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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02483039
• Date of registration: 18/06/2015
• Prospective Registration: Yes
• Primary sponsor: St. Michael's Hospital, Toronto
• Public title: Nephrologist Follow-up Versus Usual Care After an Acute Kidney Injury Hospitalization FUSION
• Scientific title: Nephrologist Follow-up Versus Usual Care After an Acute Kidney Injury Hospitalization (FUSION): Vanguard Phase of a Randomized Controlled Trial
• Date of first enrolment: September 2015
• Target sample size: 200
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/show/NCT02483039
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Canada

Contacts

• Name: Ron Wald, MDCM, MPH
• Affiliation: St. Michael's Hospital, Toronto

Key inclusion & exclusion 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)



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Chronic Kidney Disease

Acute Kidney Injury

Intervention(s)

Behavioral: AKI Follow-up Clinic

Primary Outcome(s)

Proportion with a major adverse kidney event [Time Frame: 1 year after randomization]

Secondary Outcome(s)

Time to CKD progression using CKD-EPI eGFR equation [Time Frame: 5 years following randomization]

Time to death [Time Frame: 5 years following randomization]

Proportion deceased [Time Frame: 30, 90, 365 days, and 5 years following randomization]

Proportion with a major adverse kidney event [Time Frame: 30, 90, 365 days, and 5 years following randomization]

Change in quality-of-life as measured by EuroQol-5D-5L instrument [Time Frame: 1 year post-randomization]

Proportion who experience a congestive heart failure episode [Time Frame: 30, 90, 365 days, and 5 years following randomization]

Time to first acute kidney injury episode post-randomization using KDIGO serum creatinine criteria [Time Frame: 5 years post-randomization]

Proportion with chronic kidney disease progression using CKD-EPI eGFR equation [Time Frame: 30, 90, 365 days, and 5 years following randomization]

Proportion who experience a myocardial infarction [Time Frame: 30, 90, 365 days, and 5 years following randomization]

Proportion who undergo a cardiac revascularization procedure [Time Frame: 30, 90, 365 days, and 5 years following randomization]

Time to first rehospitalization [Time Frame: 5 years following randomization]

Time to major adverse kidney event [Time Frame: 5 years following randomization]

Proportion who experience a stroke [Time Frame: 30, 90, 365 days, and 5 years following randomization]

Proportion who require chronic dialysis [Time Frame: 30, 90, 365 days, and 5 years following randomization]

Proportion with a major adverse cardiac event [Time Frame: 30, 90, 365 days, and 5 years following randomization]

Time to first emergency department visit [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]

Time to chronic dialysis [Time Frame: 5 years following randomization]

Secondary ID(s)

004

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Mount Sinai Hospital, Canada

University Health Network, Toronto

Sunnybrook Health Sciences Centre