Study characteristics |
Methods |
Study design: parallel, open‐label RCT
Duration of study: May 2012 to November 2013
Duration of follow‐up: 90 days
|
Participants |
Setting: multicentre (12 ICUs)
Country: Canada
Critically ill patients with severe AKI defined by the presence of 2 of the following 3 criteria: a 2‐fold increase in SCr from baseline, urine output < 6 mL/kg in the preceding 12 hours; whole‐blood NGAL ≥ 400 ng/mL; absence of urgent indications for KRT initiation (defined as serum potassium ≤ 5.5 mmol/L and serum bicarbonate ≥ 15 mmol/L); low likelihood of volume‐responsive AKI; defined as central venous pressure ≥ 8 mm Hg
Number: intervention group (48); control group (52)
Mean age ± SD (years): intervention group (62.2 ± 11.9); control group (63.9 ± 13.6)
Sex (M/F): intervention group (35/13); control group (37/15)
Exclusion criteria: lack of commitment to ongoing life support, including KRT; presence of an intoxication requiring extracorporeal removal; KRT within the previous 2 months; clinical suspicion of renal obstruction, rapidly progressive GN, or interstitial nephritis; pre‐hospitalisation eGFR < 30 mL/min/1.73 m²; the passage of > 48 hours since doubling of baseline SCr; clinician(s) caring for patient believes that immediate KRT is absolutely mandated; clinician(s) caring for patient believes that deferral of KRT initiation is mandated; patient or substitute decision maker is unable to provide consent within 12 hours of determination of study eligibility
|
Interventions |
KRT modality
Intervention group
Control group
Co‐interventions
|
Outcomes |
Death in ICU
Death in hospital
Death by day 90
Alive and dialysis‐dependent at day 90
Duration of ICU stay among survivors
Duration of hospitalisation among survivors
Adverse events
|
Notes |
|
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Low risk |
Patients randomly assigned to one of two treatments using computer‐generated method |
Allocation concealment (selection bias) |
Low risk |
Treatment assignments were kept in numbered, sealed opaque envelopes that were opened in numeric sequence at the time of enrolment |
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 |
Quote: "Alere provided the triage MeterPro that was used to measure whole‐blood NGAL The founders have no influence on the design, analysis and interpretation of the results." |