Study characteristics |
Methods |
Study design: parallel RCT
Duration of study: May 1998 to March 2000
Duration of follow‐up: 28 days
|
Participants |
Setting: multicentre (2 centres)
Country: The Netherlands
Patients with circulatory and respiratory insufficiency and early AKI who need CKRT; CrCl < 20 mL/min, and oliguria < 180 mL/6 hours despite fluid resuscitation; circulatory support and furosemide; early timing: < 12 hours inclusion; late timing: BUN > 40 mmol/L or severe pulmonary oedema
Number: intervention group 1 (35); intervention group 2 (35), control group (36)
Mean age ± SD (years): intervention group 1 (68 ± 13); intervention group 2 (70 ± 10); control group (67 ± 13)
Sex (M/F): intervention group 1 (21/14); intervention group 2 (20/15); control group (23/13)
Exclusion criteria: pre‐existing kidney disease with CrCl < 30 mL/min; AKI caused by permanent occlusion or surgical lesion of the renal artery; GN, interstitial nephritis, or vasculitis; postrenal obstruction; CHILD class C liver cirrhosis; AIDS with a CD4 count < 0.05 x 109/L; non‐witnessed arrest with Glasgow Coma Score < 5; haematological malignancy with neutrophils < 0.05 x 109/L; no haemofiltration machine free for use at time of inclusion arrest with Glasgow Coma Score < 5; haematological malignancy with neutrophils < 0.05 x 109/L; no haemofiltration machine free for use at time of inclusion
|
Interventions |
KRT modality
-
CVVHF
Haemofilter: cellulose triacetate hollow‐fibre
Replacement fluid: post‐dilution mode with bicarbonate solution
Anticoagulation: heparin or nadroparin
Intervention group 1
Intervention group 2
Control group
Co‐interventions
|
Outcomes |
Primary outcomes
Secondary outcomes
|
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 using computer‐generated method |
Allocation concealment (selection bias) |
Low risk |
Treatment assignments were kept in numbered, sealed opaque envelopes that were opened 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 |
Unclear risk |
Insufficient information to permit judgement |