Real-world experience with long-term albumin in patients with cirrhosis and ascites
Background & Aims: Long-term albumin (LTA) is currently standard of care for patients with decompensated cirrhosis in many Italian hepatology centres. In this real-life study, we aimed to describe patient, logistical and treatment-related characteristics in daily clinical practice and to ide...
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Elsevier
2024-12-01
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| author | Enrico Pompili Giacomo Zaccherini Salvatore Piano Pierluigi Toniutto Antonio Lombardo Stefania Gioia Giulia Iannone Clara De Venuto Marta Tonon Roberta Gagliardi Maurizio Baldassarre Greta Tedesco Giorgio Bedogni Marco Domenicali Vito Di Marco Silvia Nardelli Vincenza Calvaruso Davide Bitetto Paolo Angeli Paolo Caraceni |
| author_facet | Enrico Pompili Giacomo Zaccherini Salvatore Piano Pierluigi Toniutto Antonio Lombardo Stefania Gioia Giulia Iannone Clara De Venuto Marta Tonon Roberta Gagliardi Maurizio Baldassarre Greta Tedesco Giorgio Bedogni Marco Domenicali Vito Di Marco Silvia Nardelli Vincenza Calvaruso Davide Bitetto Paolo Angeli Paolo Caraceni |
| author_sort | Enrico Pompili |
| collection | DOAJ |
| description | Background & Aims: Long-term albumin (LTA) is currently standard of care for patients with decompensated cirrhosis in many Italian hepatology centres. In this real-life study, we aimed to describe patient, logistical and treatment-related characteristics in daily clinical practice and to identify predictors of response. Methods: We performed a multicentre, retrospective, observational study in patients with cirrhosis and ascites receiving LTA between 01/2016 and 02/2022 and followed until death, TIPS (transjugular intrahepatic portosystemic shunt) placement, transplantation or 02/2023. Results: A total of 312 patients, the majority with alcohol-related cirrhosis, were included. At baseline, median Child-Pugh, MELD, and MELD-Na were 8, 15, and 18, respectively. Ascites was grade 2 in 55% of patients, grade 3 in 35% and refractory in 27%, while 47% had received large volume paracentesis in the previous 6 months. Median LTA was 10 months with a median dose of 40 g/week. Ascites resolved to grade 0-1 in 34% of patients within the first 3 months and 56% by the end of treatment. Predictors of ascites resolution were age (p = 0.007), baseline grade of ascites (p = 0.007), no paracentesis in the previous 6 months (p = 0.001), aetiological treatment in the past 12 months or during LTA (p = 0.005), weekly albumin dose (p = 0.014) and serum albumin concentration of 40 g/L after 1 month of treatment (p = 0.017). Of the 83 patients with refractory ascites at inclusion, 26% had grade 0/1 ascites at the last observation. No severe albumin-related side-effects were reported and only 1% discontinued for logistical reasons. Conclusions: LTA is feasible as an outpatient treatment for the management of ascites. In the current study, ascites resolved in more than half of patients receiving LTA on top of diuretics, including in some with refractory ascites. Predictors of response to LTA provide useful information for tailoring treatment. Impact and implications:: The ANSWER randomised-controlled trial has shown that long-term albumin treatment (LTA) is an effective approach for the management of patients with cirrhosis and ascites. This observational study provides novel information on target patients, modalities and length of treatment, predictors of ascites resolution, stopping criteria, and clinical trajectories of patients on treatment. LTA is a feasible option in the daily clinical practice for the management of ascites when given on top of diuretics. Rather than an alternative therapy, LTA should be integrated with the other treatment options already available for patients with difficult-to-treat ascites. The predictive factors of response identified in the present study can help physicians to individualise LTA and optimise the decision-making process. |
| format | Article |
| id | doaj-art-e57b81c6ec67447e8975b9cc0021ff4a |
| institution | DOAJ |
| issn | 2589-5559 |
| language | English |
| publishDate | 2024-12-01 |
| publisher | Elsevier |
| record_format | Article |
| series | JHEP Reports |
| spelling | doaj-art-e57b81c6ec67447e8975b9cc0021ff4a2025-08-20T02:48:58ZengElsevierJHEP Reports2589-55592024-12-0161210122110.1016/j.jhepr.2024.101221Real-world experience with long-term albumin in patients with cirrhosis and ascitesEnrico Pompili0Giacomo Zaccherini1Salvatore Piano2Pierluigi Toniutto3Antonio Lombardo4Stefania Gioia5Giulia Iannone6Clara De Venuto7Marta Tonon8Roberta Gagliardi9Maurizio Baldassarre10Greta Tedesco11Giorgio Bedogni12Marco Domenicali13Vito Di Marco14Silvia Nardelli15Vincenza Calvaruso16Davide Bitetto17Paolo Angeli18Paolo Caraceni19Department of Medical and Surgical Sciences, Alma Mater Studiorum University of Bologna, Italy; Unit of Semeiotics, Liver and Alcohol-related diseases, IRCCS Azienda Ospedaliero-Universitaria di Bologna, ItalyDepartment of Medical and Surgical Sciences, Alma Mater Studiorum University of Bologna, Italy; Unit of Semeiotics, Liver and Alcohol-related diseases, IRCCS Azienda Ospedaliero-Universitaria di Bologna, ItalyUnit of Internal Medicine and Hepatology, Department of Medicine - DIMED, University and Hospital of Padova, ItalyHepatology and Liver Transplantation Unit, University Academic Hospital, Udine, ItalyUOC di Gastroenterologia, Dipartimento di Promozione della Salute, Materno Infantile, Medicina Interna e Specialistica (PROMISE), University of Palermo, ItalyDepartment of Translational and Precision Medicine, Sapienza University of Rome, ItalyDepartment of Medical and Surgical Sciences, Alma Mater Studiorum University of Bologna, Italy; Unit of Semeiotics, Liver and Alcohol-related diseases, IRCCS Azienda Ospedaliero-Universitaria di Bologna, ItalyDepartment of Medical and Surgical Sciences, Alma Mater Studiorum University of Bologna, Italy; Unit of Semeiotics, Liver and Alcohol-related diseases, IRCCS Azienda Ospedaliero-Universitaria di Bologna, ItalyUnit of Internal Medicine and Hepatology, Department of Medicine - DIMED, University and Hospital of Padova, ItalyUnit of Internal Medicine and Hepatology, Department of Medicine - DIMED, University and Hospital of Padova, ItalyUnit of Semeiotics, Liver and Alcohol-related diseases, IRCCS Azienda Ospedaliero-Universitaria di Bologna, ItalyDepartment of Medical and Surgical Sciences, Alma Mater Studiorum University of Bologna, ItalyDepartment of Medical and Surgical Sciences, Alma Mater Studiorum University of Bologna, Italy; Department of Primary Health Care, Internal Medicine Unit Addressed to Frailty and Aging, ''S. Maria Delle Croci'' Hospital, AUSL Romagna, Ravenna, ItalyDepartment of Medical and Surgical Sciences, Alma Mater Studiorum University of Bologna, Italy; Department of Primary Health Care, Internal Medicine Unit Addressed to Frailty and Aging, ''S. Maria Delle Croci'' Hospital, AUSL Romagna, Ravenna, ItalyUOC di Gastroenterologia, Dipartimento di Promozione della Salute, Materno Infantile, Medicina Interna e Specialistica (PROMISE), University of Palermo, ItalyDepartment of Translational and Precision Medicine, Sapienza University of Rome, ItalyUOC di Gastroenterologia, Dipartimento di Promozione della Salute, Materno Infantile, Medicina Interna e Specialistica (PROMISE), University of Palermo, ItalyHepatology and Liver Transplantation Unit, University Academic Hospital, Udine, ItalyUnit of Internal Medicine and Hepatology, Department of Medicine - DIMED, University and Hospital of Padova, ItalyDepartment of Medical and Surgical Sciences, Alma Mater Studiorum University of Bologna, Italy; Unit of Semeiotics, Liver and Alcohol-related diseases, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Italy; Corresponding author. Address: Department of Medical and Surgical Sciences, Alma Mater Studiorum University of Bologna, Unit of Semeiotics, Liver and Alcohol-related diseases, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Via Albertoni 15, 40138 Bologna, Italy; Tel.: +39 051 214 2919, fax: +39 051 214 2930.Background & Aims: Long-term albumin (LTA) is currently standard of care for patients with decompensated cirrhosis in many Italian hepatology centres. In this real-life study, we aimed to describe patient, logistical and treatment-related characteristics in daily clinical practice and to identify predictors of response. Methods: We performed a multicentre, retrospective, observational study in patients with cirrhosis and ascites receiving LTA between 01/2016 and 02/2022 and followed until death, TIPS (transjugular intrahepatic portosystemic shunt) placement, transplantation or 02/2023. Results: A total of 312 patients, the majority with alcohol-related cirrhosis, were included. At baseline, median Child-Pugh, MELD, and MELD-Na were 8, 15, and 18, respectively. Ascites was grade 2 in 55% of patients, grade 3 in 35% and refractory in 27%, while 47% had received large volume paracentesis in the previous 6 months. Median LTA was 10 months with a median dose of 40 g/week. Ascites resolved to grade 0-1 in 34% of patients within the first 3 months and 56% by the end of treatment. Predictors of ascites resolution were age (p = 0.007), baseline grade of ascites (p = 0.007), no paracentesis in the previous 6 months (p = 0.001), aetiological treatment in the past 12 months or during LTA (p = 0.005), weekly albumin dose (p = 0.014) and serum albumin concentration of 40 g/L after 1 month of treatment (p = 0.017). Of the 83 patients with refractory ascites at inclusion, 26% had grade 0/1 ascites at the last observation. No severe albumin-related side-effects were reported and only 1% discontinued for logistical reasons. Conclusions: LTA is feasible as an outpatient treatment for the management of ascites. In the current study, ascites resolved in more than half of patients receiving LTA on top of diuretics, including in some with refractory ascites. Predictors of response to LTA provide useful information for tailoring treatment. Impact and implications:: The ANSWER randomised-controlled trial has shown that long-term albumin treatment (LTA) is an effective approach for the management of patients with cirrhosis and ascites. This observational study provides novel information on target patients, modalities and length of treatment, predictors of ascites resolution, stopping criteria, and clinical trajectories of patients on treatment. LTA is a feasible option in the daily clinical practice for the management of ascites when given on top of diuretics. Rather than an alternative therapy, LTA should be integrated with the other treatment options already available for patients with difficult-to-treat ascites. The predictive factors of response identified in the present study can help physicians to individualise LTA and optimise the decision-making process.http://www.sciencedirect.com/science/article/pii/S2589555924002258decompensated cirrhosisascitesportal hypertensionhuman albuminTIPSparacentesis |
| spellingShingle | Enrico Pompili Giacomo Zaccherini Salvatore Piano Pierluigi Toniutto Antonio Lombardo Stefania Gioia Giulia Iannone Clara De Venuto Marta Tonon Roberta Gagliardi Maurizio Baldassarre Greta Tedesco Giorgio Bedogni Marco Domenicali Vito Di Marco Silvia Nardelli Vincenza Calvaruso Davide Bitetto Paolo Angeli Paolo Caraceni Real-world experience with long-term albumin in patients with cirrhosis and ascites JHEP Reports decompensated cirrhosis ascites portal hypertension human albumin TIPS paracentesis |
| title | Real-world experience with long-term albumin in patients with cirrhosis and ascites |
| title_full | Real-world experience with long-term albumin in patients with cirrhosis and ascites |
| title_fullStr | Real-world experience with long-term albumin in patients with cirrhosis and ascites |
| title_full_unstemmed | Real-world experience with long-term albumin in patients with cirrhosis and ascites |
| title_short | Real-world experience with long-term albumin in patients with cirrhosis and ascites |
| title_sort | real world experience with long term albumin in patients with cirrhosis and ascites |
| topic | decompensated cirrhosis ascites portal hypertension human albumin TIPS paracentesis |
| url | http://www.sciencedirect.com/science/article/pii/S2589555924002258 |
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