Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02483039
Recruitment Status : Active, not recruiting
First Posted : June 26, 2015
Last Update Posted : April 19, 2018
Sponsor:
Collaborators:
Sunnybrook Health Sciences Centre
University Health Network, Toronto
Mount Sinai Hospital, Canada
Information provided by (Responsible Party):
Unity Health Toronto

Tracking Information
First Submitted Date  ICMJE June 18, 2015
First Posted Date  ICMJE June 26, 2015
Last Update Posted Date April 19, 2018
Study Start Date  ICMJE September 2015
Estimated Primary Completion Date July 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 25, 2015)
Proportion with a major adverse kidney event [ Time Frame: 1 year after randomization ]
Composite of chronic dialysis, chronic kidney disease progression, or death
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 25, 2015)
  • Proportion with a major adverse kidney event [ Time Frame: 30, 90, 365 days, and 5 years following randomization ]
    Composite of chronic dialysis, chronic kidney disease progression, or death
  • Proportion deceased [ 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 ]
    one outpatient dialysis treatment at any time after 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 [ Time Frame: 5 years following randomization ]
    Composite of chronic dialysis, chronic kidney disease progression, or death
  • Time to death [ Time Frame: 5 years following randomization ]
  • Time to chronic dialysis [ Time Frame: 5 years following randomization ]
    one outpatient dialysis treatment at any time after randomization
  • Time to CKD progression using CKD-EPI eGFR equation [ Time Frame: 5 years following randomization ]
  • Proportion with a major adverse cardiac event [ Time Frame: 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 stroke [ Time Frame: 30, 90, 365 days, and 5 years following randomization ]
    Hospitalization or emergency department visit for stroke
  • Proportion who experience a congestive heart failure episode [ Time Frame: 30, 90, 365 days, and 5 years following randomization ]
    Hospitalization or emergency department visit for congestive heart failure
  • Proportion who undergo a cardiac revascularization procedure [ Time Frame: 30, 90, 365 days, and 5 years following randomization ]
    Hospitalization or emergency department visit for a cardiac revascularization procedure
  • Proportion who experience a myocardial infarction [ Time Frame: 30, 90, 365 days, and 5 years following randomization ]
    Hospitalization or emergency department visit for myocardial infarction
  • Time to first rehospitalization [ Time Frame: 5 years following randomization ]
    Defined as the first readmission to hospital for any reason
  • Time to first emergency department visit [ Time Frame: 5 years post-randomization ]
    Defined as the first emergency department visit for any reason
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Nephrologist Follow-up Versus Usual Care After an Acute Kidney Injury Hospitalization
Official Title  ICMJE Nephrologist Follow-up Versus Usual Care After an Acute Kidney Injury Hospitalization (FUSION): Vanguard Phase of a Randomized Controlled Trial
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Acute Kidney Injury
  • Chronic Kidney Disease
Intervention  ICMJE 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.
Study Arms  ICMJE
  • Experimental: 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
    Intervention: Behavioral: AKI Follow-up Clinic
  • No Intervention: Usual Care
    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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: June 25, 2015)
200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2022
Estimated Primary Completion Date July 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02483039
Other Study ID Numbers  ICMJE 004
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Unity Health Toronto
Study Sponsor  ICMJE Unity Health Toronto
Collaborators  ICMJE
  • Sunnybrook Health Sciences Centre
  • University Health Network, Toronto
  • Mount Sinai Hospital, Canada
Investigators  ICMJE
Principal Investigator: Ron Wald, MDCM, MPH Unity Health Toronto
PRS Account Unity Health Toronto
Verification Date April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP