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

STARRT‐AKI 2019.

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

  • Duration of study: October 2015 to December 2019

  • Duration of follow‐up: 90 days

Participants
  • Setting: multicentre (168 centres)

  • Country: 15 countries

  • Critically ill patients ≥ 18 years and AKI (KDIGO stage 2 or 3)

  • Number: intervention group (1465); control group (1462)

  • Mean age ± SD (years): intervention group (64.6 ± 14.3); control group (63.7 ± 13.4)

  • Sex (M/F): intervention group (995/470); control group (995/467)

  • Exclusion criteria: lack of commitment to ongoing life support, including KRT; presence of an intoxication requiring extracorporeal removal; KRT within the previous 2 months (either acute or chronic KRT); clinical suspicion of renal obstruction, rapidly progressive GN, or acute interstitial nephritis; pre‐hospitalisation eGFR < 20 mL/min/1.73 m²; clinicians caring for patient believes that immediate KRT is absolutely mandated; clinicians caring for patient believe 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 ≤ 12 mmol/L

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

    • Volume overload and/or AKI persisted > 72 hours following the time of randomisation


Co‐interventions
  • Not reported

Outcomes Primary outcome
  • Death at day 90


Secondary outcomes
  • Dialysis‐dependent at day 90

  • Composite of death or KRT dependence at day 90

  • Sustained reduction of kidney function (< 75% baseline eGFR) at day 90

  • Death in ICU at day 28

  • Death during hospitalisation

  • Days free of KRT at 90 days

  • Mechanical ventilation‐free days at day 28

  • Vasoactive therapy‐free days at day 28

  • ICU‐free days at day 28

  • Hospitalisation‐free days at day 28

  • QoL at day 28 and day 365

  • Health care costs

  • Adverse events

  • Adverse events related to KRT and vascular access

Notes
  • This study was supported by grants from the Canadian Institutes of Health Research; Baxter Healthcare Corporation, the National Health Medical Research Council of Australia, the Health Research Council of New Zealand, and the Health Technology Assessment Program of the United Kingdom National Institute of Health Research

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Patients were randomly 1:1 to accelerated versus standard initiation of KRT with variable block sizes (2 and 4) and stratified by centre using a centralised concealed web‐based randomisation system
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 Quote: "The funding organizations and partners were not involved in the design, implementation, management, analysis, and interpretation of the results".