Trial Endpoints

Primary Endpoint

  • Our co-primary outcomes will be the occurrence rate of AKI and the maximum severity of AKI within 7 days of ICU admission.

Secondary Endpoints

  • Proportion of patients with AKI among patients without known baseline serum creatinine.
  • Duration of AKI episodes (within first week of ICU admission).
  • Proportion of AKI with rapid reversal (duration < 48 hours) vs persistent AKI (duration ≥ 48 hours).
  • Incidence of acute kidney disease (AKD) at ICU discharge and hospital discharge, truncated at 90-days.
  • Use of RRT within 7 days of ICU admission.
  • Type and specifics of applied RRT (indications, timing, modality, dose anticoagulation, duration, discontinuation).
  • Length of stay in the ICU, post ICU in the hospital, and total length of stay in the hospital.
  • ICU readmission up to day 90.
  • Hospital readmission up to day 90.
  • Serum creatinine level at ICU and hospital discharge (truncated at day 90).
  • RRT dependence at hospital discharge (any RRT applied within 72 hours of discharge).
  • Mortality at hospital discharge (truncated at 90-days).
  • Magnitude of AKI: area under the curve of AKI of severity over time.
  • Incidence of AKI and maximum AKI severity stage defined by serum creatinine and/or urine output criteria only, within 7 days of ICU admission.

Tertiary Endpoints

In addition, for patients included in the "long term outcomes sub-study” (see below), the following additional secondary outcomes will be considered:

  • Serum creatinine level at day 90, and 1 year.
  • RRT dependence at day 90, and 1 year.
  • Mortality at hospital discharge at day 90, and 1 year.
  • Survival analysis up to day 90 and 1 year.
  • Quality of life at day 90 and 1y (EQ-5D).
  • Major Adverse Kidney Events (MAKE): a composite endpoint of death, use of RRT and decreased kidney function at day 90, and 1 year.