Javier Fernández1, Paolo Angeli2, Jonel Trebicka3, Manuela Merli4, Thierry Gustot5, Carlo Alessandria6, Niels Kristian Aagaard7, Andrea de Gottardi8, Tania M Welzel9, Alexander Gerbes10, German Soriano11, Victor Vargas12, Agustin Albillos13, Francesco Salerno14, Francois Durand15, Rafael Bañares16, Rudolf Stauber17, Verónica Prado18, Mireya Arteaga18, María Hernández-Tejero18, Fátima Aziz18, Filippo Morando19, Christian Jansen20, Barbara Lattanzi4, Christophe Moreno5, Daniela Campion6, Henning Gronbaek7, Rita Garcia16, Cristina Sánchez21, Elisabet García21, Alex Amorós21, Marco Pavesi21, Joan Clària21, Richard Moreau22, Vicente Arroyo21. 1. EF Clif, EASL-CLIF Consortium and Grifols Chair, Barcelona, Spain; Hospital Clínic, IDIBAPS and CIBERehd, Barcelona, Spain. Electronic address: Jfdez@clinic.cat. 2. EF Clif, EASL-CLIF Consortium and Grifols Chair, Barcelona, Spain; University of Padua, Padua, Italy. 3. EF Clif, EASL-CLIF Consortium and Grifols Chair, Barcelona, Spain; University Hospital of Bonn, Bonn, Germany; Hospital University of Frankfurt, Frankfurt, Germany. 4. Sapienza University of Rome, Rome, Italy. 5. Department of Gastroenterology, Erasme Hospital (ULB), Brussels, Belgium. 6. Division of Gastroenterology and Hepatology, Città della Salute e della Scienza Hospital, University of Turin, Turin, Italy. 7. Aarhus University Hospital, Aarhus, Denmark. 8. University of Berne, Berne, Switzerland. 9. Hospital University of Frankfurt, Frankfurt, Germany. 10. University Medical School Munich, Munich, Germany. 11. Hospital of Santa Creu i Sant Pau, Barcelona, Spain. 12. Hospital Universitari Vall d'Hebron, Universitat Autonoma de Barcelona i CIBERehd, Barcelona, Spain. 13. Hospital Universitario Ramon y Cajal, Madrid, Spain. 14. Policlinico IRCCS San Donato, Milan, Italy. 15. Service d'Hépatologie, Hôpital Beaujon, Assistance Publique-Hôpitaux de Paris, Clichy, France. 16. Hospital Gregorio Marañon, Madrid, Spain. 17. Medical University of Graz, Graz, Austria. 18. Hospital Clínic, IDIBAPS and CIBERehd, Barcelona, Spain. 19. University of Padua, Padua, Italy. 20. University Hospital of Bonn, Bonn, Germany. 21. EF Clif, EASL-CLIF Consortium and Grifols Chair, Barcelona, Spain. 22. EF Clif, EASL-CLIF Consortium and Grifols Chair, Barcelona, Spain; Service d'Hépatologie, Hôpital Beaujon, Assistance Publique-Hôpitaux de Paris, Clichy, France; Inserm, Université Paris Diderot-Paris 7, CNRS, Centre de Recherche sur l'Inflammation, Paris, France.
Abstract
BACKGROUND & AIMS: We performed a randomized trial to determine whether albumin should be administered to patients with infections unrelated to spontaneous bacterial peritonitis (SBP). METHODS: We performed a multicenter, open-label trial in which 118 patients with cirrhosis, non-SBP infections, and additional risk factors for poor outcome were randomly assigned to receive antibiotics plus albumin (study group; n = 61) or antibiotics alone (control group; n = 57). The primary outcome was in-hospital mortality; secondary outcomes were effect of albumin on disease course. RESULTS: There were no significant differences at baseline between groups in results from standard laboratory tests, serum markers of inflammation, circulatory dysfunction, or liver severity scores. However, the combined prevalence of acute on chronic liver failure (ACLF) and kidney dysfunction was significantly higher in the study group (44.3% vs 24.6% in the control group; P = .02), indicating greater baseline overall severity. There was no significant difference in the primary outcome between groups (13.1% in the study group vs 10.5% in the control group; P = .66). Circulatory and renal functions improved in only the study group. A significantly higher proportion of patients in the study group had resolution of ACLF (82.3% vs 33.3% in the control group; P = .03). A significantly lower proportion of patients in the study group developed nosocomial infections (6.6% vs 24.6% in the control group; P = .007). CONCLUSIONS: In a randomized trial of patients with advanced cirrhosis and non-SBP infections, in-hospital mortality was similar between those who received albumin plus antibiotics vs those who received only antibiotics (controls). However, patients given albumin were sicker at baseline and, during the follow-up period, a higher proportion had ACLF resolution and a lower proportion had nosocomial infections. ClinicalTrials.gov no: NCT02034279.
RCT Entities:
BACKGROUND & AIMS: We performed a randomized trial to determine whether albumin should be administered to patients with infections unrelated to spontaneous bacterial peritonitis (SBP). METHODS: We performed a multicenter, open-label trial in which 118 patients with cirrhosis, non-SBP infections, and additional risk factors for poor outcome were randomly assigned to receive antibiotics plus albumin (study group; n = 61) or antibiotics alone (control group; n = 57). The primary outcome was in-hospital mortality; secondary outcomes were effect of albumin on disease course. RESULTS: There were no significant differences at baseline between groups in results from standard laboratory tests, serum markers of inflammation, circulatory dysfunction, or liver severity scores. However, the combined prevalence of acute on chronic liver failure (ACLF) and kidney dysfunction was significantly higher in the study group (44.3% vs 24.6% in the control group; P = .02), indicating greater baseline overall severity. There was no significant difference in the primary outcome between groups (13.1% in the study group vs 10.5% in the control group; P = .66). Circulatory and renal functions improved in only the study group. A significantly higher proportion of patients in the study group had resolution of ACLF (82.3% vs 33.3% in the control group; P = .03). A significantly lower proportion of patients in the study group developed nosocomial infections (6.6% vs 24.6% in the control group; P = .007). CONCLUSIONS: In a randomized trial of patients with advanced cirrhosis and non-SBP infections, in-hospital mortality was similar between those who received albumin plus antibiotics vs those who received only antibiotics (controls). However, patients given albumin were sicker at baseline and, during the follow-up period, a higher proportion had ACLF resolution and a lower proportion had nosocomial infections. ClinicalTrials.gov no: NCT02034279.
Authors: Lili Niu; Philipp E Geyer; Rajat Gupta; Alberto Santos; Florian Meier; Sophia Doll; Nicolai J Wewer Albrechtsen; Sabine Klein; Cristina Ortiz; Frank E Uschner; Robert Schierwagen; Jonel Trebicka; Matthias Mann Journal: Mol Syst Biol Date: 2022-05 Impact factor: 13.068