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Acute Kidney InjuryAFTER AKINCT02915575

Improving Post Discharge Care After Acute Kidney Injury

A study testing Risk guided follow-up in people with Acute Kidney Injury, run by University of Alberta at 2 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this trial is to test the clinical benefit and feasibility of structured risk based post discharge care for hospital acquired Acute kidney injury survivors.This is a Pragmatic randomized controlled trial. It will be conducted at 2 hospitals in Alberta. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Kidney Injury
What is being tested?
Risk guided follow-up
Could I receive a placebo?
No, everyone receives an active treatment
How many people
155 participants
Where
2 sitesCanada
Study dates
19 Mar 2018to 30 Nov 2024
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
  • At least a doubling of serum creatinine during hospitalization (including need for dialysis)
  • Have a primary care physician (PCP)
  • No nephrologist follow up arranged after hospital discharge

Who cannot join

  • Baseline GFR<30ml/min/1.73m2(CKD-EPI) or requiring chronic dialysis on admission
  • Renal transplant recipients
  • Poor prognosis not expected to survive > 6 months
  • Residence at a nursing home facility

Trial locations and contacts

2 sites in 1 country.

Canada2 sites
  • Foothills Hospital

    Calgary, Alberta

  • University of Alberta hospital

    Edmonton, Alberta, T6G 2B7

Other trials in Canada

About this study

Official title: Advancing Community Care and Access to Follow-up After Acute Kidney Injury Hospitalization

The purpose of this trial is to test the clinical benefit and feasibility of structured risk based post discharge care for hospital acquired Acute kidney injury survivors.This is a Pragmatic randomized controlled trial. It will be conducted at 2 hospitals in Alberta. 166 participants will be enrolled in this Randomized controlled trial..

Read the detailed description

Research Objective:

To evaluate the impact of risk based decision support on processes of care for high-risk patients following discharge after hospitalization with Acute Kidney injury.

Experimental Strategy- rationale and considerations:

International guidelines for Chronic Kidney disease diagnosis and management provide a stage-based management approach to reduce the risk of adverse cardiovascular and renal outcomes based on estimated glomerular filtration rate (eGFR) and proteinuria. Identified key quality indicators for CKD care include the use of statins in CKD patients greater than age 50, or with diabetes or cardiovascular disease, use of ACEi (angiotensin-converting enzyme inhibitor) and ARB (angiotensin receptor blocker) in patients with proteinuria and referral to nephrology care with a sustained eGFR <30/ml/min/1.73m2. patients at low risk of CKD can be effectively managed by primary care given appropriate support. Study investigator will evaluate the identification of CKD by providing lab requisitions to all study participants. Those in the medium and high risk groups for CKD based on our risk index will be further guided to either a primary care web-based CKD care pathway which helps Primary care Physicians identify, treat and refer CKD patients using best practices, or nephrology care, respectively. Transitional care interventions have been shown to be effective preventing readmission in chronic conditions such as heart failure. Specialist care delivery often through multidisciplinary clinics has been found to improve prescription of proven efficacious medications and outcomes in a number of chronic disease settings including heart failure, Myocardial infarction,asthma and CKD. As there is no specific intervention for treating Acute kidney injury ensuring high adherence to CKD care in affected individuals is a feasible, sustainable strategy.

Participants The trial population will be comprised of consenting adult patients admitted to general medical or surgical teaching wards at 2 centers, the University of Alberta Hospital in Edmonton and the Foothills Hospital in Calgary.

Randomization

Participants will be randomized to either Control arm or Experimental arm

Control arm (Usual Care): Participants will be discharged as per usual ward discharge protocols. A requisition for follow-up labs (serum creatinine, serum electrolytes, urine albumin/creatinine ratio) to be drawn at 90 days will be given to each participant. Appointments/referrals will be left at the discretion of the care team.

Experimental arm (Risk Guided Follow-up): Participants will be stratified for risk of CKD into three groups: low (<1% risk of CKD), medium (1-10 % risk of CKD) and high (≥10 % risk of CKD) using a risk index developed by the team. Specific follow-up will be guided by risk status.

Analysis Plan:

The primary analysis will follow an intention-to-treat approach. In sensitivity analyses, outcomes based on the predicted risk of CKD will be stratified. Descriptive statistics and bivariate tests of associations will be used as appropriate to evaluate group differences at various time points of follow-up. Associations between key variables and study outcomes will be analyzed using appropriate univariate, multivariate and mixed model multilevel analyses. No interim analyses are planned due to the short duration of the trial.

Being tested
Risk guided follow-up, Usual Care
Medical subject headings
Acute Kidney Injury

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Risk guided follow-upOther

    Participant will be stratified for risk of CKD in three groups: Low (<1% risk of CKD), medium (1-10 % risk of CKD) and high (≥10 % risk of CKD). Specific follow-up will be guided by risk status

  • Usual CareOther

    Participants will be discharged as per usual ward discharge protocols.

Study groups in NCT02915575
Study groupRoleWhat they receive
Control Arm (usual care)OtherParticipants will be discharged as per usual ward discharge protocols.
Receives: Other: Usual Care
Risk guided follow-upOtherParticipant will be stratified for risk of CKD in three groups: Low (<1% risk of CKD), medium (1-10 % risk of CKD) and high (≥10 % risk of CKD). Specific follow-up will be guided by risk status
Receives: Other: Risk guided follow-up

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of patients develop Chronic kidney disease after Acute kidney injury

    The primary (process based) outcome of this trial is the proportion of patients with CKD meeting all three quality of care indicators (statin use, ACEi/ARB use in those with proteinuria (ACR>30mg/mmol) or diabetes, nephrologist visit if sustained eGFR<30ml/min/1.73m2) within 90 days of hospital

    Measured: 90 days

Secondary outcomes (4)
  1. Proportion of patients completed the lab and seen by PCP

    Participant discharged from the hospital will be given lab requisition, to be drawn within 90 days

    Measured: 90 days

  2. check eGFR

    Participant will have their eGFR check at one year

    Measured: one year

  3. Hospitalization

    Proportion of patients hospitalized for AKI or renal specific condition

    Measured: one year

  4. Feasibility

    Proportion of eligible patients recruited in the study

    Measured: one year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Sep 2016 (estimated)
  2. Study start19 Mar 2018
  3. Primary completion31 Dec 2023
  4. Study completion30 Nov 2024

Resources

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
155 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02915575
Sponsor's protocol ID
Pro00067815
Acronym
AFTER AKI
Status last verified
Feb 2025
First submitted
22 Sep 2016
Last updated
3 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Risk guided follow-up in people with Acute Kidney Injury, run by University of Alberta at 2 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 4 inclusion and 4 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: finished, as of the sponsor's last update on 3 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 of patients develop Chronic kidney disease after Acute kidney injury (time frame: 90 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 3 Mar 2025.

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