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

Chronic Kidney Disease Clinical Trial

— FUSION  

Official title:

Nephrologist Follow-up Versus Usual Care After an Acute Kidney Injury Hospitalization (FUSION): Vanguard Phase of a Randomized Controlled Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02483039
• Other study ID #: 004
• Status: Active, not recruiting
• Phase: N/A
• First received: June 18, 2015
• Last updated: April 17, 2018
• Start date: September 2015
• Est. completion date: December 2022

Study information

• Verified date: April 2018
• Source: St. Michael's Hospital, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: December 2022
• Est. primary completion date: July 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Acute Kidney Injury
• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic
• Wounds and Injuries

Intervention

Behavioral:
• 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. 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.

Locations

Country	Name	City	State
Canada	Mount Sinai Hospital	Toronto	Ontario
Canada	St. Michael's Hospital	Toronto	Ontario
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario
Canada	University Health Network	Toronto	Ontario

Sponsors (4)

Lead Sponsor	Collaborator
St. Michael's Hospital, Toronto	Mount Sinai Hospital, Canada, Sunnybrook Health Sciences Centre, University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion with a major adverse kidney event	Composite of chronic dialysis, chronic kidney disease progression, or death	1 year after randomization
Secondary	Proportion with a major adverse kidney event	Composite of chronic dialysis, chronic kidney disease progression, or death	30, 90, 365 days, and 5 years following randomization
Secondary	Proportion deceased		30, 90, 365 days, and 5 years following randomization
Secondary	Proportion who require chronic dialysis	one outpatient dialysis treatment at any time after randomization	30, 90, 365 days, and 5 years following randomization
Secondary	Proportion with chronic kidney disease progression using CKD-EPI eGFR equation		30, 90, 365 days, and 5 years following randomization
Secondary	Time to major adverse kidney event	Composite of chronic dialysis, chronic kidney disease progression, or death	5 years following randomization
Secondary	Time to death		5 years following randomization
Secondary	Time to chronic dialysis	one outpatient dialysis treatment at any time after randomization	5 years following randomization
Secondary	Time to CKD progression using CKD-EPI eGFR equation		5 years following randomization
Secondary	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	30, 90, 365 days, and 5 years following randomization
Secondary	Proportion who experience a stroke	Hospitalization or emergency department visit for stroke	30, 90, 365 days, and 5 years following randomization
Secondary	Proportion who experience a congestive heart failure episode	Hospitalization or emergency department visit for congestive heart failure	30, 90, 365 days, and 5 years following randomization
Secondary	Proportion who undergo a cardiac revascularization procedure	Hospitalization or emergency department visit for a cardiac revascularization procedure	30, 90, 365 days, and 5 years following randomization
Secondary	Proportion who experience a myocardial infarction	Hospitalization or emergency department visit for myocardial infarction	30, 90, 365 days, and 5 years following randomization
Secondary	Time to first rehospitalization	Defined as the first readmission to hospital for any reason	5 years following randomization
Secondary	Time to first emergency department visit	Defined as the first emergency department visit for any reason	5 years post-randomization
Secondary	Time to first acute kidney injury episode post-randomization using KDIGO serum creatinine criteria		5 years post-randomization
Secondary	Number of acute kidney injury episodes post-randomization using KDIGO serum creatinine criteria		5 years post-randomization
Secondary	Change in quality-of-life as measured by EuroQol-5D-5L instrument		1 year post-randomization