eb68b27206821680a009dac0b9c86002 264742.pdf c3dc31bc43a639de1631671d90d5b524eb833bc8 264742.pdf 596ee1c1bd841d9e76933506b55b9f0086075e84a01eb530eb73a5f0185f58fa 264742.pdf Title: Effects of Albumin on Survival after a Hepatic Encephalopathy Episode: Randomized Double-Blind Trial and Meta-Analysis Subject: 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. Keywords: clinical trial; meta-analysis; albumin; hepatic encephalopathy Author: Meritxell Ventura-Cots, Macarena Simón-Talero, Maria Poca, Xavier Ariza, Helena Masnou, Jordi Sanchez, Elba Llop, Núria Cañete, Marta Martín-Llahí, Alberto Amador, Javier Martínez, Ana Clemente-Sanchez, Angela Puente, Maria Torrens, Edilmar Alvarado-Tapias, Laura Napoleone, Mireia Miquel-Planas, Alba Ardèvol, Meritxell Casas Rodrigo, Jose Luís Calleja, Cristina Solé, German Soriano and Joan Genescà Creator: LaTeX with hyperref Producer: pdfTeX-1.40.21 CreationDate: Thu Nov 4 10:05:34 2021 CET ModDate: Thu Nov 4 10:24:25 2021 CET Tagged: no UserProperties: no Suspects: no Form: none JavaScript: no Pages: 12 Encrypted: no Page size: 595.276 x 841.89 pts (A4) Page rot: 0 File size: 1143233 bytes Optimized: no PDF version: 1.7 name type encoding emb sub uni object ID ------------------------------------ ----------------- ---------------- --- --- --- --------- YQMKHR+VnURWPalladioL Type 1 Custom yes yes no 10 0 SRPALS+URWPalladioL-Ital Type 1 Custom yes yes no 15 0 DBXADG+URWPalladioL-Bold Type 1 Custom yes yes no 20 0 EPQQYT+URWPalladioL-Roma Type 1 Custom yes yes no 24 0 OJOZIL+VnURWPalladioL-Bold Type 1 Custom yes yes no 28 0 XPUSBJ+TimesNewRomanPS-BoldItalicMT Type 1C WinAnsi yes yes no 36 0 BSDWLC+TimesNewRomanPSMT Type 1C WinAnsi yes yes no 39 0 MCBCCI+SourceSansRoman-Regular Type 1C Custom yes yes no 61 0 MCBCCM+SourceSansRoman.613wght Type 1C Custom yes yes no 65 0 MCBCCO+SourceSansRoman-Bold Type 1C Custom yes yes no 69 0 PDTLUH+CMSY10 Type 1 Builtin yes yes no 81 0 ZIPEAN+EURM10 Type 1 Builtin yes yes no 88 0 URYLRZ+URWPalladioL-BoldItal Type 1 Custom yes yes no 99 0 JQNTEN+MSAM10 Type 1 Builtin yes yes no 113 0 Jhove (Rel. 1.22.1, 2019-04-17) Date: 2023-05-27 03:21:38 CEST RepresentationInformation: 264742.pdf ReportingModule: PDF-hul, Rel. 1.12.1 (2019-04-17) LastModified: 2023-03-31 11:59:23 CEST Size: 1143233 Format: PDF Version: 1.7 Status: Well-Formed and valid SignatureMatches: PDF-hul MIMEtype: application/pdf PDFMetadata: Objects: 250 FreeObjects: 7 IncrementalUpdates: 0 DocumentCatalog: PageLayout: SinglePage PageMode: UseNone Outlines: Item: Title: Introduction Destination: edu.harvard.hul.ois.jhove.module.pdf.PdfSimpleObject@44c8afef Item: Title: Materials and Methods Destination: edu.harvard.hul.ois.jhove.module.pdf.PdfSimpleObject@7b69c6ba Children: Item: Title: Albumin Infusion Effect in Hepatic Encephalopathy (BETA) Destination: edu.harvard.hul.ois.jhove.module.pdf.PdfSimpleObject@46daef40 Item: Title: Patient Selection Destination: edu.harvard.hul.ois.jhove.module.pdf.PdfSimpleObject@12f41634 Item: Title: Study Protocol Destination: edu.harvard.hul.ois.jhove.module.pdf.PdfSimpleObject@13c27452 Item: Title: Outcome Destination: edu.harvard.hul.ois.jhove.module.pdf.PdfSimpleObject@262b2c86 Item: Title: Statistics Destination: edu.harvard.hul.ois.jhove.module.pdf.PdfSimpleObject@371a67ec Item: Title: Metanalysis: Albumin Infusion Effect in Hepatic Encephalopathy (BETA) and Effects of Intravenous Albumin in Patients with Cirrhosis and Episodic Hepatic Encephalopathy (ALFAE) Destination: edu.harvard.hul.ois.jhove.module.pdf.PdfSimpleObject@5ed828d Item: Title: Statistics Destination: edu.harvard.hul.ois.jhove.module.pdf.PdfSimpleObject@50d0686 Item: Title: Results Destination: edu.harvard.hul.ois.jhove.module.pdf.PdfSimpleObject@7a3d45bd Children: Item: Title: Basal Clinical Characteristics Destination: edu.harvard.hul.ois.jhove.module.pdf.PdfSimpleObject@1e7c7811 Item: Title: Complications during Follow-Up Destination: edu.harvard.hul.ois.jhove.module.pdf.PdfSimpleObject@77ec78b9 Item: Title: Survival Destination: edu.harvard.hul.ois.jhove.module.pdf.PdfSimpleObject@1a3869f4 Item: Title: Safety and Tolerability Destination: edu.harvard.hul.ois.jhove.module.pdf.PdfSimpleObject@a38d7a3 Item: Title: Meta-Analysis Results: BETA and ALFAE Studies Destination: edu.harvard.hul.ois.jhove.module.pdf.PdfSimpleObject@77f99a05 Item: Title: Discussion Destination: edu.harvard.hul.ois.jhove.module.pdf.PdfSimpleObject@63440df3 Item: Title: References Destination: edu.harvard.hul.ois.jhove.module.pdf.PdfSimpleObject@3aeaafa6 Info: Title: Effects of Albumin on Survival after a Hepatic Encephalopathy Episode: Randomized Double-Blind Trial and Meta-Analysis Author: Meritxell Ventura-Cots, Macarena Simón-Talero, Maria Poca, Xavier Ariza, Helena Masnou, Jordi Sanchez, Elba Llop, Núria Cañete, Marta Martín-Llahí, Alberto Amador, Javier Martínez, Ana Clemente-Sanchez, Angela Puente, Maria Torrens, Edilmar Alvarado-Tapias, Laura Napoleone, Mireia Miquel-Planas, Alba Ardèvol, Meritxell Casas Rodrigo, Jose Luís Calleja, Cristina Solé, German Soriano and Joan Genescà Subject: 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. 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