Clinical trial NCT05032651: Use of a Novel Artificial Intelligence Assisted Platform to Assess Optimal Dosing and Treatment Strategy of Erythropoiesis-stimulating Agents (ESA) in Hemodialysis Patients
Official title: Kaohsiung Medical University Chung-Ho Memorial Hospital (KMUH)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: End Stage Renal Disease on Dialysis
Keywords: End Stage Renal Disease
Erythropoiesis stimulating agent
Artificial intelligence assisted platform
Lead sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
Sponsor class: OTHER
Collaborators: name: National Sun Yat-sen University
First posted: 2021-09-02
Enrollment: 130
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 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.

Study period
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed description: 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

Eligibility criteria: 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

Exclusion Criteria:

1. Ever receiving blood transfusion in the past 12 months
2. Active bleeding with blood loss more than 250cc in 3 months before the enrollment
3. Active infection or malignancy
4. Study subject can not follow with the study protocol

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:

Primary outcomes:
measure: hemoglobin (Hb) levels
timeFrame: 6 monthes
Secondary outcomes:
measure: the target range (10-12gm/dl)
timeFrame: 6 monthes
measure: The Proportion of Participants Who Received a Whole Blood or Red Blood Cell Transfusion
timeFrame: 6 monthes
Other outcomes:
Locations:
city: Kaohsiung,
country: Taiwan
facility: Kaohsiung Medical University Chung-Ho Memorial Hospital (KMUH)
Study officials:
affiliation: Kaohsiung Medical University
name: Ping-Hsun Wu
role: PRINCIPAL_INVESTIGATOR
References: