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.