Acute Kidney Injury, Chronic Kidney Disease
Conditions
Keywords
Acute kidney injury, Chronic kidney disease, Quality improvement
Brief summary
The primary objective is to evaluate the impact of an AKI Follow-up Clinic on major adverse kidney events (MAKE) in comparison to hospitalized patients surviving an episode of AKI who are not exposed to the AKI Follow-up Clinic intervention.
Detailed description
Survivors of acute kidney injury (AKI) are at increased risk of chronic kidney disease (CKD) and death, but have inconsistent follow-up care. Our team has developed and tested a model to deliver structured follow-up kidney care (the AKI Follow-up Clinic) that is feasible and sustainable, with standardized assessments based upon clinical practice guidelines that are transferable to any setting. This study will randomize patients with Kidney Disease Improving Global Outcomes (KDIGO) stage 2-3 AKI to the AKI Follow-up Clinic or usual care (control group). The usual care group will have a letter outlining their AKI diagnosis mailed to their family physician; the usual care group may still be referred to a nephrologist by their healthcare provider if desired, but these participants will not have access to the AKI Follow-up Clinic pathways. The primary outcome is development of a major adverse kidney event (MAKE), a composite of death, chronic dialysis, and estimated glomerular filtration rate (eGFR) decline. Outcomes will be ascertained after one year of follow-up, which is when AKI Follow-up Clinic patients are transitioned back to their family doctor or general nephrologist based upon pre-specified graduation criteria. Participants will also be followed using local hospital electronic resources and the Institute for Clinical Evaluative Sciences (ICES) administrative databases in order to assess the long-term impact of early nephrologist follow-up on AKI outcomes.
Interventions
BEHAVIORALAKI Follow-up Clinic
Participants randomized to this arm will be referred to the AKI Follow-up Clinic where they will see a nephrologist who will coordinate follow-up care. At the AKI Follow-up Clinic, assessment forms that were developed during the pilot study at St. Michael's Hospital may be used, but this decision will be left to individual sites. Routine laboratory investigations will be performed at minimum every three months.
Sponsors
Sunnybrook Health Sciences Centre
University Health Network, Toronto
Mount Sinai Hospital, Canada
Unity Health Toronto
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 yrs * Kidney Disease Improving Global Outcomes (KDIGO) stage 2 AKI and above (including need for dialysis)
Exclusion criteria
* Kidney transplant recipients * Outpatient baseline eGFR under 30mL/min/1.73m2 (by CKD-EPI equation); ignore if baseline serum creatinine is unavailable * Patients discharged from hospital with a persistent requirement for renal replacement therapy * Clinical diagnosis or suspicion of: glomerulonephritis, vasculitis with kidney involvement, hemolytic-uremic syndrome, polycystic kidney disease, myeloma cast nephropathy * Pregnancy * Residence at a nursing home facility (rehabilitation and retirement home patients should not be excluded) * Palliation as primary goal of care (defined as life expectancy ≤ six months or followed by a palliative care physician) * Patients with previously established and ongoing nephrology follow-up (defined as ≥ one outpatient appointment with a nephrologist in the previous 12 months)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion with a major adverse kidney event | 1 year after randomization | Composite of chronic dialysis, chronic kidney disease progression, or death |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion with a major adverse cardiac event | 30, 90, 365 days, and 5 years following randomization | Defined as a hospitalization or emergency department visit for stroke, congestive heart failure, myocardial infarction, or cardiac revascularization procedure |
| Proportion with a major adverse kidney event | 30, 90, 365 days, and 5 years following randomization | Composite of chronic dialysis, chronic kidney disease progression, or death |
| Proportion deceased | 30, 90, 365 days, and 5 years following randomization | — |
| Proportion who require chronic dialysis | 30, 90, 365 days, and 5 years following randomization | one outpatient dialysis treatment at any time after randomization |
| Proportion with chronic kidney disease progression using CKD-EPI eGFR equation | 30, 90, 365 days, and 5 years following randomization | — |
| Time to major adverse kidney event | 5 years following randomization | Composite of chronic dialysis, chronic kidney disease progression, or death |
| Time to death | 5 years following randomization | — |
| Time to chronic dialysis | 5 years following randomization | one outpatient dialysis treatment at any time after randomization |
| Proportion who experience a stroke | 30, 90, 365 days, and 5 years following randomization | Hospitalization or emergency department visit for stroke |
| Proportion who experience a congestive heart failure episode | 30, 90, 365 days, and 5 years following randomization | Hospitalization or emergency department visit for congestive heart failure |
| Proportion who undergo a cardiac revascularization procedure | 30, 90, 365 days, and 5 years following randomization | Hospitalization or emergency department visit for a cardiac revascularization procedure |
| Proportion who experience a myocardial infarction | 30, 90, 365 days, and 5 years following randomization | Hospitalization or emergency department visit for myocardial infarction |
| Time to first rehospitalization | 5 years following randomization | Defined as the first readmission to hospital for any reason |
| Time to first emergency department visit | 5 years post-randomization | Defined as the first emergency department visit for any reason |
| Time to first acute kidney injury episode post-randomization using KDIGO serum creatinine criteria | 5 years post-randomization | — |
| Number of acute kidney injury episodes post-randomization using KDIGO serum creatinine criteria | 5 years post-randomization | — |
| Change in quality-of-life as measured by EuroQol-5D-5L instrument | 1 year post-randomization | — |
| Time to CKD progression using CKD-EPI eGFR equation | 5 years following randomization | — |
Countries
Canada
Outcome results
None listed