IDEAL‐ICU 2014

Methods	Study design: parallel RCT Study duration: recruitment started in March 2012 and will be completed by March 2015
Participants	Setting: multicentre (24 ICUs) Country: France Patients with severe early septic shock developing AKI with at least one criterion characteristic of the failure stage of the RIFLE classification Number: 864 critically ill adults patients will be enrolled Aged > 18 years; in the first 48 hours of septic shock Exclusion criteria: chronic renal replacement; obstructive AKI; need for emergency RRT before randomisation (hyperkalaemia > 6.5 mmol/L, metabolic acidosis with pH < 7.15 or extravascular fluid overload refractory to diuretics with pulmonary oedema); pregnancy; patient is moribund with expected death within 24 hours; patients for whom survival to 28 days is unlikely due to an uncontrollable comorbidity (cardiac, pulmonary or hepatic end‐stage disease, hepatorenal syndrome, poorly controlled cancer, severe post‐anoxic encephalopathy); patients with advance directives issued expressing the desire not to be resuscitated, patient under tutorship, curatorship or judicial protection
Interventions	Treatment group Early RRT: initiation of RRT immediately after the diagnosis of AKI (maximum of 12 hours) Control group Delayed RRT: initiation of RRT at least 48 hours after the diagnosis of AKI
Outcomes	Primary outcome Death at 90 days in patients with AKI at the failure stage according to the RIFLE criteria Secondary outcome Death at day 28 or 180 and 1 year Number of days free of mechanical ventilation Number of days free of RRT ICU length of stay and hospital length of stay Quality of life at day 90 and 1 year (EQ‐5D questionnaire) Efficacy and safety of the two strategies in terms of: episodes of metabolic disorders, arrhythmia, pulmonary oedema, hypotension, haemorrhage, and RRT dependence at hospital discharge.
Notes

AKI ‐ acute kidney injury; ICU ‐ intensive care unit; RCT ‐ randomised controlled study; RRT ‐ renal replacement therapy