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

EARLYRRT 2018.

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

  • Duration of study: November 2012 to November 2014

  • Duration of follow‐up: 28 days

Participants
  • Setting: single centre

  • Country: Thailand

  • Critically ill patients ≥ 18 years diagnosed with AKI by RIFLE criteria; high plasma NGAL ≥ 400 ng/mL

  • Number: intervention group (20); control group (20)

  • Mean age ± SD (years): 66.8 ±15.9 years

  • Sex (M/F): 22/18

  • Exclusion criteria: life expectancy < 24 hours; kidney failure; SCr > 2 mg/dL in males or > 1.5 mg/dL in females; previous kidney transplantation and pregnancy

Interventions KRT modality
  • CKRT


Intervention group
  • Early‐strategy group: CKRT was started within 12 hours after randomisation


Control group
  • Standard‐strategy group: CKRT was started when the patients fulfilled the following criteria:

    • Severe metabolic acidosis (pH < 7.20)

    • Hyperkalaemia (> 6.2 mmol/L)

    • Severe pulmonary oedema refractory to diuretics

    • Persistent oliguria or anuria and urea > 40 mg/dL

Outcomes Primary outcomes
  • Death at day 28


Secondary outcomes on day 28 after randomisation
  • Ventilator‐free days

  • ICU‐free days

  • Dialysis‐dependent

  • Fluid balance

  • Recovery of kidney function

  • Adverse events (KRT‐related complications).

Notes
  • Funding source: financial support was provided by Ratchadapiseksomphot endowment fund, Faculty of Medicine, King Chulalongkorn University

  • The study was facilitated by Excellence Center for critical Care Nephrology, King Chulalongkorn Memorial Hospital

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Randomisation with sequentially numbered containers into two groups, using computer‐generated method
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 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 pNGAL kits for use in this study. The company had no influence on the study design or analysis or on the content of this article."