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.
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
- Conditions the study is for
- Renal Dialysis, Renal Replacement Therapy, Renal Diseases
- 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.
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
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):
- 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.
- 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.
- Implement and evaluate the performance of the developed Machine Learning and Artificial Intelligence algorithms on patient-centered and health economic outcomes.
- 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 group | Role | What they receive |
|---|---|---|
| Critically ill patients requiring acute dialysis | Admitted 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.
Identify Key Performance Indicators that may be used by Machine Learning algorithms.
Key Performance Indicators
Measured: 12 month
Develop Artificial Intelligence and Machine Learning algorithms
Artificial Intelligence and Machine Learning algorithms
Measured: 36 month
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.
- First posted31 Dec 2025
- Study start1 Oct 2026 (estimated)
- Primary completion30 Jun 2030 (estimated)
- Study completion30 Jun 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal DialysisStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 7,500 participants (estimated)
- Target duration
- 90 Days
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Oleksa G Rewa, MD MSc, Principal investigator, University of Alberta
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
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SMART DIALYSIS - Scaling Machine Learning and Artificial Intelligence AlgoRithms to OpTimize the Performance and Delivery of Acute DIALYSIS.
- ClinicalTrials.gov ID
- NCT07312929
- Acronym / sponsor ID
- SMART DIALYSIS / Pro00160780
- Keywords
- Dialysis, Articfical Inteligence, Key performance indicators, Machine Learning
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 7,500 participants (estimated)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 30 Jun 2030 (estimated)
- Study completion
- 30 Jun 2031 (estimated)
- First posted
- 31 Dec 2025 (actual)
- 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.
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, Delivery, and Performance of Acute Dialysis?
Objective(s):
- 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.
- 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.
- Implement and evaluate the performance of the developed Machine Learning and Artificial Intelligence algorithms on patient-centered and health economic outcomes.
- Validate and benchmark the performance of the evaluated Machine Learning and Artificial Intelligence algorithms across multiple jurisdictions.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 90 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Critically ill patients requiring acute dialysis | – | Device: intermittent OR continuous renal replacement therapiesAdmitted to an intensive care unit; requiring acute dialysis |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (1 listed)
- Patients admitted to an intensive care unit (ICU) who require acute renal replacement therapy, either intermittent or continuous.
Key exclusion criteria (2 listed)
- Receipt of renal replacement therapy for less than 24 hours.
- Pre-existing end-stage kidney disease.
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 |
|---|---|---|
| intermittent OR continuous renal replacement therapiesWe will include any critically ill patient admitted to an intensive care unit requiring acute dialysis. | Device | Critically ill patients requiring acute dialysis |
Primary outcome
Identify Key Performance Indicators that may be used by Machine Learning algorithms.
Time frame: 12 month
Key Performance Indicators
Develop Artificial Intelligence and Machine Learning algorithms
Time frame: 36 month
Artificial Intelligence and Machine Learning algorithms
Evaluate the performance of the developed Artificial Intelligence and Machine Learning algorithms.
Time frame: 60 month
ICU and hospital mortality; Renal Recovery at ICU and hospital discharge and 90 days; ICU and hospital lengths of stay; Hospital Costs
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- Individual participant dataSharing planned: Undecided
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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.
Oleksa G Rewa, MD MSc principal investigator
University of Alberta
15 sites in 1 country: see every site and its status.
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.