Clinical trial NCT02483039: Nephrologist Follow-up Versus Usual Care After an Acute Kidney Injury Hospitalization
Official title: Nephrologist Follow-up Versus Usual Care After an Acute Kidney Injury Hospitalization (FUSION): Vanguard Phase of a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acute Kidney Injury
Chronic Kidney Disease
Keywords: Acute kidney injury
Chronic kidney disease
Quality improvement
Lead sponsor: Unity Health Toronto
Sponsor class: OTHER
Collaborators: name: Sunnybrook Health Sciences Centre
name: University Health Network, Toronto
name: Mount Sinai Hospital, Canada
First posted: 2015-06-26
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Proportion with a major adverse kidney event
timeFrame: 1 year after randomization
Secondary outcomes:
measure: Proportion with a major adverse kidney event
timeFrame: 30, 90, 365 days, and 5 years following randomization
measure: Proportion deceased
timeFrame: 30, 90, 365 days, and 5 years following randomization
measure: Proportion who require chronic dialysis
timeFrame: 30, 90, 365 days, and 5 years following randomization
measure: Proportion with chronic kidney disease progression using CKD-EPI eGFR equation
timeFrame: 30, 90, 365 days, and 5 years following randomization
measure: Time to major adverse kidney event
timeFrame: 5 years following randomization
measure: Time to death
timeFrame: 5 years following randomization
measure: Time to chronic dialysis
timeFrame: 5 years following randomization
measure: Time to CKD progression using CKD-EPI eGFR equation
timeFrame: 5 years following randomization
measure: Proportion with a major adverse cardiac event
timeFrame: 30, 90, 365 days, and 5 years following randomization
measure: Proportion who experience a stroke
timeFrame: 30, 90, 365 days, and 5 years following randomization
measure: Proportion who experience a congestive heart failure episode
timeFrame: 30, 90, 365 days, and 5 years following randomization
measure: Proportion who undergo a cardiac revascularization procedure
timeFrame: 30, 90, 365 days, and 5 years following randomization
measure: Proportion who experience a myocardial infarction
timeFrame: 30, 90, 365 days, and 5 years following randomization
measure: Time to first rehospitalization
timeFrame: 5 years following randomization
measure: Time to first emergency department visit
timeFrame: 5 years post-randomization
measure: Time to first acute kidney injury episode post-randomization using KDIGO serum creatinine criteria
timeFrame: 5 years post-randomization
measure: Number of acute kidney injury episodes post-randomization using KDIGO serum creatinine criteria
timeFrame: 5 years post-randomization
measure: Change in quality-of-life as measured by EuroQol-5D-5L instrument
timeFrame: 1 year post-randomization
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Mount Sinai Hospital
state: Ontario
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: University Health Network
state: Ontario
Study officials:
affiliation: Unity Health Toronto
name: Ron Wald, MDCM, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Robinson C, Hessey E, Nunes S, Dorais M, Chanchlani R, Lacroix J, Jouvet P, Phan V, Zappitelli M. Acute kidney injury in the pediatric intensive care unit: outpatient follow-up. Pediatr Res. 2022 Jan;91(1):209-217. doi: 10.1038/s41390-021-01414-9. Epub 2021 Mar 17.