Machine Learning and Artificial Intelligence Algorithms to Optimize the Performance and Delivery of Acute Dialysis (SMART DIALYSIS)

September 22, 2026 updated by: University of Alberta

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:

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
7500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Oleksa G Rewa, MD MSc FRCPC
  • Phone Number: 17802633280
  • Email: rewa@ualberta.ca

Study Contact Backup

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 2T9
        • Foothills Medical Center
        • Contact:
      • Calgary, Alberta, Canada, T1Y 6J4
        • Peter Lougheed Center
        • Contact:
      • Calgary, Alberta, Canada, T2V 1P9
        • Rockyview General Hospital
        • Contact:
      • Calgary, Alberta, Canada, T3M 1M4
        • South Health Campus
        • Contact:
      • Edmonton, Alberta, Canada, T5H 3V9
        • Royal Alexandra Hospital
        • Contact:
      • Edmonton, Alberta, Canada, T6L 5X8
        • Grey Nuns Community Hospital
        • Contact:
      • Edmonton, Alberta, Canada, T6G-2B7
        • University of Alberta Hospital
        • Contact:
      • Edmonton, Alberta, Canada, T5R 4H5
        • Misericordia Community Hospital
        • Contact:
      • Edmonton, Alberta, Canada, T6G-2B7
        • Mazankowski Heart Institute
        • Contact:
      • Fort McMurray, Alberta, Canada, T9H 1P2
        • Northern Lights Regional Hospital.
        • Contact:
      • Grand Prairie, Alberta, Canada, T8V 4B1
        • Grand Prairie Regional Hospital
        • Contact:
      • Lethbridge, Alberta, Canada, T1J 1W5
        • Chinook Regional Hospital
        • Contact:
      • Medicine Hat, Alberta, Canada, T1A 4H6
        • Medicine Hat Regional Hospital
        • Contact:
      • Red Deer, Alberta, Canada, T4N 4E7
        • Red Deer Regional Hospital
        • Contact:
      • St. Albert, Alberta, Canada, T8N 6C4
        • Sturgeon Community Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

Inclusion Criteria

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

Exclusion Criteria

Receipt of renal replacement therapy for less than 24 hours.

Pre-existing end-stage kidney disease.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: COHORT
  • Time Perspectives: PROSPECTIVE

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Critically ill patients requiring acute dialysis

Admitted to an intensive care unit; requiring acute dialysis
Device: intermittent OR continuous renal replacement therapies

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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Identify Key Performance Indicators that may be used by Machine Learning algorithms.
Time Frame: 12 month

Key Performance Indicators
12 month
Develop Artificial Intelligence and Machine Learning algorithms
Time Frame: 36 month

Artificial Intelligence and Machine Learning algorithms
36 month
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
60 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Alberta

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Oleksa G Rewa, MD MSc, University of Alberta

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2030

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2031

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 17, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 17, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 31, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 24, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 22, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Pro00160780

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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