCT05867602 | Recruiting Phase 2 FDA Drug

• 1 other identifier: H-49043
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Advanced cirrhosis with complications is a serious problem imposing a heavy financial burden on health care system. Moreover, ascites is associated with increase in mortality rates among cirrhotic patients. Ascites pathogenesis is multifactorial including: portal hypertension; splanchnic and peripheral arterial vasodilation; and neurohumoral activation. Current management strategies include dietary sodium restriction and diuretic therapy, however, this strategy put patients at the risk of intravascular volume depletion, renal impairment, hepatic encephalopathy and hyponatremia. Moreover, around 10% of patients do not respond to this strategy (termed: diuretics resistant) with 50% of them die within 6 months. This sub-group is managed by frequent large volume paracentesis along with intravenous albumin administration and are usually considered for liver transplantation (LT) and TIPS. Nonetheless, Frequent paracentesis increases the risk of infection, bleeding, bowel perforation, paracentesis-induced circulatory dysfunction (PICD) and renal dysfunction in this sub-group of patients. The beneficial effect of human albumin might result from blood volume expansion tapering activated vasoconstrictor and sodium-retaining systems improving renal perfusion, hence regular infusion of albumin may be beneficial to prevent development of ascites and to improve survival. The positive effects of albumin are supported by previous studies; Romanelli et al, showed a significant increase in survival rate among cirrhotic patients with ascites when compared to those who did not receive albumin. Moreover, a randomized multicenter open label trial published in lancet last year, demonstrated that long term albumin administration improved 18-month survival, decreased the use of paracentesis and decrease in the incidence of cirrhosis related complications among cirrhotic patients with ascites. As of today, there's a limited use of regular high dose albumin in cirrhotic patients with ascites in US, despite being used elsewhere in the world as previously stated. The investigators wish to study long-term efficacy of human albumin administration in patients with decompensated cirrhosis to assess safety and efficacy, and prevention of complications of cirrhosis.

Conditions

Ascites

Keywords

refractory ascites; liver cirrhosis; HRS; High dose albumin

Outcome Measures

Primary Outcomes (2)

• Number of large volume paracentesis needed

  Number of paracentesis/thoracentesis needed.

  1 year

• The volume of fluid removed in liters per after high-dose albumin administration

  Measuring the fluid amount removed each paracentesis and compare it to before High dose albumin administration

  1 year

Secondary Outcomes (6)

• Incidence of cirrhosis related complications (spontaneous bacterial peritonitis, other bacterial infections, renal impairment, hepatorenal syndrome, hepatic encephalopathy and gastrointestinal bleeding related to portal hypertension).

  1 year

• Diuretics dosage assessment

  1 Year

• Liver related quality of life assessment.

  1 year

• Mortality at 1 year after enrollment

  1 year

• Number and duration of hospital admissions

  1 year

Study Arms (2)

Intervention arm

EXPERIMENTAL

the intervention group will receive intravenous human albumin at a dose of (1g/kg), with a minimum dose of 50g and a maximum dose of 100g, plus SOC

Drug: Albumin

Control arm

NO INTERVENTION

the control arm will receive the standard of care (SOC), including moderate sodium restriction, maximal daily tolerated doses of diuretics, and post-paracentesis albumin

Interventions

Albumin DRUG

intravenous human albumin at a dose of (1g/kg), with a minimum dose of 50g and a maximum dose of 100g

Also known as: High dose albumin (HA)

Intervention arm

Eligibility Criteria

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

You may qualify if:

• Age \> 18 years.
• patients diagnosed with liver cirrhosis.
• Refractory ascites which is defined as ascites failing to resolve after maximum tolerable dose of diuretics, and usually require frequent paracentesis.

You may not qualify if:

• Patients \< 18y
• patients with no history of liver cirrhosis
• patients with refractory ascites but have transjagular intrahepatic portosystemic shunts (TIPS) with previous 3 months
• Patients with ascites due to other causes, including cardiac, malignant

Sponsors & Collaborators

• Baylor College of Medicine: lead

Study Sites (1)

Baylor St' Lukes Medical center

Houston, Texas, 77030, United States

RECRUITING

Related Publications (7)

• Di Pascoli M, Ceranto E, De Nardi P, Donato D, Gatta A, Angeli P, Pontisso P. Hospitalizations Due to Cirrhosis: Clinical Aspects in a Large Cohort of Italian Patients and Cost Analysis Report. Dig Dis. 2017;35(5):433-438. doi: 10.1159/000458722. Epub 2017 Mar 1.

  PMID: 28245467 BACKGROUND

• Gines P, Quintero E, Arroyo V, Teres J, Bruguera M, Rimola A, Caballeria J, Rodes J, Rozman C. Compensated cirrhosis: natural history and prognostic factors. Hepatology. 1987 Jan-Feb;7(1):122-8. doi: 10.1002/hep.1840070124.

  PMID: 3804191 BACKGROUND

• Schmidt ML, Barritt AS, Orman ES, Hayashi PH. Decreasing mortality among patients hospitalized with cirrhosis in the United States from 2002 through 2010. Gastroenterology. 2015 May;148(5):967-977.e2. doi: 10.1053/j.gastro.2015.01.032. Epub 2015 Jan 23.

  PMID: 25623044 BACKGROUND

• Pedersen JS, Bendtsen F, Moller S. Management of cirrhotic ascites. Ther Adv Chronic Dis. 2015 May;6(3):124-37. doi: 10.1177/2040622315580069.

  PMID: 25954497 BACKGROUND

• Moore KP, Aithal GP. Guidelines on the management of ascites in cirrhosis. Gut. 2006 Oct;55 Suppl 6(Suppl 6):vi1-12. doi: 10.1136/gut.2006.099580. No abstract available.

  PMID: 16966752 BACKGROUND

• Pache I, Bilodeau M. Severe haemorrhage following abdominal paracentesis for ascites in patients with liver disease. Aliment Pharmacol Ther. 2005 Mar 1;21(5):525-9. doi: 10.1111/j.1365-2036.2005.02387.x.

  PMID: 15740535 BACKGROUND

• Romanelli RG, La Villa G, Barletta G, Vizzutti F, Lanini F, Arena U, Boddi V, Tarquini R, Pantaleo P, Gentilini P, Laffi G. Long-term albumin infusion improves survival in patients with cirrhosis and ascites: an unblinded randomized trial. World J Gastroenterol. 2006 Mar 7;12(9):1403-7. doi: 10.3748/wjg.v12.i9.1403.

  PMID: 16552809 BACKGROUND

MeSH Terms

Conditions

Ascites; Liver Cirrhosis

Interventions

Albumins

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• Prasun Jalal, MD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Prasun Jalal, MD

CONTACT

8323551424; jalal@bcm.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 20, 2023
• First Posted: May 22, 2023
• Study Start: March 25, 2019
• Primary Completion: March 25, 2026
• Study Completion (Estimated): June 25, 2026
• Last Updated: September 29, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)