High-dose albumin for fluid buildup in advanced cirrhosis

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with liver cirrhosis and fluid build-up in the belly (ascites) that does not go away with diuretics.

Age

Over 18 years.

Sex

All sexes can join.

Disease stage

Liver cirrhosis with refractory ascites: belly fluid that stays despite the highest tolerated dose of diuretics (water pills), usually needing frequent fluid drainage (paracentesis).

Earlier treatment

Must have had the maximum tolerable dose of diuretics without the fluid going away. People who had a TIPS (a shunt placed in the liver) in the previous 3 months cannot join.

Main reasons for not taking part

• Younger than 18 years
• No history of liver cirrhosis
• TIPS shunt placed within the previous 3 months
• Belly fluid from other causes, such as heart disease or cancer

The registry criteria, word for word

What the trial wants to find out

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 2 groups in the trial

• Intervention armTreatment being tested

  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

  Treatment: Albumin

• Control armNo study treatment, for comparison

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