Study characteristics |
Methods |
Publication type: full article
Study design: parallel RCT
Follow‐up period: 90 days
Duration of study: October 2000 to December 2003
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Participants |
Country: Switzerland
Setting: single centre
ICU: yes
Number: treatment group (104); control group (102)
Mean age ± SD (years): treatment group (62 ± 15); control group (65 ± 12)
Sex (M/F): treatment group (57/47); control group (65/37)
Mean severity SD (APACHE 2): treatment group (24 ± 9); control group (26± 9)
Cause of AKI: sepsis (71), other (135)
Inclusion criteria: adults treated in the medical and surgical ICUs of Geneva University Hospital: oliguria (urine output < 200 mL/12 hours) despite fluid resuscitation and intravenous diuretic treatment; and/or azotaemia (BUN > 430 mmol/L) with urine output <1500 mL/12 hours
Exclusion criteria: pre‐kidney failure (reversibility of oliguria/uraemia with fluid administration or with improvement of cardiac output); post‐kidney failure (on kidney ultrasound examination and/or antegrade or retrograde contrast studies if high clinical suspicion); suspicion of glomerular disease (if high clinical suspicion and compatible urinalysis and/or serologic tests); kidney failure with KRT (baseline SCr > 4300 mmol/L or CrCl < 20 mL/min); receiving ACEi (24‐hour temporary exclusion owing to the possibility of ACEi‐induced anaphylactoid reaction with the polyacrylonitrile AN69 filter
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Interventions |
Treatment group
In addition to the ultrafiltration rate, dialysate flow rate was added between 1 and 1.5 L/hour for participants weighing ≤ 70 kg. Owing to the effluent bag capacity, 2.5 L was the maximum hourly ultrafiltration rate if participants were randomised in the CVVHDF group and also received 1.5 L/hour of dialysate
Control group
Ultrafiltration flow rate (1 to 2.5 L/hour) was determined according to participant’s estimated urea distribution volume (60% of their body weight at enrolment), so that this estimated volume could be cleared within 24 hours, for example, an 80 kg subject will have an ultrafiltration flow rate of 2 L/hour. For the purposes of simplification, hourly ultrafiltration flow rate was rounded off to the upper 500 mL level within the interval from 1 to 2.5 L
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Outcomes |
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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 |
QUOTE "...computer‐generated randomization list, in random blocks of four and six participants" |
Allocation concealment (selection bias) |
Low risk |
QUOTE "...corresponding treatment allocation cards were placed in consecutively numbered opaque envelopes. Each time a participant was enrolled in the study, the next available envelope was opened by the nephrologist on call, and the allocated treatment option was communicated to the treatment team" |
Blinding of participants and personnel (performance bias)
All outcomes |
High risk |
Blinding was impossible for "logistic reasons" |
Blinding of outcome assessment (detection bias)
All outcomes |
Low risk |
Outcomes were objective by nature |
Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
There were no drop‐outs |
Selective reporting (reporting bias) |
Unclear risk |
Insufficient information to permit judgement; study protocol was not available |
Other bias: baseline imbalance |
Low risk |
No substantial differences between groups |
Other bias: co‐interventions |
Unclear risk |
Insufficient information to permit judgement |