ClinicalTrials.gg
Not yet recruitingNCT07312929SMART DIALYSISUpdated Sep 24, 2026

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

An observational study in Renal Dialysis, Renal Replacement Therapy and Renal Diseases, sponsored by University of Alberta. Not yet recruiting at 15 sites in Canada. Per ClinicalTrials.gov, last updated 2026-09-24.

Sponsored by University of Alberta · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
7,500
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 83 studies in Kidney Diseases with a site in Canada — 15 open to participants now, 25 under way, 9 of them phase 3. Kidney Diseases · Canada.

Planned enrollment
5th of 24
7,500 · median 473
Started
2026
with 2 others
Observational
24 of 83
7 open now
Primary completion
2030-06
later than 18 of 24 live
Registered
80th of 83
by date
Lead sponsor
3 of 83
University of Alberta

Among the 83 studies in Kidney Diseases with a site in Canada, this one is the 5th largest by planned enrollment of the 24 observational ones, is one of 3 that started in 2026, is one of 24 observational ones, reaches primary completion later than 18 of the 24 other live ones, and was the 80th registered.

By phase

83 studies; the count open now beside each. This study's row is marked.

Observationalthis study24 · 7 open
No phase21 · 3 open
Phase 318 · 4 open
Phase 211 · 0 open
Phase 45 · 0 open
Phase 1/23 · 1 open
Phase 11 · 0 open

By the year they started

First in 1997; this study’s year is marked. 3 started in 2026.

Size and results

Median enrollment 155 across the 59 interventional studies, 473 across the 24 observational. Of the 53 that completed or were terminated, 17 (32%) have results posted.

Was this useful?
Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 83 studies in Kidney Diseases with a site in Canada, or all of them as a file.
02

Study 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, 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.

03

Conditions studied

  • Renal Dialysis
  • Renal Replacement Therapy
  • Renal Diseases
  • Quality Health Care

Browse trials for

Keywords

  • Dialysis
  • Articfical Inteligence
  • Key performance indicators
  • Machine Learning
04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria

Receipt of renal replacement therapy for less than 24 hours.

Pre-existing end-stage kidney disease.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
7,500 participants (estimated)
Target follow-up
90 Days
Patient registry
Yes

Groups and cohorts

  • Critically ill patients requiring acute dialysis

    Admitted to an intensive care unit; requiring acute dialysis

    Device: intermittent OR continuous renal replacement therapies

Interventions

  • Deviceintermittent OR continuous renal replacement therapies

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

06

What researchers measure

Primary outcomes

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

    Key Performance Indicators

    Time frame: 12 month

  2. Develop Artificial Intelligence and Machine Learning algorithms

    Artificial Intelligence and Machine Learning algorithms

    Time frame: 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

    Time frame: 60 month

07

Study locations

15 sites
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Oct 2026; primary completion for Jun 2030, 44 months later.

Of 99 non-industry observational studies under Kidney Diseases, half reached primary completion within 68 months of starting (the median), counting those still running; a quarter within 33. This study's planned 44 months is below that.

Counting every sponsor, half of 116 studies reached it within 59 months; a quarter within 28 and three quarters within 118.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 17, 2025
First posted
Dec 31, 2025
StartEst.
Oct 1, 2026
Primary completionEst.
Jun 30, 2030
CompletionEst.
Jun 30, 2031
Last update
Sep 24, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 24, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07312929
Responsible party
Sponsor
First posted
Dec 31, 2025
Start date
Oct 1, 2026 (estimated)
Primary completion
Jun 30, 2030 (estimated)
Completion
Jun 30, 2031 (estimated)
Last update
Sep 24, 2026

Study contacts

Oleksa G Rewa, MD MSc FRCPC
Contact
rewa@ualberta.ca
17802633280
Fadi Hammal, MD MSc
Contact
hammal@ualberta.ca
5879907454
Oleksa G Rewa, MD MSc
principal investigator · University of Alberta

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion