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Clinical Trials/NCT07312929
NCT07312929Not yet recruitingNot Applicable

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

University of Alberta0 sites7,500 target enrollmentStarted: June 1, 2026Last updated:
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
7,500
Primary Endpoint
Identify Key Performance Indicators that may be used by Machine Learning algorithms.

Study Overview

Brief 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.

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
No

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.

Arms & Interventions

Critically ill patients requiring acute dialysis

Admitted to an intensive care unit; requiring acute dialysis

Intervention: intermittent OR continuous renal replacement therapies (Device)

Outcomes

Primary Outcomes

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Oleksa Rewa

Associate Professor, Director of Research & Innovation

University of Alberta

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