Thierry Thévenot1, Christophe Bureau2, Frédéric Oberti3, Rodolphe Anty4, Alexandre Louvet5, Aurélie Plessier6, Marika Rudler7, Alexandra Heurgué-Berlot8, Isabelle Rosa9, Nathalie Talbodec10, Thong Dao11, Violaine Ozenne12, Nicolas Carbonell13, Xavier Causse14, Odile Goria15, Anne Minello16, Victor De Ledinghen17, Roland Amathieu18, Hélène Barraud19, Eric Nguyen-Khac20, Claire Becker21, Thierry Paupard22, Danielle Botta-Fridlung23, Naceur Abdelli24, François Guillemot25, Elisabeth Monnet26, Vincent Di Martino26. 1. Service d'Hépatologie, hôpital Jean Minjoz, 25000 Besançon, France. Electronic address: tthevenot@chu-besancon.fr. 2. Service d'Hépato-Gastroentérologie, hôpital Purpan, clinique Dieulafoy, 31059 Toulouse, France. 3. Service d' d'Hépato-Gastroentérologie, hôpital d'Angers, 4 rue Larrey, 49100 Angers, France. 4. Service d'Hépato-Gastroentérologie, hôpital Archet, rue St Antoine Ginestier, 06200 Nice, France. 5. Service des Maladies de l'Appareil Digestif, CHRU de Lille, rue M. Polonovs.ki, 59037 Lille cedex, France. 6. Inserm U-773, Service d'Hépatologie, hôpital Beaujon, 100 boulevard du Général Leclerc, 92118 Clichy cédex, France. 7. Service d'Hépato-Gastroentérologie, hôpital Pitié-Salpétrière, 47-83 boulevard de l'Hôpital, 75651 Paris cedex 13, France. 8. Service d'Hépato-Gastroentérologie, hôpital Robert Debré, 51092 Reims cedex, France. 9. Service d'Hépato-Gastroentérologie, CHIC de Créteil, 40 avenue de Verdun, 94010 Créteil cedex, France. 10. Service d'Hépato-Gastroentérologie, centre hospitalier, 135 rue du Président Coty, 59 200 Tourcoing, France. 11. Inserm U-1075, Service d'Hépato-Gastroentérologie, hôpital de Caen, avenue de la Côte de Nacre, 14000 Caen, France. 12. Service d'Hépato-Gastroentérologie, hôpital Lariboisière, 2 rue Ambroise-Paré, 75010 Paris, France. 13. Service d'Hépato-Gastroentérologie, hôpital Saint-Antoine, 184 rue du Fbg St Antoine, 75571 Paris cedex 12, France. 14. Service d'Hépato-Gastroentérologie, hôpital de la Source, BP 6709, 45067 Orléans cedex 12, France. 15. Service d'Hépato-Gastroentérologie, hôpital de Rouen, 1 Rue Germont, 76000 Rouen, France. 16. Service d'Hépato-Gastroentérologie, hôpital du Bocage, BP 1542, 21034 Dijon cedex, France. 17. Service d'Hépato-Gastroentérologie, hôpital du haut Levêque, 33604 Pessac cedex, France. 18. Service d'Hépato-Gastroentérologie, hôpital Jean Verdier, av. du 14 juillet, 93143 Bondy cedex, France. 19. Service d'Hépato-Gastroentérologie, hôpital de Brabois, rue du Morvan, 54511 Vandoeuvre-les-Nancy cedex, France. 20. Service d'Hépato-Gastroentérologie, hôpital d'Amiens, 2 Place Victor Pauchet, 80080 Amiens, France. 21. Service d'Hépato-Gastroentérologie, hôpital de Lens, 99 route de la Bassée, SP-8, 62307 Lens cedex, France. 22. Service d'Hépato-Gastroentérologie, hôpital de Dunkerque, 130 avenue Louis Herbeaux, 59385 Dunkerque cedex 1, France. 23. Service d'Hépato-Gastroentérologie, hôpital de la Conception, 147 Bd Baille, 13005 Marseille, France. 24. Service d'Hépato-Gastroentérologie, hôpital de Chalons-en-Champagne, 51 rue du commandant Derrien, 51005 Chalons-en-Champagne cedex, France. 25. Service d'Hépato-Gastroentérologie, hôpital de Roubaix, 11-17 Boulevard Lacordaire, 59100 Roubaix, France. 26. Service d'Hépatologie, hôpital Jean Minjoz, 25000 Besançon, France.
Abstract
BACKGROUND & AIMS:Albumin infusion improves renal function and survival in cirrhotic patients with spontaneous bacterial peritonitis (SBP) but its efficacy in other types of infections remains unknown. We investigated this issue through a multicenter randomized controlled trial. METHODS: A total of 193 cirrhotic patients with a Child-Pugh score greater than 8 and sepsis unrelated to SBP were randomly assigned to receive antibiotics plus albumin (1.5 g/kg on day 1 and 1g/kg on day 3; albumin group [ALB]: n=96) or antibiotics alone (control group [CG]: n=97). The primary endpoint was the 3-month renal failure rate (increase in creatinine ⩾50% to reach a final value ⩾133 μmol/L). The secondary endpoint was 3-month survival rate. RESULTS:Forty-seven (24.6%) patients died (ALB: n=27 vs. CG: n=20; 3-month survival: 70.2% vs. 78.3%; p=0.16). Albumin infusion delayed the occurrence of renal failure (mean time to onset, ALB: 29.0 ± 21.8 vs. 11.7 ± 9.1 days, p=0.018) but the 3-month renal failure rate was similar (ALB: 14.3% vs. CG: 13.5%; p=0.88). By multivariate analysis, MELD score (p<0.0001), pneumonia (p=0.0041), hyponatremia (p=0.031) and occurrence of renal failure (p<0.0001) were predictors of death. Of note, pulmonary edema developed in 8/96 (8.3%) patients in the albumin group of whom two died, one on the day and the other on day 33 following albumin infusion. CONCLUSIONS: In cirrhotic patients with infections other than SBP, albumin infusion delayed onset of renal failure but did not improve renal function or survival at 3 months. Infusion of large amounts of albumin should be cautiously administered in the sickest cirrhotic patients.
RCT Entities:
BACKGROUND & AIMS: Albumin infusion improves renal function and survival in cirrhotic patients with spontaneous bacterial peritonitis (SBP) but its efficacy in other types of infections remains unknown. We investigated this issue through a multicenter randomized controlled trial. METHODS: A total of 193 cirrhotic patients with a Child-Pugh score greater than 8 and sepsis unrelated to SBP were randomly assigned to receive antibiotics plus albumin (1.5 g/kg on day 1 and 1g/kg on day 3; albumin group [ALB]: n=96) or antibiotics alone (control group [CG]: n=97). The primary endpoint was the 3-month renal failure rate (increase in creatinine ⩾50% to reach a final value ⩾133 μmol/L). The secondary endpoint was 3-month survival rate. RESULTS: Forty-seven (24.6%) patients died (ALB: n=27 vs. CG: n=20; 3-month survival: 70.2% vs. 78.3%; p=0.16). Albumin infusion delayed the occurrence of renal failure (mean time to onset, ALB: 29.0 ± 21.8 vs. 11.7 ± 9.1 days, p=0.018) but the 3-month renal failure rate was similar (ALB: 14.3% vs. CG: 13.5%; p=0.88). By multivariate analysis, MELD score (p<0.0001), pneumonia (p=0.0041), hyponatremia (p=0.031) and occurrence of renal failure (p<0.0001) were predictors of death. Of note, pulmonary edema developed in 8/96 (8.3%) patients in the albumin group of whom two died, one on the day and the other on day 33 following albumin infusion. CONCLUSIONS: In cirrhotic patients with infections other than SBP, albumin infusion delayed onset of renal failure but did not improve renal function or survival at 3 months. Infusion of large amounts of albumin should be cautiously administered in the sickest cirrhotic patients.
Authors: Rinaldo Bellomo; Claudio Ronco; Ravindra L Mehta; Pierre Asfar; Julie Boisramé-Helms; Michael Darmon; Jean-Luc Diehl; Jacques Duranteau; Eric A J Hoste; Joannes-Boyau Olivier; Matthieu Legrand; Nicolas Lerolle; Manu L N G Malbrain; Johan Mårtensson; Heleen M Oudemans-van Straaten; Jean-Jacques Parienti; Didier Payen; Sophie Perinel; Esther Peters; Peter Pickkers; Eric Rondeau; Miet Schetz; Christophe Vinsonneau; Julia Wendon; Ling Zhang; Pierre-François Laterre Journal: Ann Intensive Care Date: 2017-05-04 Impact factor: 6.925