Study characteristics |
Methods |
Study design: parallel, open‐label RCT
Duration of study: October 2015 to December 2019
Duration of follow‐up: 90 days
|
Participants |
Setting: multicentre (168 centres)
Country: 15 countries
Critically ill patients ≥ 18 years and AKI (KDIGO stage 2 or 3)
Number: intervention group (1465); control group (1462)
Mean age ± SD (years): intervention group (64.6 ± 14.3); control group (63.7 ± 13.4)
Sex (M/F): intervention group (995/470); control group (995/467)
Exclusion criteria: lack of commitment to ongoing life support, including KRT; presence of an intoxication requiring extracorporeal removal; KRT within the previous 2 months (either acute or chronic KRT); clinical suspicion of renal obstruction, rapidly progressive GN, or acute interstitial nephritis; pre‐hospitalisation eGFR < 20 mL/min/1.73 m²; clinicians caring for patient believes that immediate KRT is absolutely mandated; clinicians caring for patient believe 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 |
Primary outcome
Secondary outcomes
Dialysis‐dependent at day 90
Composite of death or KRT dependence at day 90
Sustained reduction of kidney function (< 75% baseline eGFR) at day 90
Death in ICU at day 28
Death during hospitalisation
Days free of KRT at 90 days
Mechanical ventilation‐free days at day 28
Vasoactive therapy‐free days at day 28
ICU‐free days at day 28
Hospitalisation‐free days at day 28
QoL at day 28 and day 365
Health care costs
Adverse events
Adverse events related to KRT and vascular access
|
Notes |
This study was supported by grants from the Canadian Institutes of Health Research; Baxter Healthcare Corporation, the National Health Medical Research Council of Australia, the Health Research Council of New Zealand, and the Health Technology Assessment Program of the United Kingdom National Institute of Health Research
|
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Low risk |
Patients were randomly 1:1 to accelerated versus standard initiation of KRT with variable block sizes (2 and 4) and stratified by centre using a centralised concealed web‐based randomisation system |
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 unlikely 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: "The funding organizations and partners were not involved in the design, implementation, management, analysis, and interpretation of the results". |