Study characteristics |
Methods |
Study design: parallel, open‐label RCT
Duration of study: September 2013 to January 2016
Duration of follow‐up: 60 days
|
Participants |
Setting: multicentre (31 centres)
Country: France
Critically ill patients ≥ 18 years with AKI stage 3 (KDIGO classification) requiring invasive mechanical ventilation, catecholamine infusion (epinephrine or norepinephrine) or both
Number: intervention group (311); control group (308)
Mean age ± SD (years): intervention group (64.8 ± 14.2); control group (67.4 ±13.4)
Sex (M/F): intervention group (209/103); control group (198/110)
Exclusion criteria: severe laboratory abnormalities: BUN > 112 mg/dL (40 mmol/L); serum potassium >6 mmol/L or >5.5 mmol/L despite medical treatment; pH < 7.15, PaCO2< 35 mmHg or mixed acidosis (PaCO2 ≥50 mmHg or more without the possibility of increasing alveolar ventilation); acute pulmonary oedema; pre‐existing severe CKD (CrCl < 30 mL/min); AKI caused by urinary tract obstruction or renal vessel obstruction or tumour lysis syndrome or thrombotic microangiopathy or acute glomerulopathy; poisoning by a dialyzable agent; child C liver cirrhosis; cardiac arrest without awakening; moribund state (patient likely to die within 24h); patient having already received KRT and kidney transplant
|
Interventions |
KRT modalities
Intervention group
Control group
Co‐interventions
|
Outcomes |
Primary outcomes
Secondary outcomes
Patients requiring at least a KRT in the "waiting" strategy (%)
Mechanical ventilation‐free days
Vasopressors‐free days
KRT‐free days
Length of ICU stay
Length of hospital stay
Nosocomial infection
Adverse events potentially related to the AKI or KRT
Dependence on KRT at days 28 and 60
|
Notes |
|
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Low risk |
Patients randomly assigned to one of the two treatment groups by means of a centralized, computer‐generated method |
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) |