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High-volume versus standard-volume haemofiltration for septic shock patients with acute kidney injury (IVOIRE study): a multicentre randomized controlled trial
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
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
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.
Keywords:
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