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. 2021 Sep 14;2021(9):CD013330. doi: 10.1002/14651858.CD013330.pub2

Saudan 2006.

Study characteristics
Methods
  • Publication type: full article

  • Study design: parallel RCT

  • Follow‐up period: 90 days

  • Duration of study: October 2000 to December 2003

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

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

Outcomes
  • Death from any cause at day 28

  • Recovery of kidney function at day 90

Notes
  • Funding source: unclear

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