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.