Prescripción de ESA asistida por IA para el manejo de hemoglobina en pacientes de hemodiálisis
This study aims to evaluate the effectiveness of AI-Assisted ESA Prescription compared to conventional methods in managing hemoglobin levels in hemodialysis patients.
AI (model)
Enfermedades Urogenitales+5
+ Enfermedad Crónica
+ Enfermedades Urogenitales Femeninas y Complicaciones del Embarazo
Otro tipo de estudio
Resumen
Fecha de inicio: 24 de julio de 2019
Fecha en la que se inscribió al primer participante.This clinical trial focuses on End Stage Renal Disease (ESRD) patients who are undergoing hemodialysis. These patients often need a medication called Erythropoiesis-stimulating Agents (ESA) to keep their hemoglobin (Hb) levels balanced, which is crucial for improving their quality of life and reducing mortality risk. However, maintaining the right Hb level is challenging due to various factors like iron status, chronic blood loss, and inflammation. The study aims to improve anemia management in these patients by testing if Artificial Intelligence (AI) can be as effective as physicians in prescribing the right dose of ESA. During the trial, participants will receive ESA either through the conventional method (as decided by a physician) or based on AI recommendations. The primary outcome measured will be the change in hemoglobin (Hb) levels from a base point of 11g/dl during the evaluation period. The study will compare these changes in both groups using a logistic regression model. This model will consider factors like treatment type (AI or conventional), the center where the treatment is provided, and the interaction between treatment and center. The study will then calculate the treatment effects and their confidence intervals to determine if AI is as effective as conventional methods.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 126 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Otro Tipo de Estudio
Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Cualquier sexo
Sexo biológico de los participantes elegibles para inscribirse.A partir de 20 años
Rango de edades de los participantes que pueden unirse al estudio.Voluntarios sanos no permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Condiciones
Patología
Criterios
1\. Main inclusion criteria: 1. signed informed consent 2. Age older than 20 year old. 3. End stage renal disease under regular hemodialysis with three times per week and duration of each session at least 4 hours 4. Having at least consecutive 6 months data of both Hb and biochemical study during dialysis before enrollment and at least one Hb level within the range of 11-12 g/dl 5. Having at least one prescription of ESA supplement to keep Hb within the range of 10-12 g/dl in the past 6 months before the enrollment 6. Having received ESA of the same brand at least 6 months before the enrollment 2\. Main exclusion criteria: 1. Ever receiving blood transfusion in the past 12 months 2. Active bleeding with blood loss more than250cc in 3 months before the enrollment 3. Active infection or malignancy 4. Study subject can not follow with the study protocol 3. End of Study The eligible subject will not be allowed to continue the study once informed consent is withdrawn or event happening meets the following criteria: 1. Taking extra ESAs, Androgens and iron-chelating agents 2. Undergoing surgery with massive haemorrhage, or blood transfusion 3. Receiving systemic chemotherapy or radiotherapy or immunosuppressive therapies. 4. The end of study will be 6 months later after the randomization of last study subject or failed prescription rate higher than 5%, which comes earlier.
Plan de Estudio
Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.Un solo grupo de intervención está designado en este estudio
0% de probabilidad de ser asignado al grupo placebo
Grupos de Tratamiento
Grupo I
ExperimentalObjetivos del Estudio
Objetivos Primarios
Centros del Estudio
Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.Este estudio tiene una ubicación
Kaohsiung Medical University Chung-Ho Memorial Hospital (KMUH)
Kaohsiung City, TaiwanAbrir Kaohsiung Medical University Chung-Ho Memorial Hospital (KMUH) en Google Maps