Understanding the natural history of major adverse kidney events after cardiac surgery in patients with chronic kidney disease in Canada
Summary
Client: IQVIA Solutions Canada Inc
Project ID: P2024-205 / 2025 0970 395 000
Research Question/Objectives: The purpose of this study is to assess the incidence of Major Adverse Kidney Events (MAKE), CSA-AKI, and End Stage Renal Disease (ESRD), as well as to estimate the proportion of patients with recovered versus non-recovered kidney injury, and to describe the healthcare resource utilization (HCRU), direct healthcare costs, demographic and clinical characteristics, including risk factors of CSA-AKI, in patients with Chronic Kidney Disease (CKD) who underwent CPB in Canada. Demographic and clinical characteristics of patients that achieved specific outcomes will also be described.
Objectives:
Primary objectives:
- Estimate the incidence of MAKE in patients with CKD within the first 90 days after a CPB surgery by AKI severity and pre-op eGFR and albuminuria categories
- Estimate the incidence of CSA-AKI in patients with CKD within the first 7 days after a CPB surgery by AKI severity and pre-op eGFR and albuminuria categories
- Estimate the incidence of ESRD in patients with CKD within the first 5 years after a CPB surgery by AKI severity† and pre-op eGFR and albuminuria categories
- Estimate the proportion of CKD patients with recovered or non-recovered kidney injury after a CPB surgery by AKI severity† and pre-op eGFR and albuminuria categories.
Secondary objectives:
- Estimate the incidence of KRT, mortality, and the composite of KRT and mortality in CKD patients following CPB by post-op time.
- Describe the demographic and clinical characteristics of CKD patients with MAKE within the first 90 days after a CPB surgery by pre-op eGFR category.
- Describe the demographic and clinical characteristics of CKD patients with recovered or non-recovered kidney injury up to 90 days after a CPB surgery.
- Describe the annual HCRU and direct healthcare costs incurred by CKD patients up to 5 years after a CPB surgery by AKI severity, pre-op eGFR and post-op eGFR categories.
- Compare the annual HCRU and direct healthcare costs incurred by CKD patients who developed CSA-AKI up to 5 years after a CPB surgery to matched controls who did not develop CSA-AKI.
Exploratory objectives:
- Describe the use of drugs by CKD patients that may modulate kidney function before and after a CPB surgery.
- If feasible, estimate the frequency of CKD patients by at-risk category for post-surgical AKI, stratified by the development of CSA-AKI, MAKE, the initiation of KRT, and mortality.
- If feasible, describe the frequency of CKD patients by risk factor for CSA-AKI, stratified by pre-op eGFR and the development of CSA-AKI, MAKE, the initiation of KRT, and mortality.
- If feasible, estimate the frequency of shingles, meningococcal, pneumococcal, and influenza vaccination administered within 15 months or all-time history, as appropriate, before a CPB surgery.
5. Compare clinical outcomes of CKD patients who developed CSA-AKI to matched controls who did not develop CSA-AKI
Status: In Progress