An interventional study of AKI Follow-up Clinic in Acute Kidney Injury and Chronic Kidney Disease, sponsored by Unity Health Toronto. Status unknown at 4 sites in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-04-19.
Sponsored by Unity Health Toronto · Not applicable, Interventional, and Treatment
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.
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.
3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.
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Exclusion Criteria:
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. The target appointment date is within 30 days of hospital discharge. Routine laboratory investigations will be performed at minimum every three months. Additional in-person visits with a nephrologist at the AKI Follow-up Clinic will be determined at the local sites based upon the participant's clinical status. If in-person visits at 12, 24, and/or 36 weeks are not necessary given the patient's clinical status, they may be replaced with a telephone visit
Behavioral: AKI Follow-up Clinic
Participants randomized to this arm will have a letter outlining their AKI diagnosis mailed to their family physician. Participants may still be referred to a nephrologist by their inpatient or outpatient healthcare provider, but these participants will not have access to the AKI Follow-up Clinic. Rather, they will proceed through the standard local nephrology referral pathway. In addition, all usual care participants will be contacted via telephone by study staff every three months to assess their clinical condition and ensure study engagement. All usual care participants will be offered a nephrologist assessment and/or bloodwork one year after randomization to determine if ongoing nephrology care is indicated based upon the same criteria applied to AKI Follow-up Clinic participants.
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.
Proportion with a major adverse kidney event
Composite of chronic dialysis, chronic kidney disease progression, or death
Time frame: 1 year after randomization
Proportion with a major adverse kidney event
Composite of chronic dialysis, chronic kidney disease progression, or death
Time frame: 30, 90, 365 days, and 5 years following randomization
Proportion deceased
Time frame: 30, 90, 365 days, and 5 years following randomization
Proportion who require chronic dialysis
one outpatient dialysis treatment at any time after randomization
Time frame: 30, 90, 365 days, and 5 years following randomization
Proportion with chronic kidney disease progression using CKD-EPI eGFR equation
Time frame: 30, 90, 365 days, and 5 years following randomization
Time to major adverse kidney event
Composite of chronic dialysis, chronic kidney disease progression, or death
Time frame: 5 years following randomization
Time to death
Time frame: 5 years following randomization
Time to chronic dialysis
one outpatient dialysis treatment at any time after randomization
Time frame: 5 years following randomization
Time to CKD progression using CKD-EPI eGFR equation
Time frame: 5 years following randomization
Proportion with a major adverse cardiac event
Defined as a hospitalization or emergency department visit for stroke, congestive heart failure, myocardial infarction, or cardiac revascularization procedure
Time frame: 30, 90, 365 days, and 5 years following randomization
Proportion who experience a stroke
Hospitalization or emergency department visit for stroke
Time frame: 30, 90, 365 days, and 5 years following randomization
Proportion who experience a congestive heart failure episode
Hospitalization or emergency department visit for congestive heart failure
Time frame: 30, 90, 365 days, and 5 years following randomization
Proportion who undergo a cardiac revascularization procedure
Hospitalization or emergency department visit for a cardiac revascularization procedure
Time frame: 30, 90, 365 days, and 5 years following randomization
Proportion who experience a myocardial infarction
Hospitalization or emergency department visit for myocardial infarction
Time frame: 30, 90, 365 days, and 5 years following randomization
Time to first rehospitalization
Defined as the first readmission to hospital for any reason
Time frame: 5 years following randomization
Time to first emergency department visit
Defined as the first emergency department visit for any reason
Time frame: 5 years post-randomization
Time to first acute kidney injury episode post-randomization using KDIGO serum creatinine criteria
Time frame: 5 years post-randomization
Number of acute kidney injury episodes post-randomization using KDIGO serum creatinine criteria
Time frame: 5 years post-randomization
Change in quality-of-life as measured by EuroQol-5D-5L instrument
Time frame: 1 year post-randomization
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