HPE Human Albumin | Page 16

and severe HE , was also significantly lower in the albumin arm of the study . The ANSWER study therefore confirmed a survival advantage from longterm use of albumin . 35
A further prospective , non-randomized trial enrolled patients with cirrhosis and refractory ascites . 36 Patients received standard care or albumin ( 20g twice a week ) plus standard of care and were followed for 24 months . The cumulative 24-month mortality was significantly lower in those receiving albumin ( 41.6 % vs 65.5 %, p = 0.032 , albumin + standard care vs standard care alone ). In addition , the cumulative incidence of re-hospitalizations due to complications of cirrhosis , such as hepatic encephalopathy , accumulation of ascites and bacterial infections , was significantly lower in patients treated with albumin . The authors concluded that long-term albumin treatment improved survival and reduced the probability of emergent hospitalizations .
However , the midodrine albumin in cirrhotic patients awaiting liver transplantation ( MACHT ) study challenged these results . 37 This placebocontrolled clinical trial randomized a total of 196 patients to receive either 40g albumin every 15 days plus the α1-receptor agonist midodrine ( 15 – 30mg / day according to their pressor response ; n = 87 ) and 86 to receive SMT or standard of care and matching placebos for a planned follow up of 12 months . The primary endpoint of the study was the incidence of complications of cirrhosis ( e . g ., renal failure , hyponatremia etc ) with mortality as a secondary outcome . Despite a mild improvement in effective volemia , there were no differences in the primary outcome . However , it is important to note that a higher proportion of those receiving albumin received transplantation ( 68 % vs 55 %), the duration of albumin therapy was only 80 days and that the dosage ( 40g every 15 days ) was lower than in other trials .
An analysis of studies of the effect of albumin treatment on systemic and portal hemodynamics and systemic inflammation in those with decompensated cirrhosis concluded that albumin therapy reduced systemic inflammation and cardiocirculatory dysfunction . 38 A recent open label RCT of albumin to prevent infection in chronic liver failure ( ATTIRE ) enrolled 777 hospitalized patients with decompensated cirrhosis , acute complications , and a serum albumin level below 30g / l . 39 The intervention arm involved giving 20 % albumin infusion for 14 days or until discharge , whichever was observed first , and patients in the other arm were given standard medical care . The primary end point ( composite event of new infection , kidney dysfunction , or death between days 3 and 15 ) was similar in the two arms : 29.7 % ( 113 of 380 ) vs . 30.2 % ( 120 of 397 ) patients ( adjusted OR 0.98 ; 95 % CI , 0.71 – 1.33 , p = 0.87 ). Time to primary endpoint was also similar between the two arms . Further , a median of 200g albumin in the intervention arm and 20g in the other arm was administered , and serious adverse events were more frequent in the albumin intervention arm . 39 The authors concluded that albumin infusions in decompensated cirrhosis aiming to increase serum albumin levels above 30g / l did not provide any benefit over current standard of care .
Conclusion The available evidence would suggest that longterm albumin therapy is a promising treatment for patients with decompensated cirrhosis and that it not only controls ascites but also seems to positively influence the course of the disease .
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