Acute Kidney InjuryFUSIONNCT02483039
Nephrologist Follow-up Versus Usual Care After an Acute Kidney Injury Hospitalization
A study testing AKI Follow-up Clinic in people with Acute Kidney Injury and Chronic Kidney Disease, run by Unity Health Toronto at 4 sites in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury, Chronic Kidney Disease
- What is being tested?
- AKI Follow-up Clinic
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 4 sitesCanada
- Study dates
- Sep 2015to Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 yrs
- Kidney Disease Improving Global Outcomes (KDIGO) stage 2 AKI and above (including need for dialysis)
Who cannot join
- 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)
Trial locations and contacts
4 sites in 1 country.
Canada4 sites
Mount Sinai Hospital
Toronto, Ontario
St. Michael's Hospital
Toronto, Ontario
Sunnybrook Health Sciences Centre
Toronto, Ontario
University Health Network
Toronto, Ontario
About this study
Official title: 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.
Read the 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.
- Conditions
- Acute Kidney Injury, Chronic Kidney Disease
- Being tested
- AKI Follow-up Clinic
- Keywords
- Acute kidney injury, Chronic kidney disease, Quality improvement
- Medical subject headings
- Acute Kidney Injury, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AKI Follow-up ClinicBehavioural
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 group | Role | What they receive |
|---|---|---|
| AKI Follow-up Clinic | Experimental | 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 Receives: Behavioral: AKI Follow-up Clinic |
| Usual Care | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Proportion with a major adverse kidney event
Composite of chronic dialysis, chronic kidney disease progression, or death
Measured: 1 year after randomization
Secondary outcomes (18)
Proportion with a major adverse kidney event
Composite of chronic dialysis, chronic kidney disease progression, or death
Measured: 30, 90, 365 days, and 5 years following randomization
Proportion deceased
Measured: 30, 90, 365 days, and 5 years following randomization
Proportion who require chronic dialysis
one outpatient dialysis treatment at any time after randomization
Measured: 30, 90, 365 days, and 5 years following randomization
Proportion with chronic kidney disease progression using CKD-EPI eGFR equation
Measured: 30, 90, 365 days, and 5 years following randomization
Time to major adverse kidney event
Composite of chronic dialysis, chronic kidney disease progression, or death
Measured: 5 years following randomization
Time to death
Measured: 5 years following randomization
Time to chronic dialysis
one outpatient dialysis treatment at any time after randomization
Measured: 5 years following randomization
Time to CKD progression using CKD-EPI eGFR equation
Measured: 5 years following randomization
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
Measured: 30, 90, 365 days, and 5 years following randomization
Proportion who experience a stroke
Hospitalization or emergency department visit for stroke
Measured: 30, 90, 365 days, and 5 years following randomization
Proportion who experience a congestive heart failure episode
Hospitalization or emergency department visit for congestive heart failure
Measured: 30, 90, 365 days, and 5 years following randomization
Proportion who undergo a cardiac revascularization procedure
Hospitalization or emergency department visit for a cardiac revascularization procedure
Measured: 30, 90, 365 days, and 5 years following randomization
Proportion who experience a myocardial infarction
Hospitalization or emergency department visit for myocardial infarction
Measured: 30, 90, 365 days, and 5 years following randomization
Time to first rehospitalization
Defined as the first readmission to hospital for any reason
Measured: 5 years following randomization
Time to first emergency department visit
Defined as the first emergency department visit for any reason
Measured: 5 years post-randomization
Time to first acute kidney injury episode post-randomization using KDIGO serum creatinine criteria
Measured: 5 years post-randomization
Number of acute kidney injury episodes post-randomization using KDIGO serum creatinine criteria
Measured: 5 years post-randomization
Change in quality-of-life as measured by EuroQol-5D-5L instrument
Measured: 1 year post-randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2015 (estimated)
- Study startSep 2015
- Primary completionJul 2018 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by Unity Health TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Sunnybrook Health Sciences Centre, University Health Network, Toronto, Mount Sinai Hospital, Canada
- Responsible party
- Sponsor
- Investigators
- Ron Wald, MDCM, MPH, Principal investigator, Unity Health Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02483039
- Sponsor's protocol ID
- 004
- Acronym
- FUSION
- Status last verified
- Apr 2018
- First submitted
- 18 Jun 2015
- Last updated
- 19 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Robinson C, Hessey E, Nunes S, Dorais M, Chanchlani R, Lacroix J, Jouvet P, Phan V, Zappitelli M. Acute kidney injury in the pediatric intensive care unit: outpatient follow-up. Pediatr Res. 2022 Jan;91(1):209-217. doi: 10.1038/s41390-021-01414-9. Epub 2021 Mar 17.
PubMed 33731806
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nephrologist Follow-up Versus Usual Care After an Acute Kidney Injury Hospitalization (FUSION): Vanguard Phase of a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02483039
- Acronym / sponsor ID
- FUSION / 004
- Conditions
- Acute Kidney Injury, Chronic Kidney Disease
- Keywords
- Acute kidney injury, Chronic kidney disease, Quality improvement
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Collaborators
- Sunnybrook Health Sciences Centre, University Health Network, Toronto, Mount Sinai Hospital, Canada
- Study start
- Sep 2015
- Primary completion
- Jul 2018 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 26 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AKI Follow-up Clinic | Experimental | Behavioral: AKI Follow-up ClinicParticipants 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 |
| Usual Care | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age ≥ 18 yrs
- Kidney Disease Improving Global Outcomes (KDIGO) stage 2 AKI and above (including need for dialysis)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AKI Follow-up ClinicParticipants 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. | Behavioural | AKI Follow-up Clinic |
Primary outcome
Proportion with a major adverse kidney event
Time frame: 1 year after randomization
Composite of chronic dialysis, chronic kidney disease progression, or death
18 secondary outcomes
Proportion with a major adverse kidney event
Time frame: 30, 90, 365 days, and 5 years following randomization
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
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
Time to death
Time frame: 5 years following randomization
Time to chronic dialysis
Time frame: 5 years following 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
Proportion who experience a stroke
Time frame: 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
Proportion who undergo a cardiac revascularization procedure
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
Time to first rehospitalization
Time frame: 5 years following randomization
Time to first emergency department visit
Time frame: 5 years post-randomization
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2018.
- Derived from this study: PubMed 33731806Robinson C, Hessey E, Nunes S, Dorais M, Chanchlani R, Lacroix J, Jouvet P, Phan V, Zappitelli M. Acute kidney injury in the pediatric intensive care unit: outpatient follow-up. Pediatr Res. 2022 Jan;91(1):209-217. doi: 10.1038/s41390-021-01414-9. Epub 2021 Mar 17.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ron Wald, MDCM, MPH principal investigator
Unity Health Toronto
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AKI Follow-up Clinic in people with Acute Kidney Injury and Chronic Kidney Disease, run by Unity Health Toronto at 4 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion with a major adverse kidney event (time frame: 1 year after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02483039, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2018.