High Dose Albumin for Ascites
Trial Summary
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, since the trial focuses on patients with refractory ascites who are already on maximum tolerable doses of diuretics, it seems likely that you may continue your current treatment.
What data supports the effectiveness of the drug for treating ascites?
Is high dose albumin generally safe for humans?
How does the drug albumin differ from other treatments for ascites?
Albumin is unique because it acts as a plasma expander, helping to restore blood volume and pressure, which can improve the body's response to diuretics and prevent complications after fluid removal. It is particularly effective in preventing circulatory dysfunction after large-volume paracentesis and in reducing the risk of kidney problems in patients with liver cirrhosis.1341112
What is the purpose of this trial?
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.
Research Team
Prasun Jalal, MD
Principal Investigator
Baylor College of Medicine
Eligibility Criteria
This trial is for adults over 18 with liver cirrhosis and refractory ascites, which means their body retains fluid despite maximum diuretic treatment and often needs excess fluid removed.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either high-dose albumin or standard care for up to one year
Follow-up
Participants are monitored for safety and effectiveness after treatment
Open-label extension (optional)
Participants may opt into continuation of treatment long-term
Treatment Details
Interventions
- Albumin
Albumin is already approved in United States, European Union, Japan for the following indications:
- Acute Liver Failure
- Adult Respiratory Distress Syndrome
- Burns
- Cardiopulmonary Bypass
- Hypoalbuminemia
- Hemodialysis
- Hypovolemia
- Ovarian Hyperstimulation Syndrome
- Hypoalbuminemia
- Hypovolemia
- Ascites
- Spontaneous Bacterial Peritonitis
- Hepatic Encephalopathy
- Hepatorenal Syndrome
- Hypoalbuminemia
- Hypovolemia
- Ascites
- Spontaneous Bacterial Peritonitis
Find a Clinic Near You
Who Is Running the Clinical Trial?
Baylor College of Medicine
Lead Sponsor