A Model of Computer-assisted Prescription of Erythropoiesis-stimulating Agents (ESA) in Patients Under Hemodialysis
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- End Stage Renal Disease
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Informed consent must be signed before any procedures related to the study for any participant. The subject who meets the inclusion and exclusion criteria will be enrolled and a total of 126 subjects needed to have the power to test the hypothesis. In addition to the Hb levels and EAS doses, all HD-related bio information data in 12 consecutive months before enrollment will be uploaded into the model for further ESA dose prediction. Before randomization, the study subject will continue to receive the ESA by the prescription from the physician. Randomization period All eligible subjects will be randomized 1:1 by their age, gender, and HD vintage into control arm and intervention arm. After randomization, the study subject will enter the study after the nearest Hb measurement coming.Masking: Single (Investigator)Primary Purpose: Other
Participation Requirements
- Age
- Between 20 years and 125 years
- Gender
- Both males and females
Description
It has been known well for a long time that End stage renal disease (ESRD) patients usually need ESA to maintain their hemoglobin (Hb) to improve both mortality as well as quality of life. Later, several large-scale RCTs showing normalization of Hb in this population increased the risk of thromboemb...
It has been known well for a long time that End stage renal disease (ESRD) patients usually need ESA to maintain their hemoglobin (Hb) to improve both mortality as well as quality of life. Later, several large-scale RCTs showing normalization of Hb in this population increased the risk of thromboembolic event, which leaded current guidelines to recommend the therapeutic goal for anemia in ESRD should be within a range (usually between 10-12 gm/dl) rather than above or below a certain level (or value). In addition to ESA dose, many factors contribute to the severity of anemia in this population, such as iron status, chronic blood loss, adequacy of dialysis, chronic inflammation, renal wasting, et al. To put all these factors together, maintaining the Hb levels within the target level is a challenge to physician. It was reported that only one third of Hb within the target at any given time. Our data showed, for those under maintenance hemodialysis and without any blood transfusion in observation period, near two third of patients' Hb level were within the target range. For better anemia management, NKF-K/DOQI developed and published guidelines using protocol or algorithm for EPO prescription.6 Recently, artificial intelligence (AI) has been widely applied to medicine in the field of reducing human error, robotic surgical system and decision- making aid. Since then, there were several studies working on decision making programs to set up model of predicting the ESA dose needed for target Hb level. Artificial neural network (ANN) model is most commonly used for ESA dose-response prediction. However, the effectiveness of these kinds of AI is not confirmed clinically and the result not satisfactory. In other words, it is still inconclusive whether contemporary AI has any role in decision making aid when prescribing ESA dose for dialysis patient, a typical trial and error which AI supposed should be very helpful with. Based on the mentioned above, we are going to conduct this clinical try to test the hypothesis that AI is not inferior to physician in prescribing ESA dose for hemodialysis patients to maintain hemoglobin(Hb) level to meet the target
Tracking Information
- NCT #
- NCT04185519
- Collaborators
- Not Provided
- Investigators
- Not Provided
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