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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

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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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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.

Author information

Authors and Affiliations

  1. Service d’Anesthésie-Réanimation 2, Centre Hospitalier Universitaire (CHU) de Bordeaux, 33000, Bordeaux, France

    Olivier Joannes-Boyau, Antoine Dewitte, Catherine Fleureau, Olivier Branchard, Hadrien Rozé, Joachim Calderon, Gérard Janvier & Alexandre Ouattara

  2. Universitair Ziekenhuis Brussel, Vrije Universitieit Brussel (VUB), Brussels, Belgium

    Patrick M. Honoré, Rita Jacobs & Herbert D. Spapen

  3. Unité de Soutien Méthodologique à la Recherche Clinique et Épidémiologique (USMR), Pôle de Santé Publique et CIC-EC7, Centre Hospitalier Universitaire (CHU) de Bordeaux, 33000, Bordeaux, France

    Paul Perez & Anne-Sophie Grandoulier

  4. Division of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta, Edmonton, AB, T6G 2B7, Canada

    Sean M. Bagshaw

  5. Réanimation Polyvalente, Pôle EPURS, Hopital R. BOULIN, 33500, Libourne, France

    Hubert Grand & Bernard Gauche

  6. Department of General Intensive Care, University Hospital of Liege, Domaine Universitaire de Liège, Liege, Belgium

    Jean-Luc Canivet

  7. Service d’Anesthésie et Réanimation, Hôpital Cardiovasculaire et Pneumologique Louis Pradel, Lyon, France

    Claire Flamens

  8. Service de Réanimation, Clinique Bordeaux Nord Aquitaine, 33000, Bordeaux, France

    Wilfried Pujol

  9. Department of Anesthesiology and Critical Care, Albert Michallon Hospital, 38043, Grenoble, France

    Christophe Broux

  10. Réanimation Chirurgicale, Hôpital de Cavale Blanche, CHU de Brest, 29609, Brest, France

    Hervé Floch

  11. Department of Critical Care, Hôpital Tivoli, Université Libre de Bruxelles, La Louvière, Belgium

    Stephane Franck

  12. Cliniques de l’Europe-Site St Michel, Brussels, Belgium

    Vincent Collin

  13. Department of Anesthesiology and Critical Care Medicine, Ziekenhuis Oost-Limburg, Genk, Belgium

    Willem Boer

  14. Univ. Bordeaux, Adaptation Cardiovasculaire à l’ischémie, U1034, 33600, Pessac, France

    Gérard Janvier & Alexandre Ouattara

  15. Haut-Lévèque Hospital, MHL, 3ème étage, 1, Avenue de Magellan, 33600, Pessac, France

    Olivier Joannes-Boyau

Authors
  1. Olivier Joannes-Boyau
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  2. Patrick M. Honoré
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  3. Paul Perez
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  4. Sean M. Bagshaw
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  5. Hubert Grand
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  6. Jean-Luc Canivet
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  7. Antoine Dewitte
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  8. Claire Flamens
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  9. Wilfried Pujol
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  10. Anne-Sophie Grandoulier
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  11. Catherine Fleureau
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  12. Rita Jacobs
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  14. Hervé Floch
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  15. Olivier Branchard
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  16. Stephane Franck
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  17. Hadrien Rozé
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  18. Vincent Collin
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  19. Willem Boer
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  20. Joachim Calderon
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  21. Bernard Gauche
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  23. Gérard Janvier
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  24. Alexandre Ouattara
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Corresponding author

Correspondence to Olivier Joannes-Boyau.

Additional information

On behalf of the IVOIRE Study Group.

Trial registration: ClinicalTrials.gov; Identifier: NCT00241228.

Electronic supplementary material

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Supplementary material 1 (DOCX 54 kb)

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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