High-volume versus standard-volume haemofiltration for septic shock patients with acute kidney injury (IVOIRE study): a multicentre randomized controlled trial |
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Authors: | Olivier Joannes-Boyau Patrick M Honoré Paul Perez Sean M Bagshaw Hubert Grand Jean-Luc Canivet Antoine Dewitte Claire Flamens Wilfried Pujol Anne-Sophie Grandoulier Catherine Fleureau Rita Jacobs Christophe Broux Hervé Floch Olivier Branchard Stephane Franck Hadrien Rozé Vincent Collin Willem Boer Joachim Calderon Bernard Gauche Herbert D Spapen Gérard Janvier Alexandre Ouattara |
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Institution: | 1. Service d’Anesthésie-Réanimation 2, Centre Hospitalier Universitaire (CHU) de Bordeaux, 33000, Bordeaux, France 15. Haut-Lévèque Hospital, MHL, 3ème étage, 1, Avenue de Magellan, 33600, Pessac, France 2. Universitair Ziekenhuis Brussel, Vrije Universitieit Brussel (VUB), Brussels, Belgium 3. Unité de Soutien Méthodologique à la Recherche Clinique et épidémiologique (USMR), P?le de Santé Publique et CIC-EC7, Centre Hospitalier Universitaire (CHU) de Bordeaux, 33000, Bordeaux, France 4. Division of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta, Edmonton, AB, T6G 2B7, Canada 5. Réanimation Polyvalente, P?le EPURS, Hopital R. BOULIN, 33500, Libourne, France 6. Department of General Intensive Care, University Hospital of Liege, Domaine Universitaire de Liège, Liege, Belgium 7. Service d’Anesthésie et Réanimation, H?pital Cardiovasculaire et Pneumologique Louis Pradel, Lyon, France 8. Service de Réanimation, Clinique Bordeaux Nord Aquitaine, 33000, Bordeaux, France 9. Department of Anesthesiology and Critical Care, Albert Michallon Hospital, 38043, Grenoble, France 10. Réanimation Chirurgicale, H?pital de Cavale Blanche, CHU de Brest, 29609, Brest, France 11. Department of Critical Care, H?pital Tivoli, Université Libre de Bruxelles, La Louvière, Belgium 12. Cliniques de l’Europe-Site St Michel, Brussels, Belgium 13. Department of Anesthesiology and Critical Care Medicine, Ziekenhuis Oost-Limburg, Genk, Belgium 14. Univ. Bordeaux, Adaptation Cardiovasculaire à l’ischémie, U1034, 33600, Pessac, France
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Abstract: | Purpose Septic shock is a leading cause of death among critically ill patients, in particular when complicated by acute kidney injury (AKI). Small experimental and human clinical studies have suggested that high-volume haemofiltration (HVHF) may improve haemodynamic profile and mortality. We sought to determine the impact of HVHF on 28-day mortality in critically ill patients with septic shock and AKI. Methods This was a prospective, randomized, open, multicentre clinical trial conducted at 18 intensive care units in France, Belgium and the Netherlands. A total of 140 critically ill patients with septic shock and AKI for less than 24 h were enrolled from October 2005 through March 2010. Patients were randomized to either HVHF at 70 mL/kg/h or standard-volume haemofiltration (SVHF) at 35 mL/kg/h, for a 96-h period. Results Primary endpoint was 28-day mortality. The trial was stopped prematurely after enrolment of 140 patients because of slow patient accrual and resources no longer being available. A total of 137 patients were analysed (two withdrew consent, one was excluded); 66 patients in the HVHF group and 71 in the SVHF group. Mortality at 28 days was lower than expected but not different between groups (HVHF 37.9 % vs. SVHF 40.8 %, log-rank test p = 0.94). There were no statistically significant differences in any of the secondary endpoints between treatment groups. Conclusions In the IVOIRE trial, there was no evidence that HVHF at 70 mL/kg/h, when compared with contemporary SVHF at 35 mL/kg/h, leads to a reduction of 28-day mortality or contributes to early improvements in haemodynamic profile or organ function. HVHF, as applied in this trial, cannot be recommended for treatment of septic shock complicated by AKI. |
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