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

Primary Purpose

End Stage Renal Disease on Dialysis

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
novel artificial intelligence assisted platform
Sponsored by
Kaohsiung Medical University Chung-Ho Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for End Stage Renal Disease on Dialysis focused on measuring End Stage Renal Disease, Erythropoiesis stimulating agent, Artificial intelligence assisted platform

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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The eligible subject will not be allowed to continue the study once informed consent is withdrawn or event happening meets the following criteria:

Sites / Locations

  • Kaohsiung Medical University Chung-Ho Memorial Hospital (KMUH)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

GROUP A-AI (model) Arm Description:

GROUP B-AI (model) Arm Description:

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.

ESA dose prescribed by clinical physicians as regular care to maintain hemoglobin at the treatment target of 10 g/dl to 12 g/dl.

Outcomes

Primary Outcome Measures

hemoglobin (Hb) levels
Maintain hemoglobin at the treatment target of 10 g/dl to 12 g/dl.

Secondary Outcome Measures

the target range (10-12gm/dl)
The Proportion of Participants with haemoglobin within the target range (10-12gm/dl)
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

Full Information

First Posted
August 31, 2021
Last Updated
October 5, 2021
Sponsor
Kaohsiung Medical University Chung-Ho Memorial Hospital
Collaborators
National Sun Yat-sen University
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1. Study Identification

Unique Protocol Identification Number
NCT05032651
Brief Title
Use of a Novel Artificial Intelligence Assisted Platform to Assess Optimal Dosing and Treatment Strategy of Erythropoiesis-stimulating Agents (ESA) in Hemodialysis Patients
Acronym
AI
Official Title
Kaohsiung Medical University Chung-Ho Memorial Hospital (KMUH)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Recruiting
Study Start Date
March 19, 2021 (Actual)
Primary Completion Date
December 23, 2023 (Anticipated)
Study Completion Date
December 23, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kaohsiung Medical University Chung-Ho Memorial Hospital
Collaborators
National Sun Yat-sen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Renal Disease on Dialysis
Keywords
End Stage Renal Disease, Erythropoiesis stimulating agent, Artificial intelligence assisted platform

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
130 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
GROUP A-AI (model) Arm Description:
Arm Type
Experimental
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.
Arm Title
GROUP B-AI (model) Arm Description:
Arm Type
Experimental
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.
Intervention Type
Device
Intervention Name(s)
novel artificial intelligence assisted platform
Intervention Description
Use of a novel artificial intelligence assisted platform
Primary Outcome Measure Information:
Title
hemoglobin (Hb) levels
Description
Maintain hemoglobin at the treatment target of 10 g/dl to 12 g/dl.
Time Frame
6 monthes
Secondary Outcome Measure Information:
Title
the target range (10-12gm/dl)
Description
The Proportion of Participants with haemoglobin within the target range (10-12gm/dl)
Time Frame
6 monthes
Title
The Proportion of Participants Who Received a Whole Blood or Red Blood Cell Transfusion
Description
The Proportion of Participants Who Received a Whole Blood or Red Blood Cell Transfusion
Time Frame
6 monthes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: signed informed consent Age older than 20 year old. End stage renal disease under regular hemodialysis with three times per week and duration of each session at least 4 hours 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 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 Having received ESA of the same brand at least 6 months before the enrollment Exclusion Criteria: Ever receiving blood transfusion in the past 12 months Active bleeding with blood loss more than 250cc in 3 months before the enrollment Active infection or malignancy 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:
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ping-Hsun Wu, PhD
Phone
07-3121101
Ext
7351
Email
970392KMUH@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
YI-PEI CHEN
Phone
07-3121101
Ext
7901
Email
joanna9504@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ping-Hsun Wu
Organizational Affiliation
Kaohsiung Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kaohsiung Medical University Chung-Ho Memorial Hospital (KMUH)
City
Kaohsiung,
ZIP/Postal Code
807
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
CHEN YI PEI
Phone
07-3121101
Ext
7901
Email
joanna9504@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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