A Randomized Trial of Albumin Infusions in Hospitalized Patients with Cirrhosis.

Adult Albumins / administration & dosage Ascites / etiology Female Hospitalization Humans Infusions, Intravenous Liver Cirrhosis / blood Liver Cirrhosis, Alcoholic / blood Male Middle Aged Pulmonary Edema / etiology Serum Albumin Treatment Failure

Journal

The New England journal of medicine
ISSN: 1533-4406
Titre abrégé: N Engl J Med
Pays: United States
ID NLM: 0255562

Informations de publication

Date de publication:
04 03 2021
Historique:
entrez: 3 3 2021
pubmed: 4 3 2021
medline: 10 3 2021
Statut: ppublish

Résumé

Infection and increased systemic inflammation cause organ dysfunction and death in patients with decompensated cirrhosis. Preclinical studies provide support for an antiinflammatory role of albumin, but confirmatory large-scale clinical trials are lacking. Whether targeting a serum albumin level of 30 g per liter or greater in these patients with repeated daily infusions of 20% human albumin solution, as compared with standard care, would reduce the incidences of infection, kidney dysfunction, and death is unknown. We conducted a randomized, multicenter, open-label, parallel-group trial involving hospitalized patients with decompensated cirrhosis who had a serum albumin level of less than 30 g per liter at enrollment. Patients were randomly assigned to receive either targeted 20% human albumin solution for up to 14 days or until discharge, whichever came first, or standard care. Treatment commenced within 3 days after admission. The composite primary end point was new infection, kidney dysfunction, or death between days 3 and 15 after the initiation of treatment. A total of 777 patients underwent randomization, and alcohol was reported to be a cause of cirrhosis in most of these patients. A median total infusion of albumin of 200 g (interquartile range, 140 to 280) per patient was administered to the targeted albumin group (increasing the albumin level to ≥30 g per liter), as compared with a median of 20 g (interquartile range, 0 to 120) per patient administered to the standard-care group (adjusted mean difference, 143 g; 95% confidence interval [CI], 127 to 158.2). The percentage of patients with a primary end-point event did not differ significantly between the targeted albumin group (113 of 380 patients [29.7%]) and the standard-care group (120 of 397 patients [30.2%]) (adjusted odds ratio, 0.98; 95% CI, 0.71 to 1.33; P = 0.87). A time-to-event analysis in which data were censored at the time of discharge or at day 15 also showed no significant between-group difference (hazard ratio, 1.04; 95% CI, 0.81 to 1.35). More severe or life-threatening serious adverse events occurred in the albumin group than in the standard-care group. In patients hospitalized with decompensated cirrhosis, albumin infusions to increase the albumin level to a target of 30 g per liter or more was not more beneficial than the current standard care in the United Kingdom. (Funded by the Health Innovation Challenge Fund; ATTIRE EudraCT number, 2014-002300-24; ISRCT number, N14174793.).

Sections du résumé

BACKGROUND
Infection and increased systemic inflammation cause organ dysfunction and death in patients with decompensated cirrhosis. Preclinical studies provide support for an antiinflammatory role of albumin, but confirmatory large-scale clinical trials are lacking. Whether targeting a serum albumin level of 30 g per liter or greater in these patients with repeated daily infusions of 20% human albumin solution, as compared with standard care, would reduce the incidences of infection, kidney dysfunction, and death is unknown.
METHODS
We conducted a randomized, multicenter, open-label, parallel-group trial involving hospitalized patients with decompensated cirrhosis who had a serum albumin level of less than 30 g per liter at enrollment. Patients were randomly assigned to receive either targeted 20% human albumin solution for up to 14 days or until discharge, whichever came first, or standard care. Treatment commenced within 3 days after admission. The composite primary end point was new infection, kidney dysfunction, or death between days 3 and 15 after the initiation of treatment.
RESULTS
A total of 777 patients underwent randomization, and alcohol was reported to be a cause of cirrhosis in most of these patients. A median total infusion of albumin of 200 g (interquartile range, 140 to 280) per patient was administered to the targeted albumin group (increasing the albumin level to ≥30 g per liter), as compared with a median of 20 g (interquartile range, 0 to 120) per patient administered to the standard-care group (adjusted mean difference, 143 g; 95% confidence interval [CI], 127 to 158.2). The percentage of patients with a primary end-point event did not differ significantly between the targeted albumin group (113 of 380 patients [29.7%]) and the standard-care group (120 of 397 patients [30.2%]) (adjusted odds ratio, 0.98; 95% CI, 0.71 to 1.33; P = 0.87). A time-to-event analysis in which data were censored at the time of discharge or at day 15 also showed no significant between-group difference (hazard ratio, 1.04; 95% CI, 0.81 to 1.35). More severe or life-threatening serious adverse events occurred in the albumin group than in the standard-care group.
CONCLUSIONS
In patients hospitalized with decompensated cirrhosis, albumin infusions to increase the albumin level to a target of 30 g per liter or more was not more beneficial than the current standard care in the United Kingdom. (Funded by the Health Innovation Challenge Fund; ATTIRE EudraCT number, 2014-002300-24; ISRCT number, N14174793.).

Identifiants

DOI: 10.1056/NEJMoa2022166 PMID: 33657293
pubmed: 33657293
doi: 10.1056/NEJMoa2022166
doi:

Substances chimiques

Albumins 0
Serum Albumin 0

Banques de données

EudraCT
['2014-002300-24']
ISRCTN
['14174793']

Types de publication

Journal Article Multicenter Study Randomized Controlled Trial Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

808-817

Investigateurs

Dominique Valla (D)
Tim Clayton (T)
Vipul Jairath (V)
Kate Bennett (K)
Scott Bevan (S)
James Blackstone (J)
Kashfia Chowdhury (K)
Zainib Shabir (Z)
Simon Skene (S)
Stephen J Brett (SJ)
John Crookenden (J)
Shahid A Khan (SA)
Brennan Kahan (B)
Graeme Alexander (G)
Humphrey Hodgson (H)
Mike Murphy (M)
Louise China (L)
Ewan H Forrest (EH)
Yiannis Kallis (Y)
Jim Portal (J)
Stephen Ryder (S)
Gavin Wright (G)
Ana Arbeloa Del Moral (A)
Ana Carolina Estevao (AC)
Rosie Hamilton (R)
Khadra Mohamoud (K)
Nicola Muirhead (N)
Mauro Bernardi (M)
Paula Milton (P)
Nicola Shepherd (N)
Indran Balakrishnan (I)
Mark McPhail (M)
Brian Hogan (B)
Jane Abbott (J)
Aftab Ala (A)
Richard Aspinall (R)
Andrew Austin (A)
C Lye Ch'ng (CL)
Jeremy Cobbold (J)
Lynsey Corless (L)
Alexandra Daley (A)
Matthew Cramp (M)
Ahmed Elsharkawy (A)
Alex Evans (A)
Graham Foster (G)
Shaun Greer (S)
Mathis Heydtmann (M)
Coral Hollywood (C)
Peter Isaacs (P)
Rajiv Jalan (R)
Richard Keld (R)
Andrew King (A)
Stuart McPherson (S)
Judith Morris (J)
Jane Metcalf (J)
Richard Parker (R)
Janisha Patel (J)
Francisco Porraz-Perez (F)
Praveen Rajasekhar (P)
John Ramage (J)
Paul Richardson (P)
Dariush Sadigh (D)
Deepak Suri (D)
Esther Unit (E)
Sumita Verma (S)
Earl Williams (E)

Commentaires et corrections

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Informations de copyright

Copyright © 2021 Massachusetts Medical Society.

Auteurs

Louise China (L)

From the Institute for Liver and Digestive Health (L.C., N.B.S., A.O.), the Comprehensive Clinical Trials Unit (N.F.), and the Division of Medicine, University College London (D.W.G.), Barts and the London School of Medicine and Dentistry, Queen Mary University of London (Y.K.), London, the Glasgow Royal Infirmary and the University of Glagow, Glasgow (E.F.), the National Institute for Health Research Nottingham Biomedical Research Centre at Nottingham University Hospitals NHS Trust and the University of Nottingham, Queens Medical Centre, Nottingham (S.D.R.), the Mid and South Essex NHS Foundation Trust and the Basildon and Thurrock University Hospitals NHS Foundation Trust, Basildon (G.W.), and the Bristol Royal Infirmary, Bristol (A.J.P.) - all in the United Kingdom.

Nick Freemantle (N)

From the Institute for Liver and Digestive Health (L.C., N.B.S., A.O.), the Comprehensive Clinical Trials Unit (N.F.), and the Division of Medicine, University College London (D.W.G.), Barts and the London School of Medicine and Dentistry, Queen Mary University of London (Y.K.), London, the Glasgow Royal Infirmary and the University of Glagow, Glasgow (E.F.), the National Institute for Health Research Nottingham Biomedical Research Centre at Nottingham University Hospitals NHS Trust and the University of Nottingham, Queens Medical Centre, Nottingham (S.D.R.), the Mid and South Essex NHS Foundation Trust and the Basildon and Thurrock University Hospitals NHS Foundation Trust, Basildon (G.W.), and the Bristol Royal Infirmary, Bristol (A.J.P.) - all in the United Kingdom.

Ewan Forrest (E)

From the Institute for Liver and Digestive Health (L.C., N.B.S., A.O.), the Comprehensive Clinical Trials Unit (N.F.), and the Division of Medicine, University College London (D.W.G.), Barts and the London School of Medicine and Dentistry, Queen Mary University of London (Y.K.), London, the Glasgow Royal Infirmary and the University of Glagow, Glasgow (E.F.), the National Institute for Health Research Nottingham Biomedical Research Centre at Nottingham University Hospitals NHS Trust and the University of Nottingham, Queens Medical Centre, Nottingham (S.D.R.), the Mid and South Essex NHS Foundation Trust and the Basildon and Thurrock University Hospitals NHS Foundation Trust, Basildon (G.W.), and the Bristol Royal Infirmary, Bristol (A.J.P.) - all in the United Kingdom.

Yiannis Kallis (Y)

From the Institute for Liver and Digestive Health (L.C., N.B.S., A.O.), the Comprehensive Clinical Trials Unit (N.F.), and the Division of Medicine, University College London (D.W.G.), Barts and the London School of Medicine and Dentistry, Queen Mary University of London (Y.K.), London, the Glasgow Royal Infirmary and the University of Glagow, Glasgow (E.F.), the National Institute for Health Research Nottingham Biomedical Research Centre at Nottingham University Hospitals NHS Trust and the University of Nottingham, Queens Medical Centre, Nottingham (S.D.R.), the Mid and South Essex NHS Foundation Trust and the Basildon and Thurrock University Hospitals NHS Foundation Trust, Basildon (G.W.), and the Bristol Royal Infirmary, Bristol (A.J.P.) - all in the United Kingdom.

Stephen D Ryder (SD)

From the Institute for Liver and Digestive Health (L.C., N.B.S., A.O.), the Comprehensive Clinical Trials Unit (N.F.), and the Division of Medicine, University College London (D.W.G.), Barts and the London School of Medicine and Dentistry, Queen Mary University of London (Y.K.), London, the Glasgow Royal Infirmary and the University of Glagow, Glasgow (E.F.), the National Institute for Health Research Nottingham Biomedical Research Centre at Nottingham University Hospitals NHS Trust and the University of Nottingham, Queens Medical Centre, Nottingham (S.D.R.), the Mid and South Essex NHS Foundation Trust and the Basildon and Thurrock University Hospitals NHS Foundation Trust, Basildon (G.W.), and the Bristol Royal Infirmary, Bristol (A.J.P.) - all in the United Kingdom.

Gavin Wright (G)

From the Institute for Liver and Digestive Health (L.C., N.B.S., A.O.), the Comprehensive Clinical Trials Unit (N.F.), and the Division of Medicine, University College London (D.W.G.), Barts and the London School of Medicine and Dentistry, Queen Mary University of London (Y.K.), London, the Glasgow Royal Infirmary and the University of Glagow, Glasgow (E.F.), the National Institute for Health Research Nottingham Biomedical Research Centre at Nottingham University Hospitals NHS Trust and the University of Nottingham, Queens Medical Centre, Nottingham (S.D.R.), the Mid and South Essex NHS Foundation Trust and the Basildon and Thurrock University Hospitals NHS Foundation Trust, Basildon (G.W.), and the Bristol Royal Infirmary, Bristol (A.J.P.) - all in the United Kingdom.

Andrew J Portal (AJ)

From the Institute for Liver and Digestive Health (L.C., N.B.S., A.O.), the Comprehensive Clinical Trials Unit (N.F.), and the Division of Medicine, University College London (D.W.G.), Barts and the London School of Medicine and Dentistry, Queen Mary University of London (Y.K.), London, the Glasgow Royal Infirmary and the University of Glagow, Glasgow (E.F.), the National Institute for Health Research Nottingham Biomedical Research Centre at Nottingham University Hospitals NHS Trust and the University of Nottingham, Queens Medical Centre, Nottingham (S.D.R.), the Mid and South Essex NHS Foundation Trust and the Basildon and Thurrock University Hospitals NHS Foundation Trust, Basildon (G.W.), and the Bristol Royal Infirmary, Bristol (A.J.P.) - all in the United Kingdom.

Natalia Becares Salles (N)

From the Institute for Liver and Digestive Health (L.C., N.B.S., A.O.), the Comprehensive Clinical Trials Unit (N.F.), and the Division of Medicine, University College London (D.W.G.), Barts and the London School of Medicine and Dentistry, Queen Mary University of London (Y.K.), London, the Glasgow Royal Infirmary and the University of Glagow, Glasgow (E.F.), the National Institute for Health Research Nottingham Biomedical Research Centre at Nottingham University Hospitals NHS Trust and the University of Nottingham, Queens Medical Centre, Nottingham (S.D.R.), the Mid and South Essex NHS Foundation Trust and the Basildon and Thurrock University Hospitals NHS Foundation Trust, Basildon (G.W.), and the Bristol Royal Infirmary, Bristol (A.J.P.) - all in the United Kingdom.

Derek W Gilroy (DW)

From the Institute for Liver and Digestive Health (L.C., N.B.S., A.O.), the Comprehensive Clinical Trials Unit (N.F.), and the Division of Medicine, University College London (D.W.G.), Barts and the London School of Medicine and Dentistry, Queen Mary University of London (Y.K.), London, the Glasgow Royal Infirmary and the University of Glagow, Glasgow (E.F.), the National Institute for Health Research Nottingham Biomedical Research Centre at Nottingham University Hospitals NHS Trust and the University of Nottingham, Queens Medical Centre, Nottingham (S.D.R.), the Mid and South Essex NHS Foundation Trust and the Basildon and Thurrock University Hospitals NHS Foundation Trust, Basildon (G.W.), and the Bristol Royal Infirmary, Bristol (A.J.P.) - all in the United Kingdom.

Alastair O'Brien (A)

From the Institute for Liver and Digestive Health (L.C., N.B.S., A.O.), the Comprehensive Clinical Trials Unit (N.F.), and the Division of Medicine, University College London (D.W.G.), Barts and the London School of Medicine and Dentistry, Queen Mary University of London (Y.K.), London, the Glasgow Royal Infirmary and the University of Glagow, Glasgow (E.F.), the National Institute for Health Research Nottingham Biomedical Research Centre at Nottingham University Hospitals NHS Trust and the University of Nottingham, Queens Medical Centre, Nottingham (S.D.R.), the Mid and South Essex NHS Foundation Trust and the Basildon and Thurrock University Hospitals NHS Foundation Trust, Basildon (G.W.), and the Bristol Royal Infirmary, Bristol (A.J.P.) - all in the United Kingdom.

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Classifications MeSH

questionsmedicales.fr › Personnes › Tranches d'âge › Adulte › A Randomized Trial of Albumin Infusions in...
questionsmedicales.fr › Acides aminés, peptides et protéines › Protéines › Albumines › A Randomized Trial of Albumin Infusions in...
questionsmedicales.fr › États, signes et symptômes pathologiques › Processus pathologiques › Ascites › A Randomized Trial of Albumin Infusions in...
questionsmedicales.fr › Établissements, main d'oeuvre et services de soins de santé › Services de santé › Soins aux patients › Hospitalisation › A Randomized Trial of Albumin Infusions in...
questionsmedicales.fr › Eucaryotes › Animaux › Chordés › Vertébrés › Mammifères › Eutheria › Primates › Haplorhini › Catarrhini › Hominidae › Humains › A Randomized Trial of Albumin Infusions in...
questionsmedicales.fr › Thérapeutique › Traitement médicamenteux › Voies d'administration de substances chimiques et des médicaments › Perfusions parentérales › Perfusions veineuses › A Randomized Trial of Albumin Infusions in...
questionsmedicales.fr › États, signes et symptômes pathologiques › Processus pathologiques › Fibrose › Cirrhose du foie › A Randomized Trial of Albumin Infusions in...
questionsmedicales.fr › Troubles dus à des produits chimiques › Troubles dus à l'abus d'alcool › Maladies alcooliques du foie › Cirrhose alcoolique › A Randomized Trial of Albumin Infusions in...
questionsmedicales.fr › Personnes › Tranches d'âge › Adulte › Adulte d'âge moyen › A Randomized Trial of Albumin Infusions in...
questionsmedicales.fr › Maladies de l'appareil respiratoire › Maladies pulmonaires › Oedème pulmonaire › A Randomized Trial of Albumin Infusions in...
questionsmedicales.fr › Acides aminés, peptides et protéines › Protéines › Protéines du sang › Sérumalbumine › A Randomized Trial of Albumin Infusions in...
questionsmedicales.fr › Qualité, accès, évaluation des soins de santé › Qualité des soins de santé › Mécanismes d'évaluation des soins de santé › Évaluation des résultats et des processus en soins de santé › Évaluation de résultat (soins) › Résultat thérapeutique › Échec thérapeutique › A Randomized Trial of Albumin Infusions in...