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

FST 2018.

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

  • Duration of study: March 2016 to July 2017

  • Duration of follow‐up: 28 days

Participants
  • Setting: multicentre (5 ICUs)

  • Country: Thailand

  • Critically ill patients ≥ 18 years with AKI at any stage by KDIGO criteria, FST‐non‐responsive (urine output < 200 mL for the subsequent 2 hours)

  • Number: intervention group (58); control group (60)

  • Mean age ± SD (years): intervention group (67.5 ± 15.0); control group (66.7 ± 16.7)

  • Sex (M/F): intervention group (29/29); control group (29/3)

  • Exclusion criteria: patients with SCr ≥ 2 mg/dL (male) or ≥ 1.5 mg/dL (female); history of kidney allograft; pregnancy; allergy or known sensitivity to loop diuretics; moribund patients with expected death within 24 hours or whose survival to 28 days was unlikely due to uncontrollable comorbidity; patients with advanced directives who issued the desire not to be resuscitated; prior treatment with KRT within 30 days; serum albumin < 2 g/dL; patients receiving extracorporeal membrane oxygenation or circulatory assistance

Interventions KRT modality
  • CVVH PIKRT HD


Early KRT group
  • Initiation of KRT was started within 6 hours of randomisation


Standard KRT group
  • KRT was initiated only if one of the following criteria were met: BUN ≥ 100 mg/dL, serum potassium > 6 mmol/L, serum bicarbonate < 12 mmol/L or pH < 7.15, PaCO2/FIO2 ratio < 200, or chest radiograph compatible with pulmonary oedema


Co‐interventions
  • Not reported

Outcomes Primary outcomes
  • Compliance with the study protocol for > 90% of patients

  • Ability to use FST to differentiate the KRT rate in FST responders and standard group of nonresponders 50%

  • Successful randomisation of FST nonresponder

  • Separation of timing of KRT initiation between the early and standard KRT groups for at least 24 hours

  • Less than 10% lost to follow‐up


Secondary outcomes
  • Death at day 28

  • Fluid balance at day 7

  • ICU‐free days

  • Mechanical ventilator‐free days

  • KRT‐free days

  • Length of ICU stay and hospital stay

  • Kidney recovery

  • Dialysis requirement on day 28

  • Proportion of patients free from KRT on days 0, 3, and 7

  • Nonrenal SOFA score on days 0, 3, and 7

  • KRT‐related adverse events

  • Vascular access‐related adverse events


Exploratory endpoints
  • Biomarkers: plasma NGAL and Ang2, and NT‐proBNP on days 0, 3, and 7

Notes
  • Funding source: supported by the Excellence Center for Critical Care Nephrology, King Chulalongkorn Memorial Hospital, funded by The National Kidney Foundation of Thailand

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Patients were randomly assigned 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 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 Funding sources were reported (not for profit funding)