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Renal DialysisSMART DIALYSISNCT07312929

Machine Learning and Artificial Intelligence Algorithms to Optimize the Performance and Delivery of Acute Dialysis

An observational study of Renal Dialysis and Renal Replacement Therapy, run by University of Alberta at 15 sites in Canada.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

SMART DIALYSIS - Scaling Machine Learning and Artificial Intelligence AlgoRithms to OpTimize the Performance and Delivery of Acute DIALYSIS. Hypothesis: Can the investigators develop and implement Machine Learning and Artificial Intelligence Algorithms into Clinical Information Systems to Optimize the Prescription… Read more about this study

Who is it for?
Any age
What is being tested?
intermittent OR continuous renal replacement therapies
Type of treatment
Medical device
How many people
7,500 participants
Where
15 sitesCanada
Study dates
1 Oct 2026to 30 Jun 2031
How long will I take part?
90 Days
Phase
Observational
Are there results?
Not yet: the study is under way

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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: The study population will comprise critically ill patients admitted to an intensive care unit who require acute renal replacement therapy.

Who may be able to join

  • Patients admitted to an intensive care unit (ICU) who require acute renal replacement therapy, either intermittent or continuous.

Who cannot join

  • Receipt of renal replacement therapy for less than 24 hours.
  • Pre-existing end-stage kidney disease.

Trial locations and contacts

15 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Oleksa G Rewa, MD MSc FRCPC contact

17802633280

rewa@ualberta.ca

Fadi Hammal, MD MSc contact

5879907454

hammal@ualberta.ca

15 sites in 1 country

Canada15 sites
  • Peter Lougheed Center

    Calgary, Alberta, T1Y 6J4

    Oleksa Rewa, MD, 7802633280, rewa@ualberta.ca

  • Foothills Medical Center

    Calgary, Alberta, T2N 2T9

    Oleksa Rewa, MD, 7802633280, rewa@ualberta.ca

  • Rockyview General Hospital

    Calgary, Alberta, T2V 1P9

    Oleksa Rewa, MD, 7802633280, rewa@ualberta.ca

  • South Health Campus

    Calgary, Alberta, T3M 1M4

    Oleksa Rewa, MD, 7802633280, rewa@ualberta.ca

  • Royal Alexandra Hospital

    Edmonton, Alberta, T5H 3V9

    Oleksa Rewa, MD, 7802633280, rewa@ualberta.ca

  • Misericordia Community Hospital

    Edmonton, Alberta, T5R 4H5

    Oleksa Rewa, MD, 7802633280, rewa@ualberta.ca

  • Mazankowski Heart Institute

    Edmonton, Alberta, T6G-2B7

    Oleksa Rewa, MD, 7802633280, rewa@ualberta.ca

  • University of Alberta Hospital

    Edmonton, Alberta, T6G-2B7

    Oleksa Rewa, MD, 7802633280, rewa@ualberta.ca

  • Grey Nuns Community Hospital

    Edmonton, Alberta, T6L 5X8

    Oleksa Rewa, MD, 7802633280, rewa@ualberta.ca

  • Northern Lights Regional Hospital.

    Fort McMurray, Alberta, T9H 1P2

    Oleksa Rewa, MD, 7802633280, rewa@ualberta.ca

  • Grand Prairie Regional Hospital

    Grand Prairie, Alberta, T8V 4B1

    Oleksa Rewa, MD, 7802633280, rewa@ualberta.ca

  • Chinook Regional Hospital

    Lethbridge, Alberta, T1J 1W5

    Oleksa Rewa, MD, 7802633280, rewa@ualberta.ca

  • Medicine Hat Regional Hospital

    Medicine Hat, Alberta, T1A 4H6

    Oleksa Rewa, MD, 7802633280, rewa@ualberta.ca

  • Red Deer Regional Hospital

    Red Deer, Alberta, T4N 4E7

    Oleksa Rewa, MD, 7802633280, rewa@ualberta.ca

  • Sturgeon Community Hospital

    St. Albert, Alberta, T8N 6C4

    Oleksa Rewa, MD, 7802633280, rewa@ualberta.ca

Other trials in Canada

About this study

Official title: SMART DIALYSIS - Scaling Machine Learning and Artificial Intelligence AlgoRithms to OpTimize the Performance and Delivery of Acute DIALYSIS.

SMART DIALYSIS - Scaling Machine Learning and Artificial Intelligence AlgoRithms to OpTimize the Performance and Delivery of Acute DIALYSIS.

Hypothesis:

Read more

Can the investigators develop and implement Machine Learning and Artificial Intelligence Algorithms into Clinical Information Systems to Optimize the Prescription, Delivery, and Performance of Acute Dialysis?

Objective(s):

  1. Identify variables surrounding identified Key Performance Indicators that may be used by Machine Learning and Artificial Intelligence algorithms to optimize the prescription and performance of acute dialysis.
  2. Develop Machine Learning and Artificial Intelligence algorithms to help guide the prescription and delivery of acute dialysis in the development of Clinical Decision Support tools and Best Practice Advisories and create a ML/AI Augmented SMART DIALYSIS Digital Dashboard.
  3. Implement and evaluate the performance of the developed Machine Learning and Artificial Intelligence algorithms on patient-centered and health economic outcomes.
  4. Validate and benchmark the performance of the evaluated Machine Learning and Artificial Intelligence algorithms across multiple jurisdictions.
Read the detailed description

Study Background \& Rationale:

Acute dialysis is required in approximately 10-15% of all patients admitted to intensive care units (ICUs). Acute dialysis may take the form of continuous renal replacement therapy (CRRT), intermittent hemodialysis (IHD) or slow-low efficiency dialysis (SLED). Worldwide, CRRT remains the predominant form of acute dialysis, with over 75% of acute dialysis being CRRT.

The application of acute dialysis in the ICU is associated with poor patient outcomes. Despite advances in medical technology and care, mortality remains between 40-60%, which is similar to outcomes observed with severe acute respiratory distress syndrome (ARDS). Additionally, even when patients survive their critical illness, up to 10% of patients require ongoing long-term chronic dialysis therapy. This has a significant effect on the quality of life of survivors of critical illness, as well as important effects on their families, often requiring changes in work and housing status, as well as relocation to sites in closer proximity to dialysis centres. This results in not only significant healthcare and social costs (approximately $100,000/patient/year in Alberta, Canada), but also very important reductions in the health-related quality of lives for these patients. Currently, while evidence exist regarding the optimal initiation of acute dialysis, there is a paucity of evidence to predict timing of modality transition or liberation from this therapy. Using a completely integrated electronic Clinical Information System (eCIS) such as Connect Care (EPIC, Wisconsin, USA) in Alberta, the investigators can develop predictive algorithms that may anticipate patient and acute dialysis needs.

Once, acute dialysis is initiated, several factors may affect kidney recovery following acute dialysis. Intra-dialytic hypotension has been identified as a leading modifiable factor, but unfortunately, one where clinicians have limited capacity to accurately predict. This is an important knowledge gap that must be addressed. It has also been previously identified by our study team as one of the most important key performance indicators (KPI) for acute dialysis, especially in IHD and SLED. For CRRT, filter life has been identified as the most important and studied KPI. Both of these KPIs are currently being utilized by the ongoing QUALITY CRRT and DIALYZING WISELY programs to improve the performance and delivery of acute dialysis to critically ill patients. These two programs have been successfully implemented across Alberta and have established the infrastructure necessary to initiate the next steps in these Continuous Quality Initiatives for acute dialysis, the SMART DIALYSIS program.

Recently, advances in computer and machine processing have led to the 4th industrial revolution featuring the development of smart machines, devices, and learning algorithms that can aid humans in the management of patients and optimize the delivery of healthcare. Machine Learning (ML) and Artificial Intelligence (AI) algorithms have been previously used in medicine, but have only begun their implementation into critical care nephrology.

Current initiatives are primarily focused on pattern recognition and risk prediction. This program will contain 4 distinct phases.

In Phase 1, the investigators will continue work from our QUALITY CRRT and DIALYZING WISELY program and will aim to better understand the landscape surrounding decisions around transitions between acute dialysis modalities, termination, and attempts at liberation from acute dialysis, the incidence of intra-dialytic hypotension, and timing of filter clotting in the ICU.

In Phase 2, the investigators will develop models and subsequent Clinical Decision Support (CDS) tools and/or Best Practice Advisories (BPAs) for clinicians to better predict and manage 1) transitions between acute dialysis therapies, 2) management of intra-dialytic hypotension, 3) prediction of filter life and 4) liberation from acute dialysis. Concurrent with this work, we will work to develop an AI/ML Augmented Acute Dialysis Dashboard (i.e., SMART DIALYSIS Digital Dashboard) embedded within our electronic Clinical Information System (eCIS) to present these KPIs to clinicians.

Phase 3 will look into implementing and evaluating the performance and acceptability of these ML/AI algorithms in clinical practice.

Finally, Phase 4 will take our Alberta-derived results and look to implement and benchmark these across other large healthcare authorities to ensure that the algorithms have been developed and validated appropriately and ethically. These will include partners across Canada, the US, Europe and Australia and New Zealand.

Being tested
intermittent OR continuous renal replacement therapies
Keywords
Dialysis, Articfical Inteligence, Key performance indicators, Machine Learning
Medical subject headings
Kidney Diseases

What participants receive

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

  • intermittent OR continuous renal replacement therapiesDevice

    We will include any critically ill patient admitted to an intensive care unit requiring acute dialysis.

Study groups in NCT07312929
Study groupRoleWhat they receive
Critically ill patients requiring acute dialysisAdmitted to an intensive care unit; requiring acute dialysis
Receives: Device: intermittent OR continuous renal replacement therapies

What is being measured

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

  1. Identify Key Performance Indicators that may be used by Machine Learning algorithms.

    Key Performance Indicators

    Measured: 12 month

  2. Develop Artificial Intelligence and Machine Learning algorithms

    Artificial Intelligence and Machine Learning algorithms

    Measured: 36 month

  3. Evaluate the performance of the developed Artificial Intelligence and Machine Learning algorithms.

    ICU and hospital mortality; Renal Recovery at ICU and hospital discharge and 90 days; ICU and hospital lengths of stay; Hospital Costs

    Measured: 60 month

Timeline

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

  1. First posted31 Dec 2025
  2. Study start1 Oct 2026 (estimated)
  3. Primary completion30 Jun 2030 (estimated)
  4. Study completion30 Jun 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
7,500 participants (estimated)
Target duration
90 Days
IDs, dates and publications
ClinicalTrials.gov ID
NCT07312929
Sponsor's protocol ID
Pro00160780
Acronym
SMART DIALYSIS
Status last verified
Sep 2026
First submitted
17 Dec 2025
Last updated
24 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Renal Dialysis and Renal Replacement Therapy, run by University of Alberta at 15 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 1 inclusion and 2 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: opening soon, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Oleksa G Rewa, MD MSc FRCPC (17802633280, rewa@ualberta.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Identify Key Performance Indicators that may be used by Machine Learning algorithms. (time frame: 12 month). The study lists 3 primary outcomes in all. 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 24 Sep 2026.

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