title: High-volume versus standard-volume haemofiltration for septic shock patients with acute kidney injury (IVOIRE study): a multicentre randomized controlled trial.
abstract: OBJECTIVE
  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.
authors.affiliation: Service d'Anesthésie-Réanimation 2, Centre Hospitalier Universitaire (CHU) de Bordeaux, 33000, Bordeaux, France. olivier.joannes-boyau@chu-bordeaux.fr
authors.forename: Olivier
authors.initials: O
authors.lastname: Joannes-Boyau
authors.forename: Patrick M
authors.initials: PM
authors.lastname: Honoré
authors.forename: Paul
authors.initials: P
authors.lastname: Perez
authors.forename: Sean M
authors.initials: SM
authors.lastname: Bagshaw
authors.forename: Hubert
authors.initials: H
authors.lastname: Grand
authors.forename: Jean-Luc
authors.initials: JL
authors.lastname: Canivet
authors.forename: Antoine
authors.initials: A
authors.lastname: Dewitte
authors.forename: Claire
authors.initials: C
authors.lastname: Flamens
authors.forename: Wilfried
authors.initials: W
authors.lastname: Pujol
authors.forename: Anne-Sophie
authors.initials: AS
authors.lastname: Grandoulier
authors.forename: Catherine
authors.initials: C
authors.lastname: Fleureau
authors.forename: Rita
authors.initials: R
authors.lastname: Jacobs
authors.forename: Christophe
authors.initials: C
authors.lastname: Broux
authors.forename: Hervé
authors.initials: H
authors.lastname: Floch
authors.forename: Olivier
authors.initials: O
authors.lastname: Branchard
authors.forename: Stephane
authors.initials: S
authors.lastname: Franck
authors.forename: Hadrien
authors.initials: H
authors.lastname: Rozé
authors.forename: Vincent
authors.initials: V
authors.lastname: Collin
authors.forename: Willem
authors.initials: W
authors.lastname: Boer
authors.forename: Joachim
authors.initials: J
authors.lastname: Calderon
authors.forename: Bernard
authors.initials: B
authors.lastname: Gauche
authors.forename: Herbert D
authors.initials: HD
authors.lastname: Spapen
authors.forename: Gérard
authors.initials: G
authors.lastname: Janvier
authors.forename: Alexandre
authors.initials: A
authors.lastname: Ouattara
mesh_terms: D058186:Acute Kidney Injury / Q000150:complications* / Q000401:mortality; D000368:Aged; D016638:Critical Illness; D005260:Female; D006440:Hemofiltration / Q000379:methods*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D012772:Shock, Septic / Q000150:complications* / Q000401:mortality / Q000628:therapy*; D015996:Survival Rate; D013997:Time Factors