Use of a Novel Artificial Intelligence Assisted Platform to Assess Optimal Dosing and Treatment Strategy of Erythropoiesis-stimulating Agents (ESA) in Hemodialysis Patients (AI)

Kaohsiung Medical University Chung-Ho Memorial Hospital (KMUH)

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.

Study Overview

• Status: Recruiting
• Conditions: End Stage Renal Disease on Dialysis
• Intervention / Treatment: Device: novel artificial intelligence assisted platform

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

• Study Type: Interventional
• Enrollment (Anticipated): 130
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ping-Hsun Wu, PhD; Phone Number: 7351 07-3121101; Email: 970392KMUH@gmail.com
• Study Contact Backup: Name: YI-PEI CHEN; Phone Number: 7901 07-3121101; Email: joanna9504@gmail.com

Study Locations

• Taiwan
  • Kaohsiung,, Taiwan, 807
    • Recruiting
    • Kaohsiung Medical University Chung-Ho Memorial Hospital (KMUH)
    • Contact: CHEN YI PEI; Phone Number: 7901 07-3121101; Email: joanna9504@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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:

Study Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: GROUP A-AI (model) Arm Description: Artificial intelligence assisted platform supported system for the clinical physicians to prescribe ESA dose to maintain hemoglobin at the treatment target of 10 g/dl to 12 g/dl.	Device: novel artificial intelligence assisted platform; Use of a novel artificial intelligence assisted platform
EXPERIMENTAL: GROUP B-AI (model) Arm Description: ESA dose prescribed by clinical physicians as regular care to maintain hemoglobin at the treatment target of 10 g/dl to 12 g/dl.	Device: novel artificial intelligence assisted platform; Use of a novel artificial intelligence assisted platform

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
hemoglobin (Hb) levels	Maintain hemoglobin at the treatment target of 10 g/dl to 12 g/dl.	6 monthes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the target range (10-12gm/dl)	The Proportion of Participants with haemoglobin within the target range (10-12gm/dl)	6 monthes
The Proportion of Participants Who Received a Whole Blood or Red Blood Cell Transfusion	The Proportion of Participants Who Received a Whole Blood or Red Blood Cell Transfusion	6 monthes

Collaborators and Investigators

• Sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
• Collaborators: National Sun Yat-sen University
• Investigators: Principal Investigator: Ping-Hsun Wu, Kaohsiung Medical University

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 19, 2021
• Primary Completion (ANTICIPATED): December 23, 2023
• Study Completion (ANTICIPATED): December 23, 2023

Study Registration Dates

• First Submitted: August 31, 2021
• First Submitted That Met QC Criteria: August 31, 2021
• First Posted (ACTUAL): September 2, 2021

Study Record Updates

• Last Update Posted (ACTUAL): October 13, 2021
• Last Update Submitted That Met QC Criteria: October 5, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: End Stage Renal Disease; Erythropoiesis stimulating agent; Artificial intelligence assisted platform
• Additional Relevant MeSH Terms: Urologic Diseases; Renal Insufficiency; Renal Insufficiency, Chronic; Kidney Diseases; Kidney Failure, Chronic
• Other Study ID Numbers: KMUHIRB-F(I)-20210040

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No