AI-Assisted ESA Prescription for Hemodialysis Patients' Hemoglobin Management
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)
Urogenital Diseases+10
+ Chronic Disease
+ Female Urogenital Diseases and Pregnancy Complications
Other Study
Summary
Study start date: July 24, 2019
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.126 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Other Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 20 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
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.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Kaohsiung Medical University Chung-Ho Memorial Hospital (KMUH)
Kaohsiung City, TaiwanOpen Kaohsiung Medical University Chung-Ho Memorial Hospital (KMUH) in Google Maps