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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Acknowledgments
A special thanks to the members of the Data Safety and Monitoring Committee (J.P. Pignon, Villejuif; F. Sztark, Bordeaux; G. Boulard, Bordeaux; L. Trinquard, Paris; G. Hanique, Brussels) who helped us to steer the study and gave valuable comments on the manuscript. Thanks to the Hospital Pharmacovigilance Unit which reviews all the serious adverse events for classification. A big thanks to all the participants and in particular the nurses that worked continuously for the success of this study. The study was supported by a grant from the French Health Ministry (Hospital Clinical Research Program—PHRC).
Conflicts of interest
Dr. Bagshaw is supported by a Canada Research Chair in Critical Care Nephrology and Clinical Investigator Award from Alberta Innovates—Health Solutions. Other authors do not have any conflict of interest.
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On behalf of the IVOIRE Study Group.
Trial registration: ClinicalTrials.gov; Identifier: NCT00241228.
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Appendix: Participating centres and investigators
Appendix: Participating centres and investigators
University Hospital of Bordeaux, Hopital Haut-Lévèque (France): Joannes-Boyau, Fleureau, Dewitte, Coquin, Rozé, Janvier, Ouattara; St-Pierre Para-University Hospital (Belgium): Honoré; Hopital R. Boulin, Libourne (France): Grand, Gauche; University Hospital of Liege (Belgium): Canivet, Wiesen, Dubois; Hôpital Cardiovasculaire et Pneumologique Louis Pradel, Lyon (France): Flamens, Bastien; Clinique Bordeaux Nord Aquitaine, Bordeaux (France): Pujol, Perdrix, Clement; Hopital Européen Georges Pompidou (HEGP), Paris (France): Journois; Albert Michallon Hospital, Grenoble (France): Broux, Robin, Durand; Hôpital de Cavale Blanche, CHU de Brest (France): Floch; Hôpital Tivoli, Université Libre de Bruxelles, La Louvière (Belgium): Franck, Bouckaert; Cliniques de l’Europe-Site St Michel, Brussels (Belgium): Collin.
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Joannes-Boyau, O., Honoré, P.M., Perez, P. et al. High-volume versus standard-volume haemofiltration for septic shock patients with acute kidney injury (IVOIRE study): a multicentre randomized controlled trial. Intensive Care Med 39, 1535–1546 (2013). https://doi.org/10.1007/s00134-013-2967-z
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DOI: https://doi.org/10.1007/s00134-013-2967-z