Nephrologist Follow-up Versus Usual Care After an Acute Kidney Injury Hospitalization

Not Applicable

• Conditions: Acute Kidney Injury; Chronic Kidney Disease
• Interventions: Behavioral: AKI Follow-up Clinic

• Registration Number: NCT02483039
• Lead Sponsor: Unity Health Toronto

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.

Study Timeline

• Study First Submitted: 2015-06-18
• Study First Submitted QC: 2015-06-25
• Study First Posted: 2015-06-26
• Study Start: 2015-09
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-17
• Last Update Posted: 2018-04-19
• Primary Completion: 2018-07
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Age ≥ 18 yrs
• Kidney Disease Improving Global Outcomes (KDIGO) stage 2 AKI and above (including need for dialysis)

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AKI Follow-up Clinic	AKI 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. 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

Primary Outcome Measures

Name	Time	Method
Proportion with a major adverse kidney event	1 year after randomization	Composite of chronic dialysis, chronic kidney disease progression, or death

Secondary Outcome Measures

Name	Time	Method
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 with chronic kidney disease progression using CKD-EPI eGFR equation	30, 90, 365 days, and 5 years following randomization
Time to death	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 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 who experience a myocardial infarction	30, 90, 365 days, and 5 years following randomization	Hospitalization or emergency department visit for myocardial infarction
Change in quality-of-life as measured by EuroQol-5D-5L instrument	1 year post-randomization
Proportion deceased	30, 90, 365 days, and 5 years following randomization
Time to chronic dialysis	5 years following randomization	one outpatient dialysis treatment at any time after randomization
Time to CKD progression using CKD-EPI eGFR equation	5 years following randomization
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
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
Time to major adverse kidney event	5 years following randomization	Composite of chronic dialysis, chronic kidney disease progression, or death
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 stroke	30, 90, 365 days, and 5 years following randomization	Hospitalization or emergency department visit for stroke
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

Trial Locations

Locations (4)

St. Michael's Hospital; 🇨🇦 Toronto, Ontario, Canada

University Health Network; 🇨🇦 Toronto, Ontario, Canada

Mount Sinai Hospital; 🇨🇦 Toronto, Ontario, Canada

Sunnybrook Health Sciences Centre; 🇨🇦 Toronto, Ontario, Canada