title: Optimal Mode of clearance in critically ill patients with Acute Kidney Injury (OMAKI)--a pilot randomized controlled trial of hemofiltration versus hemodialysis: a Canadian Critical Care Trials Group project.
abstract: BACKGROUND
  Among critically ill patients with acute kidney injury (AKI) needing continuous renal replacement therapy (CRRT), the effect of convective (via continuous venovenous hemofiltration [CVVH]) versus diffusive (via continuous venovenous hemodialysis [CVVHD]) solute clearance on clinical outcomes is unclear. Our objective was to evaluate the feasibility of comparing these two modes in a randomized trial.
  
  
  METHODS
  This was a multicenter open-label parallel-group pilot randomized trial of CVVH versus CVVHD. Using concealed allocation, we randomized critically ill adults with AKI and hemodynamic instability to CVVH or CVVHD, with a prescribed small solute clearance of 35 mL/kg/hour in both arms. The primary outcome was trial feasibility, defined by randomization of >25% of eligible patients, delivery of >75% of the prescribed CRRT dose, and follow-up of >95% of patients to 60 days. A secondary analysis using a mixed-effects model examined the impact of therapy on illness severity, defined by sequential organ failure assessment (SOFA) score, over the first week.
  
  
  RESULTS
  We randomized 78 patients (mean age 61.5 years; 39% women; 23% with chronic kidney disease; 82% with sepsis). Baseline SOFA scores (mean 15.9, SD 3.2) were similar between groups. We recruited 55% of eligible patients, delivered >80% of the prescribed dose in each arm, and achieved 100% follow-up. SOFA tended to decline more over the first week in CVVH recipients (-0.8, 95% CI -2.1, +0.5) driven by a reduction in vasopressor requirements. Mortality (54% CVVH; 55% CVVHD) and dialysis dependence in survivors (24% CVVH; 19% CVVHD) at 60 days were similar.
  
  
  CONCLUSIONS
  Our results suggest that a large trial comparing CVVH to CVVHD would be feasible. There is a trend toward improved vasopressor requirements among CVVH-treated patients over the first week of treatment.
  
  
  BACKGROUND
  ClinicalTrials.gov: NCT00675818.
authors.forename: Ron
authors.initials: R
authors.lastname: Wald
authors.forename: Jan O
authors.initials: JO
authors.lastname: Friedrich
authors.forename: Sean M
authors.initials: SM
authors.lastname: Bagshaw
authors.forename: Karen E A
authors.initials: KE
authors.lastname: Burns
authors.forename: Amit X
authors.initials: AX
authors.lastname: Garg
authors.forename: Michelle A
authors.initials: MA
authors.lastname: Hladunewich
authors.forename: Andrew A
authors.initials: AA
authors.lastname: House
authors.forename: Stephen
authors.initials: S
authors.lastname: Lapinsky
authors.forename: David
authors.initials: D
authors.lastname: Klein
authors.forename: Neesh I
authors.initials: NI
authors.lastname: Pannu
authors.forename: Karen
authors.initials: K
authors.lastname: Pope
authors.forename: Robert M
authors.initials: RM
authors.lastname: Richardson
authors.forename: Kevin
authors.initials: K
authors.lastname: Thorpe
authors.forename: Neill K J
authors.initials: NK
authors.lastname: Adhikari
mesh_terms: D058186:Acute Kidney Injury / Q000401:mortality / Q000628:therapy*; D002170:Canada / Q000453:epidemiology; D016638:Critical Illness; D005260:Female; D006440:Hemofiltration; D006801:Humans; D007362:Intensive Care Units; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D006435:Renal Dialysis