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. 2022 Nov 23;2022(11):CD010612. doi: 10.1002/14651858.CD010612.pub3

STARRT‐AKI Pilot 2013.

Study characteristics
Methods
  • Study design: parallel, open‐label RCT

  • Duration of study: May 2012 to November 2013

  • Duration of follow‐up: 90 days

Participants
  • Setting: multicentre (12 ICUs)

  • Country: Canada

  • Critically ill patients with severe AKI defined by the presence of 2 of the following 3 criteria: a 2‐fold increase in SCr from baseline, urine output < 6 mL/kg in the preceding 12 hours; whole‐blood NGAL ≥ 400 ng/mL; absence of urgent indications for KRT initiation (defined as serum potassium ≤ 5.5 mmol/L and serum bicarbonate ≥ 15 mmol/L); low likelihood of volume‐responsive AKI; defined as central venous pressure ≥ 8 mm Hg

  • Number: intervention group (48); control group (52)

  • Mean age ± SD (years): intervention group (62.2 ± 11.9); control group (63.9 ± 13.6)

  • Sex (M/F): intervention group (35/13); control group (37/15)

  • Exclusion criteria: lack of commitment to ongoing life support, including KRT; presence of an intoxication requiring extracorporeal removal; KRT within the previous 2 months; clinical suspicion of renal obstruction, rapidly progressive GN, or interstitial nephritis; pre‐hospitalisation eGFR < 30 mL/min/1.73 m²; the passage of > 48 hours since doubling of baseline SCr; clinician(s) caring for patient believes that immediate KRT is absolutely mandated; clinician(s) caring for patient believes 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
  • CVVH, IHD, or both


Intervention group
  • Accelerated KRT initiation: start of KRT within 12 hours of the patient fulfilling study eligibility


Control group
  • Standard KRT initiation: start of KRT when one of the following conditions develop:

    • Serum potassium ≥ 6.0 mmol/L

    • Serum bicarbonate ≤ 10 mmol/L

    • PaO2/FiO2 < 200 with infiltrates on chest radiograph compatible with pulmonary oedema

    • AKI persisted for 72 hours


Co‐interventions
  • Not reported

Outcomes
  • Death in ICU

  • Death in hospital

  • Death by day 90

  • Alive and dialysis‐dependent at day 90

  • Duration of ICU stay among survivors

  • Duration of hospitalisation among survivors

  • Adverse events

Notes
  • Founding source: this study was funded by the Canadian Institutes of Health Research and the University of Alberta Hospital Foundation.

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Patients randomly assigned to one of two treatments using computer‐generated method
Allocation concealment (selection bias) Low risk Treatment assignments were kept in numbered, sealed opaque envelopes that were opened in numeric sequence 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 Low risk Quote: "Alere provided the triage MeterPro that was used to measure whole‐blood NGAL The founders have no influence on the design, analysis and interpretation of the results."