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. 2022 Nov 23;2022(11):CD010612. doi: 10.1002/14651858.CD010612.pub3

IDEAL‐ICU 2014.

Study characteristics
Methods
  • Study design: parallel open‐label RCT

  • Study duration: July 2012 to October 2016

  • Duration of follow‐up: 90 days

Participants
  • Setting: multicentre (22 university teaching hospitals and 7 general hospitals)

  • Country: France

  • Critically ill patients ≥ 18 years with AKI (RIFLE‐F stage) and septic shock

  • Number: intervention group (246); control group (242)

  • Mean age ± SD (years): intervention group (69.3 ± 11.6); control group (68.7 ± 12.8)

  • Sex (M/F): intervention group (142/104); control group (154/88)

  • Exclusion criteria: chronic KRT; obstructive AKI; need for emergency KRT 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 KRT modality
  • Continuous and intermittent


Intervention group
  • Early KRT: initiation of KRT immediately after the diagnosis of AKI‐failure stage (RIFLE classification) maximum of 12 hours


Control group
  • Delayed KRT: KRT was initiated 48 hours after the diagnosis of AKI‐failure stage when the patients fulfilled the following criteria

    • Serum potassium ≥ 6.5 mmol/L

    • pH ≤ 7.15

    • Severe pulmonary oedema refractory to diuretics

    • No kidney function recovery 48 hours after the diagnosis of AKI‐failure stage

Outcomes Primary outcome
  • Death from any cause at day 90 after randomisation


Secondary outcomes
  • Death at 28 days and 180 days

  • Number of days free of KRT at 28 days

  • Number of days free of mechanical ventilation at 28 days

  • Number of days free of vasopressors at 28 days

  • ICU and hospital length of stay

  • QoL at day 90 and 1 year (EQ‐5D questionnaire)

  • Adverse events: episodes of metabolic disorders, arrhythmia, pulmonary oedema, hypotension, haemorrhage

  • KRT dependence at hospital discharge

Notes
  • Founding source: supported by grant from the Programme Hospitalier de Recherchere Clinique National (A00519), funded by the French Ministry of Health

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Patients were randomly assigned to the early or delayed‐strategy group in a 1:1 ratio by means of an online response system (Tenalea software)
Allocation concealment (selection bias) Low risk Central allocation process
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk Insufficient information to permit judgement (for kidney recovery was unclear risk but for death was low risk)
Blinding of outcome assessment (detection bias)
All outcomes Low risk The outcome measurement is not likely to be influenced by lack of blinding
Incomplete outcome data (attrition bias)
All outcomes Low risk Complete outcome data were reported
Selective reporting (reporting bias) Low risk The study reported death, kidney function recovery and adverse events
Other bias Low risk Funding sources were reported (not for profit funding)