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

April 17, 2018 updated by: Unity Health Toronto

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada
        • Mount Sinai Hospital
      • Toronto, Ontario, Canada
        • St. Michael's Hospital
      • Toronto, Ontario, Canada
        • Sunnybrook Health Sciences Centre
      • Toronto, Ontario, Canada
        • University Health Network

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
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.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Proportion with a major adverse kidney event
Time Frame: 1 year after randomization
Composite of chronic dialysis, chronic kidney disease progression, or death
1 year after randomization

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
30, 90, 365 days, and 5 years following randomization
Proportion deceased
Time Frame: 30, 90, 365 days, and 5 years following randomization
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
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
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
5 years following randomization
Time to death
Time Frame: 5 years following randomization
5 years following randomization
Time to chronic dialysis
Time Frame: 5 years following randomization
one outpatient dialysis treatment at any time after randomization
5 years following randomization
Time to CKD progression using CKD-EPI eGFR equation
Time Frame: 5 years following randomization
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
30, 90, 365 days, and 5 years following randomization
Proportion who experience a stroke
Time Frame: 30, 90, 365 days, and 5 years following randomization
Hospitalization or emergency department visit for stroke
30, 90, 365 days, and 5 years following randomization
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
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
Hospitalization or emergency department visit for a cardiac revascularization procedure
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
Hospitalization or emergency department visit for myocardial infarction
30, 90, 365 days, and 5 years following randomization
Time to first rehospitalization
Time Frame: 5 years following randomization
Defined as the first readmission to hospital for any reason
5 years following randomization
Time to first emergency department visit
Time Frame: 5 years post-randomization
Defined as the first emergency department visit for any reason
5 years post-randomization
Time to first acute kidney injury episode post-randomization using KDIGO serum creatinine criteria
Time Frame: 5 years post-randomization
5 years post-randomization
Number of acute kidney injury episodes post-randomization using KDIGO serum creatinine criteria
Time Frame: 5 years post-randomization
5 years post-randomization
Change in quality-of-life as measured by EuroQol-5D-5L instrument
Time Frame: 1 year post-randomization
1 year post-randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Unity Health Toronto

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University Health Network, Toronto
Sunnybrook Health Sciences Centre
Mount Sinai Hospital, Canada

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ron Wald, MDCM, MPH, Unity Health Toronto

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2015

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2018

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 18, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 25, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 26, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 19, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 17, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 004

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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