Algoritmos de Aprendizaje Automático e Inteligencia Artificial para Optimizar el Rendimiento y la Prestación de Diálisis Aguda (SMART DIALYSIS)
SMART DIALYSIS - Escalando Algoritmos de Aprendizaje Automático e Inteligencia Artificial para Optimizar el Rendimiento y la Prestación de Diálisis Aguda.
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.
Descripción general del estudio
Estado
Estado
Condiciones
Condiciones
Intervención / Tratamiento
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Tipo de estudio
Inscripción (Estimado)
Inscripción
Contactos y Ubicaciones
Estudio Contacto
Estudio Contacto
- Nombre: Oleksa G Rewa, MD MSc FRCPC
- Número de teléfono: 17802633280
- Correo electrónico: rewa@ualberta.ca
Copia de seguridad de contactos de estudio
- Nombre: Fadi Hammal, MD MSc
- Número de teléfono: 5879907454
- Correo electrónico: hammal@ualberta.ca
Ubicaciones de estudio
-
-
Alberta
-
Calgary, Alberta, Canadá, T2N 2T9
- Foothills Medical Center
-
Contacto:
- Oleksa Rewa, MD
- Número de teléfono: 7802633280
- Correo electrónico: rewa@ualberta.ca
-
Calgary, Alberta, Canadá, T1Y 6J4
- Peter Lougheed Center
-
Contacto:
- Oleksa Rewa, MD
- Número de teléfono: 7802633280
- Correo electrónico: rewa@ualberta.ca
-
Calgary, Alberta, Canadá, T2V 1P9
- Rockyview General Hospital
-
Contacto:
- Oleksa Rewa, MD
- Número de teléfono: 7802633280
- Correo electrónico: rewa@ualberta.ca
-
Calgary, Alberta, Canadá, T3M 1M4
- South Health Campus
-
Contacto:
- Oleksa Rewa, MD
- Número de teléfono: 7802633280
- Correo electrónico: rewa@ualberta.ca
-
Edmonton, Alberta, Canadá, T5H 3V9
- Royal Alexandra Hospital
-
Contacto:
- Oleksa Rewa, MD
- Número de teléfono: 7802633280
- Correo electrónico: rewa@ualberta.ca
-
Edmonton, Alberta, Canadá, T6L 5X8
- Grey Nuns Community Hospital
-
Contacto:
- Oleksa Rewa, MD
- Número de teléfono: 7802633280
- Correo electrónico: rewa@ualberta.ca
-
Edmonton, Alberta, Canadá, T6G-2B7
- University of Alberta Hospital
-
Contacto:
- Oleksa Rewa, MD
- Número de teléfono: 7802633280
- Correo electrónico: rewa@ualberta.ca
-
Edmonton, Alberta, Canadá, T5R 4H5
- Misericordia Community Hospital
-
Contacto:
- Oleksa Rewa, MD
- Número de teléfono: 7802633280
- Correo electrónico: rewa@ualberta.ca
-
Edmonton, Alberta, Canadá, T6G-2B7
- Mazankowski Heart Institute
-
Contacto:
- Oleksa Rewa, MD
- Número de teléfono: 7802633280
- Correo electrónico: rewa@ualberta.ca
-
Fort McMurray, Alberta, Canadá, T9H 1P2
- Northern Lights Regional Hospital.
-
Contacto:
- Oleksa Rewa, MD
- Número de teléfono: 7802633280
- Correo electrónico: rewa@ualberta.ca
-
Grand Prairie, Alberta, Canadá, T8V 4B1
- Grand Prairie Regional Hospital
-
Contacto:
- Oleksa Rewa, MD
- Número de teléfono: 7802633280
- Correo electrónico: rewa@ualberta.ca
-
Lethbridge, Alberta, Canadá, T1J 1W5
- Chinook Regional Hospital
-
Contacto:
- Oleksa Rewa, MD
- Número de teléfono: 7802633280
- Correo electrónico: rewa@ualberta.ca
-
Medicine Hat, Alberta, Canadá, T1A 4H6
- Medicine Hat Regional Hospital
-
Contacto:
- Oleksa Rewa, MD
- Número de teléfono: 7802633280
- Correo electrónico: rewa@ualberta.ca
-
Red Deer, Alberta, Canadá, T4N 4E7
- Red Deer Regional Hospital
-
Contacto:
- Oleksa Rewa, MD
- Número de teléfono: 7802633280
- Correo electrónico: rewa@ualberta.ca
-
St. Albert, Alberta, Canadá, T8N 6C4
- Sturgeon Community Hospital
-
Contacto:
- Oleksa Rewa, MD
- Número de teléfono: 7802633280
- Correo electrónico: rewa@ualberta.ca
-
-
Criterios de participación
Criterio de elegibilidad
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
The study population will comprise critically ill patients admitted to an intensive care unit who require acute renal replacement therapy.
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: COHORT
- Perspectivas temporales: PROSPECTIVE
Número de grupos/cohortes
Cohortes e Intervenciones
Grupo / CohorteGrupo / Cohorte |
Intervención / TratamientoIntervención / Tratamiento |
|---|---|
|
Critically ill patients requiring acute dialysis
Admitted to an intensive care unit; requiring acute dialysis |
We will include any critically ill patient admitted to an intensive care unit requiring acute dialysis. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Identify Key Performance Indicators that may be used by Machine Learning algorithms.
Periodo de tiempo: 12 month
|
Key Performance Indicators |
12 month
|
|
Develop Artificial Intelligence and Machine Learning algorithms
Periodo de tiempo: 36 month
|
Artificial Intelligence and Machine Learning algorithms |
36 month
|
|
Evaluate the performance of the developed Artificial Intelligence and Machine Learning algorithms.
Periodo de tiempo: 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
|
Colaboradores e Investigadores
Patrocinador
Patrocinador
Investigadores
Investigadores
- Investigador principal: Oleksa G Rewa, MD MSc, University of Alberta
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Inicio del estudio
Finalización primaria (Estimado)
Finalización primaria
Finalización del estudio (Estimado)
Finalización del estudio
Fechas de registro del estudio
Enviado por primera vez
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Publicado por primera vez
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización publicada
Última actualización enviada que cumplió con los criterios de control de calidad
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
Otros números de identificación del estudio
- Pro00160780
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .