Prescription d'ESA assistée par l'IA pour la gestion de l'hémoglobine des patients sous hémodialyse
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)
Maladies génito-urinaires+10
+ Maladie chronique
+ Maladies urogénitales féminines et complications de la grossesse
Autre étude
Résumé
Date de début de l'étude : 24 juillet 2019
Date à laquelle le premier participant a commencé l'étude.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.
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.126 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Autre
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Tout sexe
Le sexe biologique des participants éligibles à s'inscrire.À partir de 20 ans
Tranche d'âge des participants éligibles à participer.Volontaires sains non autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
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 l'étude
Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.Un seul groupe d'intervention est désigné dans cette étude
Cette étude ne comporte pas de groupe placebo.
Groupes de traitement
Groupe I
ExpérimentalObjectifs de l'étude
Objectifs principaux
Centres d'étude
Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.Cette étude comporte 1 site
Kaohsiung Medical University Chung-Ho Memorial Hospital (KMUH)
Kaohsiung City, TaiwanOuvrir Kaohsiung Medical University Chung-Ho Memorial Hospital (KMUH) dans Google Maps