Effects of Albumin on Survival after a Hepatic Encephalopathy Episode: Randomized Double-Blind Trial and Meta-Analysis
Por:
Ventura-Cots, M, Simon-Talero, M, Poca, M, Ariza, X, Masnou, H, Sanchez, J, Llop, E, Canete, N, Martin-Llahi, M, Amador, A, Martinez, J, Clemente-Sanchez, A, Puente, A, Torrens, M, Alvarado-Tapias, E, Napoleone, L, Miquel-Planas, M, Ardevol, A, Rodrigo, MC, Calleja, JL, Sole, C, Soriano, G, Genesca, J
Publicada:
1 nov 2021
Resumen:
No therapies have been proven to increase survival after a hepatic encephalopathy (HE) episode. We hypothesize that two doses of albumin could improve 90-day survival rates after a HE episode. Methods: (1) A randomized double-blind, placebo-controlled trial (BETA) was conducted in 12 hospitals. The effect of albumin (1.5 g/kg at baseline and 1 g/kg on day 3) on 90-day survival rates after a HE episode grade II or higher was evaluated. (2) A meta-analysis of individual patient's data for survival including two clinical trials (BETA and ALFAE) was performed. Results: In total, 82 patients were included. Albumin failed to increase the 90-day transplant-free survival (91.9% vs. 80.5%, p = 0.3). A competing risk analysis was performed, observing a 90-day cumulative incidence of death of 9% in the albumin group vs. 20% in the placebo (p = 0.1). The meta-analysis showed a benefit in the albumin group, with a lower rate of clinical events (death or liver transplant) than patients in the placebo (HR, 0.44; 95% CI, 0.21-0.82), when analyzed by a competing risk analysis (90-days mortality rate of 11% in the albumin group vs. 30% in the placebo, p = 0.02). Conclusions: Repeated doses of albumin might be beneficial for patient's survival as an add-on therapy after an HE episode, but an adequately powered trial is needed.
Filiaciones:
Ventura-Cots, M:
Univ Autonoma Barcelona, Hosp Univ Vall dHebron, Vall dHebron Barcelona Hosp Campus,Liver Unit, Vall dHebron Inst Recerca VHIR,Dept Internal Med, Barcelona 08035, Spain
Ctr Invest Biomed Red Enfermedades Hepat D, Inst Salud Carlos 3, Madrid 28029, Spain
Simon-Talero, M:
Univ Autonoma Barcelona, Hosp Univ Vall dHebron, Vall dHebron Barcelona Hosp Campus,Liver Unit, Vall dHebron Inst Recerca VHIR,Dept Internal Med, Barcelona 08035, Spain
Ctr Invest Biomed Red Enfermedades Hepat D, Inst Salud Carlos 3, Madrid 28029, Spain
Poca, M:
Univ Autonoma Barcelona, Hosp Santa Creu Sant Pau, Inst Recerca Hosp Santa Creu Sant Pau, Dept Gastroenterol, Barcelona 08041, Spain
Ctr Invest Biomed Red Enfermedades Hepat D, Inst Salud Carlos 3, Madrid 28029, Spain
Ariza, X:
Ctr Invest Biomed Red Enfermedades Hepat D, Inst Salud Carlos 3, Madrid 28029, Spain
Hosp Clin Barcelona, Liver Unit, Barcelona 08036, Spain
Masnou, H:
Hosp Univ Germans Tries Pujol, Dept Gastroenterol, Badalona 08916, Spain
Sanchez, J:
Ctr Invest Biomed Red Enfermedades Hepat D, Inst Salud Carlos 3, Madrid 28029, Spain
Corporacio Sanitaria Parc Tauli, Dept Gastroenterol, Sabadell 08208, Spain
Llop, E:
Ctr Invest Biomed Red Enfermedades Hepat D, Inst Salud Carlos 3, Madrid 28029, Spain
Hosp Univ Puerta Hierro, Puerta Hierro Hlth Res Inst IDIPHIM, Madrid 28222, Spain
Canete, N:
Univ Autonoma Barcelona, Hosp Mar, Hosp Mar Med Res Inst IMIM, Dept Gastroenterol,Liver Sect, Barcelona 08003, Spain
Martin-Llahi, M:
Hosp Moises Broggi, Gastrointestinal Dept, Sant Joan Despi 08970, Spain
Amador, A:
Univ Barcelona, Bellvitge Hosp, LHosp Llobregat,Hepatol Unit, ICS,Gastroenterol Dept,Res Grp Hepato biliary & P, Barcelona 08907, Spain
Martinez, J:
Hosp Univ Ramon Cajal, Dept Gastroenterol, Madrid 28034, Spain
Clemente-Sanchez, A:
Ctr Invest Biomed Red Enfermedades Hepat D, Inst Salud Carlos 3, Madrid 28029, Spain
Univ Complutense Madrid, Hosp Gen Univ Gregorio Maranon, Digest Dept, Liver Unit, Madrid 28007, Spain
Puente, A:
Univ Hosp Marques Valdecilla, Inst Invest Sanitaria Valdecilla IDIVAL, Digest Dis Dept, Santander 39008, Spain
Torrens, M:
Univ Autonoma Barcelona, Hosp Univ Vall dHebron, Vall dHebron Barcelona Hosp Campus,Liver Unit, Vall dHebron Inst Recerca VHIR,Dept Internal Med, Barcelona 08035, Spain
Alvarado-Tapias, E:
Ctr Invest Biomed Red Enfermedades Hepat D, Inst Salud Carlos 3, Madrid 28029, Spain
Napoleone, L:
Ctr Invest Biomed Red Enfermedades Hepat D, Inst Salud Carlos 3, Madrid 28029, Spain
Hosp Clin Barcelona, Liver Unit, Barcelona 08036, Spain
Miquel-Planas, M:
Ctr Invest Biomed Red Enfermedades Hepat D, Inst Salud Carlos 3, Madrid 28029, Spain
Corporacio Sanitaria Parc Tauli, Dept Gastroenterol, Sabadell 08208, Spain
Univ Vic Univ Cent Catalunya UVIc UCC, Dept Med, Catalunya 08500, Vic, Spain
Ardevol, A:
Hosp Univ Germans Tries Pujol, Dept Gastroenterol, Badalona 08916, Spain
Rodrigo, MC:
Corporacio Sanitaria Parc Tauli, Dept Gastroenterol, Sabadell 08208, Spain
Calleja, JL:
Ctr Invest Biomed Red Enfermedades Hepat D, Inst Salud Carlos 3, Madrid 28029, Spain
Hosp Univ Puerta Hierro, Puerta Hierro Hlth Res Inst IDIPHIM, Madrid 28222, Spain
Sole, C:
Ctr Invest Biomed Red Enfermedades Hepat D, Inst Salud Carlos 3, Madrid 28029, Spain
Hosp Clin Barcelona, Liver Unit, Barcelona 08036, Spain
Corporacio Sanitaria Parc Tauli, Dept Gastroenterol, Sabadell 08208, Spain
Soriano, G:
Ctr Invest Biomed Red Enfermedades Hepat D, Inst Salud Carlos 3, Madrid 28029, Spain
Univ Autonoma Barcelona, Hosp Santa Creu Sant Pau, Inst Recerca Hosp Santa Creu Sant Pau, Dept Gastroenterol, Barcelona 08041, Spain
Genesca, J:
Univ Autonoma Barcelona, Hosp Univ Vall dHebron, Vall dHebron Barcelona Hosp Campus,Liver Unit, Vall dHebron Inst Recerca VHIR,Dept Internal Med, Barcelona 08035, Spain
Ctr Invest Biomed Red Enfermedades Hepat D, Inst Salud Carlos 3, Madrid 28029, Spain
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