Table 1.
Summary of research projects proposed by the ART panel
| Epidemiology of AKI | Medical therapy of AKI | Continuous renal replacement therapy | |
|---|---|---|---|
| Main research question | What is the epidemiology of critically ill patients with AKI of different durations? | Is a higher target MAP in critically ill patients with pre-existing hypertension renoprotective? | What is the difference in large molecule clearance between convection versus diffusion? |
| Systematic review of literature | AKI prevalence | Role of higher MAP for patients with hypertension at risk of development or progression of AKI | Solute clearance in CVVH vs CVVHD |
| Cohort study | Retrospective cohort | – | International survey |
| RCT | – | ||
| Target group | Hypertensive adult patients admitted to ICU | Patients on CRRT | |
| Intervention group | Target MAP 80–90 mmHg for at least 48 hours after randomization | treatment with CVVH | |
| Comparator | Target MAP 65-75 mmHg for at least 48 hours after randomization | Treatment with CVVHD | |
| Primary outcome |
In patients without AKI at randomization: Primary outcome: prevention of AKI in 7 days In patients with AKI and no need for RRT at randomization: Primary outcome: MAKE at 28 days |
Clearance of beta 2 microglobulin | |
| Sample size calculation |
Hypothesis 1: Expecting 40% of MAKE 30 in patients with AKI in the control group and a 10% absolute decrease in the risk (ie. 30% of MAKE 30 in intervention group) Target: 182 patients per group (alpha risk 5%, power 80%) Target: 240 patients per group (alpha risk 5%, power 90%) Hypothesis 2: Expecting 40% of MAKE 30 in patients with AKI in the control group and a 5% absolute decrease in the risk (ie 35% of MAKE 30 in intervention group) Target: 742 patients per group (alpha risk 5%, power 80%) Target: 988 patients per group (alpha risk 5%, power 90%) |
60 patients per group |
AKI acute kidney injury, ART acute kidney injury round table, CRRT continuous renal replacement therapy, CVVHD continuous veno-venous haemodialysis, CVVH continuous veno-venous haemofiltration, MAKE 30 major adverse kidney events at day 30, MAP mean arterial pressure, RCT randomized controlled trial