High-volume versus standard-volume haemofiltration for septic shock patients with acute kidney injury (IVOIRE study): a multicentre randomized controlled trial
- 5k Downloads
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.
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.
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.
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.
KeywordsAcute kidney injury Renal replacement therapy High volume hemofiltration Blood purification Septic shock
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.
- 32.Bellomo R, Ronco C, Kellum JA et al (2004) Acute renal failure—definition, outcome measures, animal models, fluid therapy and information technology needs: the Second International Consensus Conference of the Acute Dialysis Quality Initiative (ADQI) Group. Crit Care 8:R204–R212PubMedCrossRefGoogle Scholar
- 34.Vincent JL, Moreno R, Takala J et al (1996) The SOFA (Sepsis-Related Organ Failure Assessment) score to describe organ dysfunction/failure. On behalf of the Working Group on Sepsis-Related Problems of the European Society of Intensive Care Medicine. Intensive Care Med 22:707–710PubMedCrossRefGoogle Scholar
- 44.Pocock S (1996) Clinical trials: a practical approach. Wiley, CanadaGoogle Scholar