Study characteristics |
Methods |
Study design: prospective, open‐label RCT
Duration of study: March 2016 to July 2017
Duration of follow‐up: 28 days
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Participants |
Setting: multicentre (5 ICUs)
Country: Thailand
Critically ill patients ≥ 18 years with AKI at any stage by KDIGO criteria, FST‐non‐responsive (urine output < 200 mL for the subsequent 2 hours)
Number: intervention group (58); control group (60)
Mean age ± SD (years): intervention group (67.5 ± 15.0); control group (66.7 ± 16.7)
Sex (M/F): intervention group (29/29); control group (29/3)
Exclusion criteria: patients with SCr ≥ 2 mg/dL (male) or ≥ 1.5 mg/dL (female); history of kidney allograft; pregnancy; allergy or known sensitivity to loop diuretics; moribund patients with expected death within 24 hours or whose survival to 28 days was unlikely due to uncontrollable comorbidity; patients with advanced directives who issued the desire not to be resuscitated; prior treatment with KRT within 30 days; serum albumin < 2 g/dL; patients receiving extracorporeal membrane oxygenation or circulatory assistance
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Interventions |
KRT modality
Early KRT group
Standard KRT group
KRT was initiated only if one of the following criteria were met: BUN ≥ 100 mg/dL, serum potassium > 6 mmol/L, serum bicarbonate < 12 mmol/L or pH < 7.15, PaCO2/FIO2 ratio < 200, or chest radiograph compatible with pulmonary oedema
Co‐interventions
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Outcomes |
Primary outcomes
Compliance with the study protocol for > 90% of patients
Ability to use FST to differentiate the KRT rate in FST responders and standard group of nonresponders 50%
Successful randomisation of FST nonresponder
Separation of timing of KRT initiation between the early and standard KRT groups for at least 24 hours
Less than 10% lost to follow‐up
Secondary outcomes
Death at day 28
Fluid balance at day 7
ICU‐free days
Mechanical ventilator‐free days
KRT‐free days
Length of ICU stay and hospital stay
Kidney recovery
Dialysis requirement on day 28
Proportion of patients free from KRT on days 0, 3, and 7
Nonrenal SOFA score on days 0, 3, and 7
KRT‐related adverse events
Vascular access‐related adverse events
Exploratory endpoints
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Notes |
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Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Low risk |
Patients were randomly assigned using 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 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 |
Funding sources were reported (not for profit funding) |