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
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Interventions |
KRT modality
Intervention group
Control group
|
Outcomes |
Primary outcome
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
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Notes |
|
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) |