Long-term albumin administration in decompensated cirrhosis (ANSWER): an open-label randomised trial

Caraceni, Paolo; Riggio, Oliviero; Angeli, Paolo; Alessandria, Carlo; Neri, Sergio; Foschi, Francesco Giuseppe; Levantesi, Fabio; Airoldi, Aldo; Boccia, S.; Svegliati‐Baroni, Gianluca; Fagiuoli, Stefano; Romanelli, Roberto Giulio; Cozzolongo, Raffaele; Marco, V. Di; Sangiovanni, Vincenzo; Morisco, Filomena; Toniutto, Pierluigi; Tortora, Annalisa; Marco, Rosanna De; Angélico, M.; Cacciola, Irene; Elia, G.; Federico, Alessandro; Massironi, Sara; Guarisco, Riccardo; Galioto, Alessandra; Ballardini, G.; Rendina, Maria; Nardelli, Silvia; Piano, Salvatore; Elia, Chiara; Prestianni, Loredana; Cappa, Federica Mirici; Cesarini, Lucia; Simone, L.; Pasquale, Chiara; Cavallin, M.; Andrealli, Alida; Fidone, Federica; Ruggeri, Matteo; Roncadori, Andrea; Baldassarre, Maurizio; Tufoni, Manuel; Zaccherini, Giacomo; Bernardi, Mauro; Domenicali, Marco; Giannone, Ferdinando; Merli, Manuela; Gioia, Stefania; Fasolato, S.; Sticca, A.; Campion, Daniela; Risso, À.; Saracco, Giorgio Maria; Maiorca, D.; Rizzotto, Agostino; Lanzi, Arianna; Neri, Elga; Visani, Anna; Mastroianni, Antonio; Alberti, A.; Mazzarelli, Chiara; Vangeli, Marcello; Marzioni, Marco; Capretti, Francesca; Kostandini, Alba; Magini, Giulia; Colpani, M.; Laffi, Giacomo; Gabbani, Tommaso; Marsico, Maria De; Zappimbulso, M.; Petruzzi, Josè; Calvaruso, V.; Parrella, Giovanni; Caporaso, Nicola; Auriemma, Francesco; Guarino, Maria; Pugliese, Fabio; Gasbarrini, Antonio; Leo, Pietro; Leonardis, Francesco De; Pecchioli, A.; Rossi, Piera; Raimondo, Giovanni; Negri, Elisa; Dallio, Marcello; Loguercio, Carmelina; Conte, Dario; Celli, Natascia; Bringiotti, R.; Castellaneta, N.M.; Salerno, Francesco

doi:10.1016/s0140-6736(18)30840-7

Cited by 396 publications

(398 citation statements)

References 33 publications

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“…In one study, long‐term treatment with albumin has been shown to be effective in preventing recurrence of ascites in patients with cirrhosis, while in another cohort of patients admitted for first onset of ascites, the chronic administration of albumin reduced not only ascites recurrence but also mortality . These results were recently confirmed in a large multicentre randomized clinical trial, showing that in patients with cirrhosis and non‐refractory ascites, long‐term administration of human albumin at the same doses used in our present study ameliorates the control on ascites formation, reduces complications and improves survival . On the other hand, in patients with cirrhosis in the waiting list for liver transplantation, Solà et al did not confirm a positive effect of albumin in association with midodrine on complications development and mortality, but it is noteworthy that the dose of albumin administered was half compared to the one used in our study.…”

Section: Discussionsupporting

confidence: 71%

Long‐term administration of human albumin improves survival in patients with cirrhosis and refractory ascites

Pascoli

Fasolato

Piano

et al. 2018

Liver International

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101

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Section: Discussionsupporting

confidence: 71%

Long‐term administration of human albumin improves survival in patients with cirrhosis and refractory ascites

Pascoli

Fasolato

Piano

et al. 2018

Liver International

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101

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“…It is also imperative that every effort should be made to treat or slow the progression of CKD in patients with cirrhosis. Although not specifically addressed in this study, the literature has reported that the regular use of albumin in patients with ascites can significantly reduce the incidence of renal dysfunction (defined as SCr >1.5 mg/dL/1.73 m 2 ) and HRS1, most likely related to improved hemodynamics in patients with decompensated cirrhosis and ascites. Likewise, the management of NAFLD or NASH with lifestyle changes or medications could potentially prevent the development of or delay the progression of CKD in these patients, although lifestyle changes may be more difficult to achieve than regular use of albumin.…”

Section: Discussionmentioning

confidence: 96%

Impact of Chronic Kidney Disease on Outcomes in Cirrhosis

Wong

Reddy

O’Leary³

et al. 2019

Liver Transpl

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We hypothesize that the prevalence of chronic kidney disease (CKD) among patients with cirrhosis has increased due to the increased prevalence of CKD‐associated comorbidities, such as diabetes. We aimed to assess the characteristics of hospitalized patients with cirrhosis with CKD and its impact on renal and patient outcomes. The North American Consortium for the Study of End‐Stage Liver Disease (NACSELD) prospectively enrolled nonelectively admitted patients with cirrhosis and collected data on demographics, laboratory results, in‐hospital clinical course, and postdischarge 3‐month outcomes. CKD positive (CKD+) patients, defined as having an estimated glomerular filtration rate (eGFR; Modification of Diet in Renal Disease–4 variable formula) of ≤60 mL/minute for >3 months, were compared with chronic kidney disease negative (CKD–) patients for development of organ failures, hospital course, and survival. There were 1099 CKD+ patients (46.8% of 2346 enrolled patients) who had significantly higher serum creatinine (2.21 ± 1.33 versus 0.83 ± 0.21 mg/dL in the CKD– group) on admission, higher prevalence of nonalcoholic steatohepatitis cirrhosis etiology, diabetes, refractory ascites, and hospital admissions in the previous 6 months compared with the CKD– group (all P < 0.001). Propensity matching (n = 922 in each group) by Child‐Pugh scores (9.78 ± 2.05 versus 9.74 ± 2.04, P = 0.70) showed that CKD+ patients had significantly higher rates of superimposed acute kidney injury (AKI; 68% versus 21%; P < 0.001) and eventual need for dialysis (11% versus 2%; P < 0.001) than CKD– patients. CKD+ patients also had more cases of acute‐on‐chronic liver failure as defined by the NACSELD group, which was associated with reduced 30‐ and 90‐day overall survival (P < 0.001 for both). A 10 mL/minute drop in eGFR was associated with a 13.1% increase in the risk of 30‐day mortality. In conclusion, patients with CKD should be treated as a high‐risk group among hospitalized patients with cirrhosis due to their poor survival, and they should be monitored carefully for the development of superimposed AKI.

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“…Three studies assessing the effects of longterm albumin administration to patients with decompensated cirrhosis have been published in the current year. The ANSWER study, a multicenter, investigator‐initiated, open‐label, randomized trial enrolled 431 patients with cirrhosis and uncomplicated ascites requiring the daily administration of 200 mg of an antialdosteronic drug and 25 mg of furosemide . Patients were randomized to receive either standard medical treatment (SMT), which included albumin administration for well‐established indications, or SMT plus 40 g of albumin twice a week for the initial 2 weeks and then 40 g once a week.…”

Section: Available Evidence On the Effects Of Longterm Albumin Adminimentioning

confidence: 99%

Pro: The Role of Albumin in Pre–Liver Transplant Management

2019

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The wait‐list mortality of patients with decompensated cirrhosis awaiting liver transplantation remains elevated due to the occurrence of complications. Etiologic treatments improve patient survival and lower the incidence of complications when applied in compensated cirrhosis, but a decompensated disease does not improve or even progress despite a response to therapy in a substantial number of patients. Thus, disease‐modifying treatments that reduce the incidence of complications and improve survival are most needed. Such treatments should be able to counteract one or possibly more pathophysiological mechanisms and thus lead to the proinflammatory and pro‐oxidant milieu that characterizes decompensated cirrhosis. In this respect, albumin represents a potentially ideal agent. In fact, besides its ability to expand plasma volume, albumin possesses nononcotic properties, exerting potent antioxidant and immune‐modulating effects. Recent studies have assessed the effect of longterm albumin administration in decompensated cirrhosis. Although the results of these studies may appear conflicting, their analyses suggest that albumin, if given in a sufficient amount and for a sufficient duration, can significantly reduce the incidence of life‐threatening complications of cirrhosis and patient mortality. For these reasons, we favor albumin administration to patients with decompensated cirrhosis wait‐listed for liver transplantation.

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Long-term albumin administration in decompensated cirrhosis (ANSWER): an open-label randomised trial

Abstract: Italian Medicine Agency.

Cited by 396 publications

References 33 publications

Long‐term administration of human albumin improves survival in patients with cirrhosis and refractory ascites

Long‐term administration of human albumin improves survival in patients with cirrhosis and refractory ascites

Impact of Chronic Kidney Disease on Outcomes in Cirrhosis

Pro: The Role of Albumin in Pre–Liver Transplant Management

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