TABLE 1
Summary of studies of long-term albumin infusion 1
Study |
Design and follow up ( n ) |
Study population |
Length of infusion ( days ) |
Intervention |
Control |
|
Wilkinson and
Sherlock 21
|
Nonrandomised , single centre trial ; 22 months ; n = 16 |
Patients with cirrhosis and ascites , despite dietary and diuretic therapy |
616 Albumin 25 – 100g until serum colloid oncotic pressure 38 – 40cm of water |
Standard medical therapy ( SMT ) |
Gentilini et al 22
Single centre randomised , controlled trial ( RCT ); 3 years ; n = 126
Adult patients with cirrhosis 1095 Albumin 12.5g / day SMT
Romanelli et al 23
|
Single centre RCT ; 84 months ; n = 100 |
Adult patients with cirrhosis and new-onset clinically significant ascites |
1440 Albumin 25g / week in the first year , 25g every two weeks thereafter |
SMT |
Sola-Vera et al ( MACHT ) 24
|
Multicentre RCT ; 1 year ; n = 196 |
Patients with cirrhosis and ascites on liver transplant waiting list |
365 Midodrine 15 – 30mg / day and albumin 40g / 15 days for 1 year |
SMT |
Caraceni et al ( ANSWER trial ) 25
|
Multicentre RCT ; 18 months ; n = 431 |
Adult patients with medically controlled uncomplicated ascites |
540 Albumin 40g twice weekly for 2 weeks ; and 40g / week up to 18 months |
SMT |
Di Pascoli et al 26
|
Nonrandomised , prospective study ; mean 408 days ; n = 70 |
Adult patients with cirrhosis and refractory ascites |
720 |
Albumin 20g twice per week |
SMT and large-volume paracentesis if indicated |
|
China et al Multicentre ( ATTIRE ) 27 RCT ; 6 months ; n = 828 |
Adult patients with cirrhosis hospitalised with acute decompensation and hypoalbuminaemia ( serum albumin < 30g / l ) |
14 Albumin 20 – 80g / day until serum albumin levels ≥35g / l |
SMT |
Hepatorenal syndrome ( HRS ) HRS is the functional renal failure secondary to intra-renal vasoconstriction in patients with decompensated cirrhosis or acute liver failure . 12 The combination of albumin ( 20 – 40g / day ) and terlipressin infusion has been shown to reverse renal impairment in up to 56 % of patients with type-1 HRS ( also known as HRS-acute kidney injury ( HRS-AKI )). 12
Hepatic encephalopathy ( HE ) HE is a neuropsychiatric manifestation associated with poor prognosis in decompensated cirrhosis resulting from the complex interplay between effective circulatory volume , ammonia , systemic inflammation and portosystemic shunting . As albumin is known to improve systemic circulatory dysfunction and oxidative stress-mediated tissue injury , there has been growing interest in using albumin to treat or prevent HE . 16 A meta-analysis suggests albumin infusion might be useful for treatment and prevention of HE . 17 Dedicated studies are required to investigate the optional regimen and patient population that would best benefit from human albumin before it can be adopted into routine practice .
Acute-on-chronic liver failure ( ACLF ) ACLF is a distinct clinical entity characterised by systemic inflammation associated with multiorgan failure and high short-term mortality among decompensated cirrhosis patients . 18 A randomised trial showed that patients in the albumin group experienced resolution of ACLF ( 82.3 % vs 33.3 %) even though the overall mortality was similar to patients receiving antibiotics alone . 19 More data are also awaited from an ongoing randomised trial investigating the efficacy of albumin infusion in ACLF ( the ASIA trial ). 20
Long-term albumin infusion in decompensated cirrhosis Since Wilkinson and Sherlock first described the role of long-term albumin infusion in the 1960s , 21 there has been an increasing interest in its use in decompensated cirrhosis . Table 1 summarises the main studies that have been carried out .
12 | hospitalpharmacyeurope . com