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

AKIKI 2015.

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

  • Duration of study: September 2013 to January 2016

  • Duration of follow‐up: 60 days

Participants
  • Setting: multicentre (31 centres)

  • Country: France

  • Critically ill patients ≥ 18 years with AKI stage 3 (KDIGO classification) requiring invasive mechanical ventilation, catecholamine infusion (epinephrine or norepinephrine) or both

  • Number: intervention group (311); control group (308)

  • Mean age ± SD (years): intervention group (64.8 ± 14.2); control group (67.4 ±13.4)

  • Sex (M/F): intervention group (209/103); control group (198/110)

  • Exclusion criteria: severe laboratory abnormalities: BUN > 112 mg/dL (40 mmol/L); serum potassium >6 mmol/L or >5.5 mmol/L despite medical treatment; pH < 7.15, PaCO2< 35 mmHg or mixed acidosis (PaCO2 ≥50 mmHg or more without the possibility of increasing alveolar ventilation); acute pulmonary oedema; pre‐existing severe CKD (CrCl < 30 mL/min); AKI caused by urinary tract obstruction or renal vessel obstruction or tumour lysis syndrome or thrombotic microangiopathy or acute glomerulopathy; poisoning by a dialyzable agent; child C liver cirrhosis; cardiac arrest without awakening; moribund state (patient likely to die within 24h); patient having already received KRT and kidney transplant

Interventions KRT modalities
  • IHD, CKRT or both


Intervention group
  • Early‐strategy group: KRT was initiated as soon as possible after randomisation within 6 hours after documentation of KDIGO stage 3


Control group
  • Delayed‐strategy group: KRT was initiated only in case of occurrence of one or more of the following events developed above or if oliguria or anuria lasted for more than 72 hours after randomisation


Co‐interventions
  • Not reported

Outcomes Primary outcomes
  • Death at day 28 and day 60


Secondary outcomes
  • Patients requiring at least a KRT in the "waiting" strategy (%)

  • Mechanical ventilation‐free days

  • Vasopressors‐free days

  • KRT‐free days

  • Length of ICU stay

  • Length of hospital stay

  • Nosocomial infection

  • Adverse events potentially related to the AKI or KRT

  • Dependence on KRT at days 28 and 60

Notes
  • Funding source: supported by a grant from the Programme Hospitalier de Recherchere Clinique National, 2012 (AOM 12456), funded by the French Ministry of Health.

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Patients randomly assigned to one of the two treatment groups by means of a centralized, 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 Funding sources were reported (not for profit funding)